Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial

Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial Hubert de Boysson, Kim Heang Ly, Loïk Geffray, Thomas Quemeneur, and 14 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5231536/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 07 Jun, 2025 Read the published version in Arthritis Research & Therapy → Version 1 posted 11 You are reading this latest preprint version Abstract Background Efficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed. Methods This phase 3 study (NCT02902731) was a prospective multicenter, randomized, double-blind, placebo-controlled trial conducted over a 52-week period. GCA patients were randomized 1:1. From inclusion to week 16 (W16), patients in the anakinra (ANK) group received a daily subcutaneous injection of 100 mg of anakinra, whereas patients in the other group received placebo (PBO). In both arms, glucocorticoid (GC) discontinuation was planned at week 52 (W52). The endpoints were the relapse rates at W16, W26, and W52 and the completion of GC tapering. Given the emergence of the SARS-CoV-2 pandemic, the study was stopped prematurely. Results Thirty patients with new GCA diagnoses from 5 centers were randomized as follows: 17 in the ANK group and 13 in the PBO group. During the first 16 weeks, the relapse rates were 12% (n = 2) and 23% (n = 3) in the ANK and PBO groups, respectively (p = 0.63). At week 26, 12 (40%) patients had relapsed: 8 (47%) in the ANK group and 4 (31%) in the PBO group (p = 0.47). At W52, the relapse rate (overall, 50%) did not differ between the ANK group (53%; 9/17 patients) and the PBO group (46%; 6/13 patients) (p = 1). Two patients in each group discontinued GCs (p = 0.87). Seven serious AEs were reported in five patients, including 4 in patients receiving ANK. Conclusions Although prematurely discontinued, this study does not support the use of 4 months of treatment with anakinra combined with GCs to reduce the risk of relapse or GC exposure. Trial registration: ClinicalTrials.gov NCT02902731 giant cell arteritis anakinra glucocorticoids interleukin-1 quality of life Figures Figure 1 Figure 2 Figure 3 INTRODUCTION Giant cell arteritis (GCA) is the most common systemic vasculitis in patients over 50 years of age. The involvement of cranial vessels, especially branches of the external carotid, explains the cephalic symptoms or signs, especially headaches, scalp tenderness, or jaw claudication. Involvement of the ophthalmologic arteries can lead to bilateral blindness if left untreated [ 1 ]. Since the 1950s, glucocorticoids (GCs) have been the cornerstone of treatment and the best therapeutics for rapidly inducing disease remission [ 2 – 4 ]. However, during GC tapering, relapses are common and affect nearly half of patients [ 5 ]. Increasing the GC dose is often sufficient to control disease activity, but this leads to a subsequent increase in the duration of GC treatment. During the last two decades, many studies have indicated that important GC-related adverse events are observed in > 80% of patients, especially dependent on cumulative doses [ 6 – 8 ]. Therefore, many efforts have been made to identify new therapeutic options that may help better control disease activity and reduce GC exposure. The increase in knowledge about the GCA pathophysiology allows a better understanding of the central roles of inflammatory cytokines such as IL-1, IL-6, IL-17 or interferon-gamma, suggesting the possibility of targeted treatment [ 9 ]. Historically, methotrexate (MTX) has been used for a long time in GCA treatment, but studies have failed to demonstrate a sufficient GC-sparing effect, and recent studies have questioned the use of biologics to spare GCs [ 10 ]. Since the 2017 trial of tocilizumab demonstrated the possibility of reducing GC exposure by combining GCs with an anti-interleukin (IL)-6 receptor [ 11 ], the paradigm of GC-sparing strategies has become a priority in GCA treatment. In addition to Il-6, IL-1, especially IL-1beta, also appears to be a central inflammatory cytokine in the mechanism underlying GCA. High levels of IL-1beta were observed in the sera of GCA patients, as well as in the vessel wall of temporal artery biopsies (TAB). IL-1 secretion by monocytes/macrophages is an early occurrence in GCA pathogenesis and participates in the induction of the inflammatory cascade, leading to vascular damage [ 12 , 13 ]. Thus, there is a rationale for specifically inhibiting this cytokine. Anakinra (ANK) is an inhibitor of the IL-1 receptor (IL-1Ri) that is approved for the treatment of autoinflammatory diseases and Still’s disease. A previous small case series reported the efficacy of ANK in treating patients with relapsing GCA receiving reduced GC doses [ 14 , 15 ]. Thus, in this study (NCT02902731), we investigated whether the administration of anakinra for 4 months in combination with GCs would reduce the relapse rate compared with standard-of-care treatment with GCs alone. Owing to the SARS-CoV-2 pandemic, the study was prematurely discontinued by the sponsor because of initial uncertainties about patient outcomes under both conditions. However, we analyzed the available data for the 30 included patients. METHODS Study design and population This phase 3 study (NCT02902731) was a multicenter, randomized, double-blind, placebo-controlled trial conducted over a 52-week period. Each included patient approved the study and provided written consent. Patients with a new GCA diagnosis or with relapsing GCA lasting more than 6 months after discontinuation of any GCA-related treatment were eligible. To be included in this study, patients had to satisfy the three following criteria: 1) over 50 years of age; 2) demonstrated vasculitis on a TAB or on large-vessel imaging (PET/CT, aortic CT angiography or aortic MRA); and 3) started GC treatment less than 14 days before inclusion. Patients who previously received another immunosuppressant (e.g., methotrexate) or biologic were not included. Study protocol and endpoints The study protocol is shown in Figure 1. Patients who met the inclusion criteria and who provided written consent were randomized in a double-blinded manner into two groups. Patients in the anakinra group (ANK patients) received a daily subcutaneous injection of 100 mg of anakinra from inclusion to week 16 (W16). Patients in the placebo group (PBO patients) received a daily injection of placebo from inclusion to W16. In both arms, the GC protocol was similar. GC doses were calculated according to body weight (in mg/kg). Briefly, each included patient started on 0.7 mg/kg prednisone equivalent. Eventually, patients with ischemic complications might have received methylprednisolone pulses and a 1 mg/kg dose within the 14 days preceding inclusion. Week 0 was defined as inclusion in the study. According to the protocol schedule, the dose of prednisone in both arms was planned as follows: 0.5 mg/kg at W4, 0.3 at W8, 0.2 at W12, and 0.1 at W24. At W28, a 1 mg decrease every 4 weeks until discontinuation was planned. The study ended at W52. The primary endpoints were the relapse rate at W26 and the completion of protocolary GC tapering. At W26, patients should receive 0.1 mg/kg prednisone equivalent according to the study protocol. The secondary endpoints were as follows: - Analyze the relapse rates in both groups at different timeframes: between W0 and W16 (while receiving ANK or PBO injections), between W17 and W26, and between W27 and W52. - Compare the rate of first relapse in the two groups over the 52-week duration - Compare the GC doses in the two groups over the 52-week duration - Assess treatment tolerance in the two groups over the 52-week duration - Analyze the quality of life (QoL) of the patients via the 36-item short-form health survey questionnaire (SF-36) at W0, W16 and W52 and the health assessment questionnaire (HAQ) at different medical visits (W0, W4, W8, W12, W16, W26, W42 and W52). Relapse was defined as the reoccurrence of GCA or polymyalgia rheumatica (PMR) symptoms along with increased acute phase reactants in a patient who was previously in remission and who required a treatment increase. Before W26, relapses were treated with a 4-week increase in the GC dose at the previous threshold and then decreased following protocolary tapering. For patients with severe relapse (e.g., ischemic events), relapses occurring after W26 or relapses that did not respond to the 4-week increase in the GC dose at the previous threshold, treatment was allowed at the discretion of the responsible physician. Safety was assessed throughout the study, and adverse events (AEs) observed during each follow-up visit were retrieved. Serious AEs were defined as any undesirable medical occurrence that met any of the following criteria: resulted in death; was life-threatening; required an inpatient hospitalization (or a prolonged existing hospitalization); or resulted in significant disability. Sample size determination We initially hypothesized that the GCA relapse rate may decrease to 10% in ANK patients and remain at 40% in PBO patients. With a 5% bilateral alpha risk and an overall power of 80%, we estimated that 31 subjects in each group might be needed. In anticipation of patients with ANK discontinuation due to adverse events and patients lost to follow-up, we ultimately aimed to include 35 patients in each arm (i.e., a total of 70 patients). Premature study discontinuation The study started in April 2017, and the last patients were included in April 2021. Given the SARS-CoV-2 pandemic, the study was stopped prematurely, and 30 patients were included. We herein present the results of the intent-to-treat population of 30 patients. Statistical analyses Categorial variables are expressed as numbers (%), and quantitative variables are expressed as medians [interquartils 25–75]. Given the small sample size in both groups, Fisher’s exact test was used to compare categorical variables. Quantitative variables were analyzed via the Wilcoxon rank-sum test. Statistical analyses were computed with JMP 9.0.1 (SAS Institute Inc., Cary, NC). p < 0.05 was considered to indicate a statistically significant difference. RESULTS Study population Between 2017 and 2021, a total of 31 patients from 5 different centers were screened and randomized. One patient was prematurely excluded after randomization and did not receive treatment. The other 30 patients were randomized as follows: 17 in the ANK group and 13 in the PBO group. All the patients were included at GCA diagnosis, and none were included at relapse. Their characteristics are described and compared in Table 1. At baseline, no significant difference in those characteristics was observed between the two groups. Table 1. Characteristics at baseline of GCA patients who received anakinra or placebo Anakinra (n=17) Placebo (n=13) P Demographics Female 11 (65) 10 (77) 0.69 Age 70 [65–80] 77 [67–81] 0.44 Medical History Hypertension 11 (65) 8 (62) 1 Tobacco use 7 (41) 4 (31) 0.71 Hypercholesterolemia 5 (29) 4 (31) 1 Diabetes mellitus 3 (18) 0 0.24 Previous coronary disease or stroke 2 (12) 0 0.49 Clinical manifestations Body mass index, kg/m² 24.9 [22.24–30.58] 24.1 [21.36–26.51] 0.38 Fever 7 (41) 3 (23) 0.44 Headaches 14 (82) 10 (77) 1 Scalp tenderness 9 (53) 8 (62) 0.72 Jaw claudication 9 (53) 7 (54) 1 Abnormal temporal artery 7 (41) 5 (38) 1 Ophthalmologic signs 6 (35) 5 (38) 1 AION 2/6 (33) 1/5 (20) 1 CRAO 1/6 (17) 1/5 (20) 1 Blindness 0 3 (23) 0.07 Polymyalgia rheumatica 3 (18) 4 (31) 0.67 Vascular work-up Positive temporal artery biopsy 14/16 (88) 10/12 (83) 1 Positive ultrasonography 13/15 (87) 6/12 (50) 0.09 LVV on imaging 5/10 (50) 3/10 (30) 0.65 Laboratory tests C-reactive protein, mg/l 22 [6–61] 19 [6–42] 0.75 Fibrinogen, g/l 5.45 [4.1–7.6] 4.6 [3.6–6.9] 0.31 Erythrocyte sedimentation rate, mm 49 [26–85] 50 [32–86] 0.81 Hemoglobin, g/dl 10.6 [10.1–12.82] 11.7 [11.1–13.38] 0.26 Platelets, G/l 367 [288–489] 401 [335–453] 0.46 LDL-cholesterol, g/l 2.49 [2–3.2] 3.26 [2.1–4.1] 0.20 Total cholesterol, mmol/l 4.6 [3.99–5.18] 4.45 [3.84–6.35] 0.53 Triglycerid, g/l 1.29 [0.88–1.68] 1.15 [1.01–1.46] 0.71 Glucocorticoids starting dose, mg/day 50 [41–57] 52 [40—67] 0.93 Intravenous boli 4 (24) 1 (8) 0.35 The values are presented as numbers (%) or medians [IQRs 25–75]. AION: acute anterior ischemic optic neuropathy; CRAO: central retinal artery occlusion; LVV: large vessel vasculitis; LDL: low-density lipoprotein Among the 30 patients, 26 completed the protocolary visit at W52. Among the four other patients, one in the ANK arm was last observed at W42 and did not experience any relapse during follow-up. Two other patients, one each in the ANK and PBO arms, left the study at W20 after they experienced two relapses. The last patient in the ANK arm stopped the study at W16 after he experienced two relapses. Among the 17 patients who received ANK, one patient stopped treatment at W12 after he experienced serious AEs. He did not relapse before discontinuation. Efficacy endpoints Glucocorticoid management and outcomes are indicated in Table 2. Table 2. Glucocorticoid management and outcomes in GCA patients who received anakinra or placebo Anakinra (n=17) Placebo (n=13) p Glucocorticoid doses At inclusion 50 [41.5–57.5] 52.5 [40–67.5] 0.93 At W4 35 [28–41] 30 [25–40] 0.21 At W8 22 [17–25] 18 [15.5–24.5] 0.22 At W12 15 [12­–16] 12 [10–14] 0.17 At W16 11 [9–13] 9.5 [8–11.5] 0.18 At W20 10 [7.5–12] 8 [7–11.5] 0.33 At W26 9 [6–15] 6.5 [5–9] 0.09 At W36 6 [4.5–10] 5 [3.5–11] 0.42 At W42 5 [2.5–7.5] 3 [1–5] 0.13 At W52 2 [1.5–7] 2 [1–5] 0.69 Glucocorticoids discontinuation at W52 2 (14) 2 (17) 0.87 Protocolary GC decrease deviation at W52 12 (71) 8 (62) 0.71 Relapses W0-W52 9 (53) 6 (46) 1 W27 1 (7) 2 (15) 0.55 >1 relapse 3/9 (33) 2/6 (33) 1 The values are presented as numbers (%) or medians [IQRs 25–75]. At week 26, 12 (40%) patients had relapsed: 8 (47%) in the ANK group and 4 (31%) in the PBO group (p=0.47). No ischemic complications occurred at the time of relapse. The GC dose at W26 was 0.105 [0.08–0.32] mg/kg in the ANK group, whereas it was 0.098 [0.08–0.25] mg/kg in the PBO group (p=0.10). Deviation of protocolary GC tapering was observed in 13 (43%) patients, 7 (41%) in the ANK group and 6 (46%) in the PBO group (p=0.99). In 10 of these 13 patients, the GC dose was increased to control disease relapse. In the other 3 patients, GC tapering was slowed by the treating physician, although there was no clear evidence of relapse. At week 52, a total of 15 (50%) patients had relapsed: 9 (53%) in the ANK group and 6 (46%) in the PBO group (p=0.99). The relapse-free survival data are shown in Figure 2. Seven of the nine relapsing patients who received ANK experienced a disease flare after ANK discontinuation. The distribution of first relapses at the different timepoints was as follows: - Between W0 and W16, 2 (12%) patients relapsed in the ANK group, and 3 (23%) in the PBO group (p=0.63) - Between W17 and W26, 6 (35%) patients relapsed in the ANK group (including the one who stopped ANK at W12 for serious AEs) and 1 (8%) patient relapsed in the PBO group (p=0.10) - Between W27 and W52, 1 (7%) patient relapsed in the ANK group and 2 (15%) patients relapsed in the PBO group (p=0.55) The GC doses used in both groups at the different follow-up visits are shown in Table 2 and Figure 3 and were not different. At W52, GCs were discontinued in 2 (14%) patients in the ANK group and in 2 (17%) in the PBO group (p=0.87). Safety The adverse events observed during the study are noted in Table 3. No patient died during the follow-up. One patient stopped ANK prematurely at W12 because of a serious AE. Table 3. Adverse events observed in GCA patients who received anakinra or placebo Anakinra (n=17) Placebo (n=13) p Any serious adverse event 4 (24) 1 (8) 0.35 Muscular and skeletal 4 (24) 8 (62) 0.06 Cramp 0 3 (23) 0.07 Myopathy 2 (12) 2 (15) 1 Osteopenia 2 (12) 4 (31) 0.36 Fracture 1 (6) 2 (15) 0.56 Gastro-intestinal 5 (29) 4 (31) 1 Gastro-esophageal reflux 3 (18) 2 (15) 1 Epigastralgy 3 (18) 1 (8) 0.61 Constipation 1 (6) 1 (8) 1 Diarrhea 0 1 (8) 0.43 Neuropsychiatric 7 (41) 10 (77) 0.07 Asthenia 2 (12) 4 (31) 0.36 Psychiatric troubles 5 (29) 2 (15) 0.43 Anxiety 2 (12) 0 0.49 Insomnia 4 (24) 6 (46) 0.26 Infections 10 (59) 8 (62) 1 >1 infection 6 (35) 4 (31) 1 Bronchitis 5 (29) 4 (31) 1 Erysipelas 1 (6) 1 (8) 1 Sinusitis 0 1 (8) 0.43 Cystitis 4 (24) 0 0.11 Dental infections 1 (6) 3 (23) 0.29 Pharyngitis 2 (12) 2 (15) 1 Zoster reactivation 1 (6) 1 (8) 1 Cutaneous mycosis 1 (6) 0 1 Prostatitis 1 (6) 0 1 Pyelonephritis 1 (6) 0 1 Angina 1 (6) 0 0 Flu-like syndrome 1 (6) 1 (8) 1 SARS-CoV-2 infection 2 (12) 0 0.49 Decreased visual acuity 4 (24) 4 (31) 0.70 Headaches 4 (24) 5 (39) 0.44 Local cutaneous reaction 5 (29) 1 (8) 0.20 Weight gain 4 (24) 3 (23) 1 Hypercholesterolemia 1 (6) 0 1 Cytopenia 3 (18) 1 (8) 0.61 Thrombopenia 1 (6) 0 1 Anemia 2 (12) 0 0.49 Lymphopenia 1 (6) 0 1 Agranulocytosis 0 1 (8) 0.43 Increased gamma-GT 2 (12) 0 0.49 Cancer 1 (6) 1(8) 1 Epistaxis 2 (12) 1 (8) 1 Cardiovascular 2 (12) 3 (23) 0.63 Atrial fibrillation 0 2 (15) 0.18 Hypertension 2 (12) 1 (8) 1 Cutaneous 2 (12) 3 (23) 0.63 Frailty 0 1 (8) 0.43 Pruritis 2 (12) 0 0.49 Ecchymosis 0 2 (15) 0.18 Values are numbers (%) All the 30 patients experienced at least one AE. Seven serious AEs were reported by five patients, including 4 receiving ANK. The first patient in the ANK arm required two hospitalizations, one for hematemesis favored by thrombocytopenia and a second for arm erysipelas. He stopped ANK treatment at W12. The second patient received ANK and was hospitalized for a fall with a fracture. The third patient experienced two complicated urinary infections, one involving obstructive pyelonephritis and one involving nosocomial cystitis with multiresistant bacteria. ANK was stopped at the time of the second infection. The fourth patient was hospitalized due to COVID-19 infection, and ANK was stopped for several weeks. Finally, the fifth patient experienced agranulocytosis while receiving PBO. Infections were observed in 59% of the patients who received ANK and 62% of those who received PBO (p=0.99). Five (29%) patients receiving ANK experienced a cutaneous reaction after the injection. Assessment of quality of life The detailed SF-36 assessment results at baseline, at W16 and W52 are reported in Table 4. Table 4. SF-36 analysis in GCA patients who received anakinra or placebo Baseline Week 16 Week 52 P1 P2 SF-36 Physical functioning Anakinra 59.7 (30.3) 66.1 (31.2) 66.3 (19.8) 0.24 0.91 Placebo 54.2 (24.9) 54.6 (33.2) 53.1 (27.1) 0.97 0.74 Physical limitations Anakinra 32.4 (42.2) 71.4 (43.7) 39.6 (40.5) 0.02 0.15 Placebo 29.5 (40.0) 39.6 (39.1) 47.5 (46.3) 0.70 0.62 Emotional limitations Anakinra 50.98 (47.31) 66.67 (43.36) 47.22 (48.11) 0.07 0.65 Placebo 30.56 (43.71) 50 (43.81) 63.30 (48.30) 0.046 0.45 Energy Anakinra 46.47 (23.44) 50 (19.55) 47.92 (20.32) 0.79 0.90 Placebo 43.33 (16.0) 47.00 (15.13) 50 (14.34) 0.86 0.58 Emotional wellbeing Anakinra 61.88 (13.05) 69.50 (13.88) 65.67 (18.09) 0.04 0.89 Placebo 56.67 (18.09) 57.0 (16.72) 55.80 (18.24) 0.63 0.53 Social functioning Anakinra 69.85 (30.32) 76.25 (18.26) 68.54 (20.85) 0.55 0.98 Placebo 61.46 (20.96) 63.75 (17.30) 66.75 (12.25) 0.76 0.047 Pain Anakinra 50.88 (35.94) 66.79 (23.75) 67.29 (25.99) 0.30 0.95 Placebo 43.75 (31.34) 57.92 (24.79) 45.75 (16.07) 0.32 0.12 General health Anakinra 56.99 (11.67) 58.04 (11.35) 57.81 (11.96) 0.82 0.78 Placebo 61.98 (14.46) 62.50 (11.31) 61.88 (10.40) 0.87 0.68 The data are presented as means ± SD; bold, significant after Bonferroni correction. Paired t tests: P1: W16 compared to baseline, P2: W52 compared to W16. During the first 16 weeks, patients receiving ANK experienced significant improvements in terms of physical limitations and well-being. However, no significant difference in the general health assessment was observed among patients receiving ANK between W0 and W16. The HAQ score assessed at each medical visit did not significantly differ between the two treatment arms (Supplemental Table 1). DISCUSSION Recent advances in understanding GCA pathophysiology have suggested that targeting the IL-1 pathway may be an interesting therapeutic option for this disease. In addition, preliminary observations reported the possible efficacy of ANK in GCA [ 14 , 15 ]. Although prematurely discontinued, the present study did not show that adding four months of anakinra treatment to GCs at GCA onset reduced the risk of relapse. In both groups, half of the patients experienced at least one relapse. However, in patients who received ANK, most relapses (7/9) occurred after ANK discontinuation, which may indicate a suspensive effect. A deviation of the GC protocolary decrease was observed in two-thirds of the patients in both groups. Although patients receiving ANK described a significant improvement in the physical limitations and well-being components, a serious adverse event occurred in one quarter of them. Although the results of this study are negative, some important points should be discussed. First, since the study was prematurely discontinued, no definitive conclusion can be drawn. The small sample size did not allow us to show any differences between the two groups, and the data are shown only for descriptive purposes. Second, this therapeutic trial was designed before 2017, i.e before the GiACTA trial was published [ 11 ]. GC-sparing strategies were less established, and at that time, the standard-of-care treatment in France was to maintain GCs for at least 18 months. The present study aimed to analyze whether a 4-month prescription of ANK resulted in a reduction in the relapse rate and the discontinuation of GCs at W52, which was a significant endpoint. Therapeutic trials of new treatments for GCA are now designed differently to analyze the GC-sparing effects, especially with shorter GCs durations [ 16 – 18 ]. Unfortunately, the present study was not designed to assess the GC-sparing effect of ANK, and we cannot draw any strong conclusions regarding this point. However, 86% of the patients in the ANK arm were still receiving GCs at W52 and did not stop GCs. Third, although the relapse rate at W52 was not different between the groups, most relapses in the ANK group occurred after discontinuation of the biologic. This suspensive effect raises questions about the beneficial effect of prolonged use. In recent studies, the biologic has often been maintained for 12 months. Our study design may thus have contributed to the negative results observed. Finally, tolerance issues should be discussed. Only one patient receiving ANK stopped treatment because of an SAE that was probably directly linked to the treatment. All the other SAEs in the ANK group occurred after the treatment was stopped or lacked direct imputability. The most frequent adverse events in both groups were infections, the frequencies of which did not differ. This finding highlights the probable imputability of GCs. ANK injections are often painful or lead to local reactions, which were observed in 29% of involved patients. CONCLUSIONS This multicenter, randomized, double-blind, placebo-controlled trial of anakinra in the treatment of giant cell arteritis was prematurely discontinued. However, the intent-to-treat analysis of the 30 included patients failed to demonstrate a beneficial effect of anakinra in reducing the risk of relapse or GC exposure. The present study does not support the use of anakinra for 4 months at the time of diagnosis in GCA patients. Abbreviations AEs: adverse events ANK: anakinra CT: computed tomography GCs: glucocorticoids GCA: giant cell arteritis HAQ: health assessment questionnaire IL: interleukin MRA: magnetic resonance angiography MTX: methotrexate PBO: placebo PET/CT: positron emission tomography coupled with computed tomography PMR: polymyalgia rheumatica QoL: quality of life SF36: short form Declarations Ethics approval and consent to participate Written informed consent was obtained from all participating patients. Consent for publication Not applicable Availability of data and materials The data are available upon reasonable request to the corresponding author. Competing interests Hubert de Boysson reports receiving fees for serving on advisory boards from Roche-Chugai and Novartis and lecture fees from Roche-Chugai, Novartis, Fresenius Kabi, GlaxoSmithKline, Amicus therapeutics, and Sanofi. Funding This study was funded by the French PHRC (Protocole Hospitalier de Recherche Clinique) program. Authors' contributions HdB, KHL, LG, TQ, EL, HB, NLG, AlA, AD, SD, JB, GM, NMS, AS, BLM, GP, JJP and AcA acquired the data and were involved in the interpretation of the results and in the review of the manuscript. HdB, AS, JJP and AcA designed the study. HdB and AcA wrote the first draft of the manuscript, which was read, corrected and approved by all the authors. Acknowledgements Not applicable References Salvarani C, Cantini F, Hunder GG. Polymyalgia rheumatica and giant-cell arteritis. Lancet. 2008;372:234-45. Shick RM, Baggenstoss AH, Fuller BF, Polley HF. Effects of cortisone and ACTH on periarteritis nodosa and cranial arteritis. Proc Staff Meet Mayo Clin. 1950;25:492-4. Hellmich B, Agueda A, Monti S, Buttgereit F, de Boysson H, Brouwer E, et al. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020;79:19-30. Maz M, Chung SA, Abril A, Langford CA, Gorelik M, Guyatt G, et al. 2021 American college of rheumatology/vasculitis foundation guideline for the management of giant cell arteritis and takayasu arteritis. Arthritis Rheumatol. 2021;73:1349-65. Mainbourg S, Addario A, Samson M, Puechal X, Francois M, Durupt S, et al. Prevalence of giant cell arteritis relapse in patients treated with glucocorticoids: a meta-analysis. Arthritis Care Res (Hoboken). 2020;72:838-49. Proven A, Gabriel SE, Orces C, O'Fallon WM, Hunder GG. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003;49:703-8. Broder MS, Sarsour K, Chang E, Collinson N, Tuckwell K, Napalkov P, et al. Corticosteroid-related adverse events in patients with giant cell arteritis: a claims-based analysis. Semin Arthritis Rheum. 2016;46:246-52. Castan P, Dumont A, Deshayes S, Boutemy J, Martin Silva N, Maigne G, et al. Impact of glucocorticoid cumulative doses in a real-life cohort of patients affected by giant cell arteritis. J Clin Med. 2022;11:1034. Samson M, Corbera-Bellalta M, Audia S, Planas-Rigol E, Martin L, Cid MC, et al. Recent advances in our understanding of giant cell arteritis pathogenesis. Autoimmun Rev. 2017;16:833-44. Mahr AD, Jover JA, Spiera RF, Hernandez-Garcia C, Fernandez-Gutierrez B, Lavalley MP, et al. Adjunctive methotrexate for treatment of giant cell arteritis: an individual patient data meta-analysis. Arthritis Rheum. 2007;56:2789-97. Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, et al. Trial of tocilizumab in giant-cell arteritis. N Engl J Med. 2017;377:317-28. Pountain G, Hazleman B, Cawston TE. Circulating levels of IL-1beta, IL-6 and soluble IL-2 receptor in polymyalgia rheumatica and giant cell arteritis and rheumatoid arthritis. Br J Rheumatol. 1998;37:797-8. Schett G, Dayer JM, Manger B. Interleukin-1 function and role in rheumatic disease. Nat Rev Rheumatol. 2016;12:14-24. Ly KH, Stirnemann J, Liozon E, Michel M, Fain O, Fauchais AL. Interleukin-1 blockade in refractory giant cell arteritis. Joint Bone Spine. 2014;81:76-8. Deshayes S, Ly KH, Rieu V, Maigne G, Martin Silva N, Manrique A, et al. Steroid-sparing effect of anakinra in giant-cell arteritis: a case series with clinical, biological and iconographic long-term assessments. Rheumatology (Oxford). 2021;61:400-6. Langford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, et al. A randomized, double-blind trial of abatacept (CTLA-4Ig) for the treatment of giant cell arteritis. Arthritis Rheumatol. 2017;69:837-45. Venhoff N, Schmidt WA, Bergner R, Rech J, Unger L, Tony HP, et al. Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2023;5:e341-50. Conway R, O'Neill L, Gallagher P, McCarthy GM, Murphy CC, Veale DJ, et al. Ustekinumab for refractory giant cell arteritis: A prospective 52-week trial. Semin Arthritis Rheum. 2018;48:523-8. Additional Declarations Competing interest reported. Hubert de Boysson reports receiving fees for serving on advisory boards from Roche-Chugai and Novartis and lecture fees from Roche-Chugai, Novartis, Fresenius Kabi, GlaxoSmithKline, Amicus therapeutics, and Sanofi. Cite Share Download PDF Status: Published Journal Publication published 07 Jun, 2025 Read the published version in Arthritis Research & Therapy → Version 1 posted Editorial decision: Revision requested 10 Dec, 2024 Reviews received at journal 10 Dec, 2024 Reviews received at journal 23 Nov, 2024 Reviews received at journal 17 Nov, 2024 Reviewers agreed at journal 08 Nov, 2024 Reviewers agreed at journal 06 Nov, 2024 Reviewers agreed at journal 05 Nov, 2024 Reviewers invited by journal 05 Nov, 2024 Editor assigned by journal 11 Oct, 2024 Submission checks completed at journal 11 Oct, 2024 First submitted to journal 09 Oct, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5231536","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":364836984,"identity":"c237cc5c-dcf8-4bf3-883e-dee469cf489f","order_by":0,"name":"Hubert de 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Normandie","correspondingAuthor":false,"prefix":"","firstName":"Jean-Jacques","middleName":"","lastName":"Parienti","suffix":""},{"id":364837001,"identity":"a95ed0e0-40e9-47a1-8f3f-4643546772b0","order_by":17,"name":"Achille Aouba","email":"","orcid":"","institution":"Caen University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Achille","middleName":"","lastName":"Aouba","suffix":""}],"badges":[],"createdAt":"2024-10-09 10:08:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5231536/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5231536/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13075-025-03493-z","type":"published","date":"2025-06-07T15:57:16+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":67263887,"identity":"2d299b51-2b2a-4468-bee5-da794d667290","added_by":"auto","created_at":"2024-10-23 06:28:12","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":132142,"visible":true,"origin":"","legend":"\u003cp\u003eStudy protocol.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-5231536/v1/908a05c3be8f627636e171c7.png"},{"id":67263888,"identity":"8902ce23-2db9-4550-9da0-1a44157fd580","added_by":"auto","created_at":"2024-10-23 06:28:12","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":136906,"visible":true,"origin":"","legend":"\u003cp\u003eRelapse-free survival of patients receiving anakinra or placebo.\u003c/p\u003e","description":"","filename":"Onlinefloatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-5231536/v1/badc85237319566c86b1f910.png"},{"id":67263889,"identity":"6e1d4d82-b74d-4296-a6d6-6acdf62f7b59","added_by":"auto","created_at":"2024-10-23 06:28:12","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":183668,"visible":true,"origin":"","legend":"\u003cp\u003eMean prednisone doses in patients receiving anakinra or placebo over a 52-week duration\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-5231536/v1/8216cd8a22da96e03e2e3b4a.png"},{"id":84242521,"identity":"39e4a22a-b306-4604-9bd0-4cabe31a6986","added_by":"auto","created_at":"2025-06-09 16:09:00","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1810126,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5231536/v1/a4a51531-758c-489c-9b82-10595b929520.pdf"}],"financialInterests":"Competing interest reported. Hubert de Boysson reports receiving fees for serving on advisory boards from Roche-Chugai and Novartis and lecture fees from Roche-Chugai, Novartis, Fresenius Kabi, GlaxoSmithKline, Amicus therapeutics, and Sanofi.","formattedTitle":"Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eGiant cell arteritis (GCA) is the most common systemic vasculitis in patients over 50 years of age. The involvement of cranial vessels, especially branches of the external carotid, explains the cephalic symptoms or signs, especially headaches, scalp tenderness, or jaw claudication. Involvement of the ophthalmologic arteries can lead to bilateral blindness if left untreated [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Since the 1950s, glucocorticoids (GCs) have been the cornerstone of treatment and the best therapeutics for rapidly inducing disease remission [\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. However, during GC tapering, relapses are common and affect nearly half of patients [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Increasing the GC dose is often sufficient to control disease activity, but this leads to a subsequent increase in the duration of GC treatment. During the last two decades, many studies have indicated that important GC-related adverse events are observed in \u0026gt;\u0026thinsp;80% of patients, especially dependent on cumulative doses [\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Therefore, many efforts have been made to identify new therapeutic options that may help better control disease activity and reduce GC exposure. The increase in knowledge about the GCA pathophysiology allows a better understanding of the central roles of inflammatory cytokines such as IL-1, IL-6, IL-17 or interferon-gamma, suggesting the possibility of targeted treatment [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Historically, methotrexate (MTX) has been used for a long time in GCA treatment, but studies have failed to demonstrate a sufficient GC-sparing effect, and recent studies have questioned the use of biologics to spare GCs [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Since the 2017 trial of tocilizumab demonstrated the possibility of reducing GC exposure by combining GCs with an anti-interleukin (IL)-6 receptor [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], the paradigm of GC-sparing strategies has become a priority in GCA treatment. In addition to Il-6, IL-1, especially IL-1beta, also appears to be a central inflammatory cytokine in the mechanism underlying GCA. High levels of IL-1beta were observed in the sera of GCA patients, as well as in the vessel wall of temporal artery biopsies (TAB). IL-1 secretion by monocytes/macrophages is an early occurrence in GCA pathogenesis and participates in the induction of the inflammatory cascade, leading to vascular damage [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Thus, there is a rationale for specifically inhibiting this cytokine.\u003c/p\u003e \u003cp\u003eAnakinra (ANK) is an inhibitor of the IL-1 receptor (IL-1Ri) that is approved for the treatment of autoinflammatory diseases and Still\u0026rsquo;s disease. A previous small case series reported the efficacy of ANK in treating patients with relapsing GCA receiving reduced GC doses [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Thus, in this study (NCT02902731), we investigated whether the administration of anakinra for 4 months in combination with GCs would reduce the relapse rate compared with standard-of-care treatment with GCs alone. Owing to the SARS-CoV-2 pandemic, the study was prematurely discontinued by the sponsor because of initial uncertainties about patient outcomes under both conditions. However, we analyzed the available data for the 30 included patients.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cstrong\u003eStudy design and population\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis phase 3 study (NCT02902731) was a multicenter, randomized, double-blind, placebo-controlled trial conducted\u0026nbsp;over\u0026nbsp;a 52-week period. Each included patient approved the study and\u0026nbsp;provided\u0026nbsp;written consent.\u003c/p\u003e\n\u003cp\u003ePatients with a new GCA diagnosis or with relapsing GCA lasting more than 6 months after discontinuation of any GCA-related treatment were eligible. To be included in this study, patients had to satisfy the three following criteria: 1) over 50 years\u0026nbsp;of age; 2)\u0026nbsp;demonstrated\u0026nbsp;vasculitis on a TAB or on large-vessel imaging (PET/CT, aortic CT angiography or aortic MRA); and 3) started GC treatment less than 14 days before inclusion.\u003c/p\u003e\n\u003cp\u003ePatients who previously received another immunosuppressant (e.g., methotrexate) or biologic were not included.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy protocol and endpoints\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study\u0026nbsp;protocol is shown in Figure 1. Patients who met the inclusion criteria and who\u0026nbsp;provided\u0026nbsp;written consent were randomized in a double-blinded manner into two groups. Patients in the anakinra group (ANK patients) received a daily subcutaneous injection of 100 mg of anakinra from inclusion to week 16 (W16). Patients in the placebo group (PBO patients) received a daily injection of placebo from inclusion to W16.\u003c/p\u003e\n\u003cp\u003eIn both arms, the GC protocol was similar. GC doses were calculated according to body weight (in mg/kg). Briefly, each included patient started on 0.7 mg/kg prednisone equivalent. Eventually, patients with ischemic complications might have received methylprednisolone pulses and a 1 mg/kg dose within the 14 days preceding inclusion. Week 0 was defined as inclusion in the study. According to the protocol schedule, the dose of prednisone in both arms was planned as follows: 0.5 mg/kg at W4, 0.3 at W8, 0.2 at W12, and 0.1 at W24. At W28, a 1 mg decrease every 4 weeks until discontinuation was planned.\u003c/p\u003e\n\u003cp\u003eThe study ended at W52.\u003c/p\u003e\n\u003cp\u003eThe primary\u0026nbsp;endpoints were\u0026nbsp;the relapse rate at W26 and the completion of protocolary GC tapering. At W26, patients should\u0026nbsp;receive\u0026nbsp;0.1 mg/kg prednisone equivalent according to the study protocol.\u003c/p\u003e\n\u003cp\u003eThe secondary endpoints were\u0026nbsp;as follows:\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Analyze the relapse rates in both groups at different timeframes: between W0 and W16 (while receiving ANK or PBO injections), between W17 and W26, and between W27 and W52.\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Compare the rate of first relapse in the two groups over the 52-week duration\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Compare the GC doses in the two groups over the 52-week duration\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Assess treatment tolerance in the two groups over the 52-week duration\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Analyze the quality of life (QoL) of the patients via the 36-item short-form health survey questionnaire (SF-36) at W0, W16 and W52 and the health assessment questionnaire (HAQ) at different medical visits (W0, W4, W8, W12, W16, W26, W42 and W52).\u003c/p\u003e\n\u003cp\u003eRelapse was defined as the reoccurrence of GCA or polymyalgia rheumatica (PMR) symptoms along with increased acute phase reactants in a patient who was previously in remission and who required a treatment increase.\u003c/p\u003e\n\u003cp\u003eBefore W26, relapses were treated with a 4-week increase\u0026nbsp;in the\u0026nbsp;GC dose at the previous threshold\u0026nbsp;and\u0026nbsp;then decreased following protocolary tapering. For patients with severe relapse (e.g.,\u0026nbsp;ischemic\u0026nbsp;events), relapses occurring after W26 or relapses that did not respond to the 4-week increase\u0026nbsp;in the\u0026nbsp;GC dose at the previous threshold, treatment was\u0026nbsp;allowed\u0026nbsp;at the discretion of the responsible physician.\u003c/p\u003e\n\u003cp\u003eSafety was assessed throughout the study,\u0026nbsp;and adverse events (AEs) observed during each follow-up visit were retrieved. Serious AEs were defined as any undesirable medical occurrence that met any of the following criteria: resulted in death; was life-threatening; required an inpatient hospitalization (or a prolonged existing hospitalization); or resulted in significant disability.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size determination\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe initially hypothesized that the GCA relapse rate may decrease to 10% in ANK patients and remain at 40% in PBO patients. With a 5% bilateral alpha risk and an overall power of 80%, we estimated that 31 subjects in each group might be needed. In anticipation of patients with ANK discontinuation due to adverse events and patients lost to follow-up, we ultimately aimed to include 35 patients in each arm (i.e., a total of 70 patients).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePremature study discontinuation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study started in April 2017,\u0026nbsp;and the last patients\u0026nbsp;were\u0026nbsp;included in April 2021. Given the SARS-CoV-2 pandemic, the study was stopped prematurely, and\u0026nbsp;30 patients were included. We herein present the results of the intent-to-treat population of 30 patients.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analyses\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCategorial variables\u0026nbsp;are\u0026nbsp;expressed as\u0026nbsp;numbers\u0026nbsp;(%),\u0026nbsp;and quantitative variables\u0026nbsp;are expressed as medians [interquartils 25\u0026ndash;75]. Given the small sample\u0026nbsp;size\u0026nbsp;in both groups,\u0026nbsp;Fisher\u0026rsquo;s\u0026nbsp;exact test was used to compare\u0026nbsp;categorical\u0026nbsp;variables. Quantitative variables were analyzed\u0026nbsp;via the\u0026nbsp;Wilcoxon rank-sum test.\u003c/p\u003e\n\u003cp\u003eStatistical analyses were computed with JMP 9.0.1 (SAS Institute Inc., Cary, NC). p\u003cu\u003e\u0026lt;\u003c/u\u003e0.05 was considered to indicate a statistically significant difference.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy population\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBetween 2017 and 2021, a total of 31 patients from 5 different centers were screened and randomized. One patient was prematurely excluded after randomization and did not receive treatment. The other 30 patients were randomized as follows: 17 in the ANK group and 13 in the PBO group. All the patients were included at GCA diagnosis,\u0026nbsp;and none\u0026nbsp;were included\u0026nbsp;at relapse. Their characteristics are described and compared in Table 1. At baseline, no significant difference in those characteristics was observed between the two groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1.\u0026nbsp;\u003c/strong\u003eCharacteristics at baseline of GCA patients who received anakinra or placebo\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"634\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra (n=17)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo (n=13)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDemographics\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e11 (65)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e10 (77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.69\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e70 [65\u0026ndash;80]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e77 [67\u0026ndash;81]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.44\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMedical History\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eHypertension\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e11 (65)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e8 (62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eTobacco use\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e7 (41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.71\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eHypercholesterolemia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e5 (29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eDiabetes mellitus\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e3 (18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.24\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003ePrevious coronary disease or stroke\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eClinical manifestations\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eBody mass index, kg/m\u0026sup2;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e24.9 [22.24\u0026ndash;30.58]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e24.1 [21.36\u0026ndash;26.51]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.38\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eFever\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e7 (41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.44\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eHeadaches\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e14 (82)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e10 (77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eScalp tenderness\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e9 (53)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e8 (62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.72\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eJaw claudication\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e9 (53)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e7 (54)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eAbnormal temporal artery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e7 (41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e5 (38)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eOphthalmologic signs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e6 (35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e5 (38)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cem\u003eAION\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e2/6 (33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e1/5 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cem\u003eCRAO\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e1/6 (17)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e1/5 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cem\u003eBlindness\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003ePolymyalgia rheumatica\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e3 (18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.67\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVascular work-up\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003ePositive temporal artery biopsy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e14/16 (88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e10/12 (83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003ePositive ultrasonography\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e13/15 (87)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e6/12 (50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.09\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eLVV on imaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e5/10 (50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e3/10 (30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.65\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eLaboratory tests\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eC-reactive protein, mg/l\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e22 [6\u0026ndash;61]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e19 [6\u0026ndash;42]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.75\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eFibrinogen, g/l\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e5.45 [4.1\u0026ndash;7.6]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e4.6 [3.6\u0026ndash;6.9]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.31\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eErythrocyte sedimentation rate, mm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e49 [26\u0026ndash;85]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e50 [32\u0026ndash;86]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.81\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eHemoglobin, g/dl\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e10.6 [10.1\u0026ndash;12.82]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e11.7 [11.1\u0026ndash;13.38]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003ePlatelets, G/l\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e367 [288\u0026ndash;489]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e401 [335\u0026ndash;453]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.46\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eLDL-cholesterol, g/l\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e2.49 [2\u0026ndash;3.2]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e3.26 [2.1\u0026ndash;4.1]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.20\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eTotal cholesterol, mmol/l\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e4.6 [3.99\u0026ndash;5.18]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e4.45 [3.84\u0026ndash;6.35]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.53\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eTriglycerid, g/l\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e1.29 [0.88\u0026ndash;1.68]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e1.15 [1.01\u0026ndash;1.46]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.71\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGlucocorticoids starting dose, mg/day\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e50 [41\u0026ndash;57]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e52 [40\u0026mdash;67]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.93\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 43.2859%;\"\u003e\n \u003cp\u003eIntravenous boli\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 23.8547%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.00474%;\"\u003e\n \u003cp\u003e0.35\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe values are presented as numbers (%) or medians [IQRs 25\u0026ndash;75]. AION: acute anterior ischemic optic neuropathy; CRAO: central retinal artery occlusion; LVV: large vessel vasculitis; LDL: low-density lipoprotein\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAmong\u0026nbsp;the 30 patients, 26 completed the protocolary visit at W52. Among the four other patients, one in the ANK arm was last\u0026nbsp;observed\u0026nbsp;at W42 and did not experience any relapse during follow-up. Two other patients, one each in the ANK and PBO arms,\u0026nbsp;left the study at W20 after they experienced two relapses. The last patient in the ANK arm stopped the study at W16 after he experienced two relapses.\u003c/p\u003e\n\u003cp\u003eAmong the 17 patients who received ANK, one patient stopped treatment at W12 after he experienced serious AEs. He did not relapse before discontinuation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEfficacy endpoints\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGlucocorticoid\u0026nbsp;management and outcomes are indicated in Table 2.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2.\u0026nbsp;\u003c/strong\u003eGlucocorticoid\u0026nbsp;management and outcomes in GCA patients who received anakinra or placebo\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"738\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra (n=17)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo (n=13)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGlucocorticoid doses\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt inclusion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e50 [41.5\u0026ndash;57.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e52.5 [40\u0026ndash;67.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.93\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e35 [28\u0026ndash;41]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e30 [25\u0026ndash;40]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.21\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e22 [17\u0026ndash;25]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e18 [15.5\u0026ndash;24.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.22\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e15 [12\u0026shy;\u0026ndash;16]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e12 [10\u0026ndash;14]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.17\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e11 [9\u0026ndash;13]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e9.5 [8\u0026ndash;11.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.18\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e10 [7.5\u0026ndash;12]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e8 [7\u0026ndash;11.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.33\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e9 [6\u0026ndash;15]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e6.5 [5\u0026ndash;9]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.09\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e6 [4.5\u0026ndash;10]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e5 [3.5\u0026ndash;11]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.42\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W42\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e5 [2.5\u0026ndash;7.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e3 [1\u0026ndash;5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.13\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eAt W52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e2 [1.5\u0026ndash;7]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e2 [1\u0026ndash;5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.69\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGlucocorticoids discontinuation at W52\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e2 (14)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e2 (17)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.87\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eProtocolary GC decrease deviation at W52\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e12 (71)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e8 (62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.71\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRelapses\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eW0-W52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e9 (53)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e6 (46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u003cu\u003e\u0026lt;\u003c/u\u003e W16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.63\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003eW17-W26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e6 (35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u003cu\u003e\u0026gt;\u003c/u\u003eW27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e1 (7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e0.55\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.4824%;\"\u003e\n \u003cp\u003e\u0026gt;1 relapse\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.9648%;\"\u003e\n \u003cp\u003e3/9 (33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8293%;\"\u003e\n \u003cp\u003e2/6 (33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7.72358%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe values\u0026nbsp;are\u0026nbsp;presented as\u0026nbsp;numbers (%) or medians [IQRs 25\u0026ndash;75].\u003c/p\u003e\n\u003cp\u003eAt week 26, 12 (40%) patients had relapsed:\u0026nbsp;8 (47%) in the ANK group\u0026nbsp;and\u0026nbsp;4 (31%) in the PBO group (p=0.47). No\u0026nbsp;ischemic complications\u0026nbsp;occurred at the time of relapse.\u0026nbsp;The\u0026nbsp;GC\u0026nbsp;dose\u0026nbsp;at W26\u0026nbsp;was\u0026nbsp;0.105 [0.08\u0026ndash;0.32] mg/kg in the ANK group,\u0026nbsp;whereas it was\u0026nbsp;0.098 [0.08\u0026ndash;0.25] mg/kg in the PBO group (p=0.10).\u0026nbsp;Deviation of\u0026nbsp;protocolary GC tapering was observed in 13 (43%) patients, 7 (41%) in the ANK group and 6 (46%) in the PBO group (p=0.99). In 10 of these 13 patients,\u0026nbsp;the\u0026nbsp;GC dose was increased to control disease relapse. In the other\u0026nbsp;3\u0026nbsp;patients, GC tapering was\u0026nbsp;slowed\u0026nbsp;by the treating physician,\u0026nbsp;although there was no clear evidence of relapse.\u003c/p\u003e\n\u003cp\u003eAt week 52, a total of 15 (50%) patients had relapsed:\u0026nbsp;9 (53%) in the ANK group and 6 (46%) in the PBO group (p=0.99). The relapse-free survival\u0026nbsp;data are\u0026nbsp;shown in Figure 2. Seven of the nine relapsing patients who received ANK experienced a disease flare after ANK discontinuation.\u003c/p\u003e\n\u003cp\u003eThe distribution of first relapses at the different timepoints was as follows:\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Between W0 and W16, 2 (12%) patients relapsed in the ANK group, and 3 (23%) in the PBO group (p=0.63)\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Between W17 and W26, 6 (35%) patients relapsed in the ANK group (including the one who stopped ANK at W12 for serious AEs) and 1 (8%) patient relapsed in the PBO group (p=0.10)\u003c/p\u003e\n\u003cp\u003e- \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Between W27 and W52, 1 (7%) patient relapsed in the ANK group and 2 (15%) patients relapsed in the PBO group (p=0.55)\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;GC doses\u0026nbsp;used\u0026nbsp;in both groups at the different follow-up visits are shown in Table 2 and Figure 3 and were not different. At W52,\u0026nbsp;GCs\u0026nbsp;were discontinued in 2 (14%) patients in the ANK group and in 2 (17%) in the PBO group (p=0.87).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSafety\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe adverse events observed during the study are noted in Table 3. No patient died during the follow-up. One patient stopped ANK prematurely at W12 because of a serious AE.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3.\u0026nbsp;\u003c/strong\u003eAdverse events observed in GCA patients who received anakinra or placebo\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"709\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra (n=17)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo (n=13)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAny serious adverse event\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.35\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMuscular and skeletal\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e8 (62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.06\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eCramp\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eMyopathy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eOsteopenia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.36\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eFracture\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.56\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGastro-intestinal\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e5 (29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eGastro-esophageal reflux\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e3 (18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eEpigastralgy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e3 (18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.61\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eConstipation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eDiarrhea\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNeuropsychiatric\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e7 (41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e10 (77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eAsthenia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.36\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003ePsychiatric troubles\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e5 (29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eAnxiety\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eInsomnia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e6 (46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eInfections\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e10 (59)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e8 (62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u0026gt;1 infection\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e6 (35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eBronchitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e5 (29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eErysipelas\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eSinusitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eCystitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.11\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eDental infections\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.29\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003ePharyngitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eZoster reactivation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eCutaneous mycosis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eProstatitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003ePyelonephritis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eAngina\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eFlu-like syndrome\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eSARS-CoV-2 infection\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDecreased visual acuity\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e4 (31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.70\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eHeadaches\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e5 (39)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.44\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eLocal cutaneous reaction\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e5 (29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.20\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWeight gain\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e4 (24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eHypercholesterolemia\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCytopenia\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e3 (18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.61\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eThrombopenia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eAnemia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eLymphopenia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eAgranulocytosis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIncreased gamma-GT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCancer\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e1 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1(8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEpistaxis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCardiovascular\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.63\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eAtrial fibrillation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.18\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eHypertension\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCutaneous\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e3 (23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.63\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eFrailty\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e1 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003ePruritis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e2 (12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.9661%;\"\u003e\n \u003cp\u003eEcchymosis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0677%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.9267%;\"\u003e\n \u003cp\u003e2 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.03949%;\"\u003e\n \u003cp\u003e0.18\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eValues are numbers (%)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll the 30 patients experienced at least one AE. Seven serious AEs were reported by five patients, including 4 receiving ANK. The first patient in the ANK arm required two hospitalizations, one for hematemesis favored by thrombocytopenia\u0026nbsp;and\u0026nbsp;a second for arm erysipelas. He stopped ANK treatment at W12. The second patient\u0026nbsp;received\u0026nbsp;ANK and was hospitalized for a fall with a fracture. The third patient experienced two complicated urinary infections, one\u0026nbsp;involving\u0026nbsp;obstructive pyelonephritis and one\u0026nbsp;involving\u0026nbsp;nosocomial cystitis with multiresistant bacteria. ANK was stopped at the time of the second infection. The fourth patient was hospitalized due to COVID-19\u0026nbsp;infection, and\u0026nbsp;ANK was stopped for\u0026nbsp;several\u0026nbsp;weeks. Finally, the fifth patient experienced agranulocytosis while receiving PBO.\u003c/p\u003e\n\u003cp\u003eInfections were observed in 59% of the patients who received ANK and 62% of those who received PBO (p=0.99).\u003c/p\u003e\n\u003cp\u003eFive (29%) patients receiving ANK experienced a cutaneous reaction after the injection.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAssessment of quality of life\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe detailed SF-36 assessment results at baseline, at W16 and W52 are reported in Table 4.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 4.\u0026nbsp;\u003c/strong\u003eSF-36 analysis in GCA patients who received anakinra or placebo\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"603\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBaseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWeek 16\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWeek 52\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSF-36\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePhysical functioning\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e59.7 (30.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e66.1 (31.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e66.3 (19.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.91\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e54.2 (24.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e54.6 (33.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e53.1 (27.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.97\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.74\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePhysical limitations\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e32.4 (42.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e71.4 (43.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e39.6 (40.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.02\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.15\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e29.5 (40.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e39.6 (39.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e47.5 (46.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.62\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmotional limitations\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e50.98 (47.31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e66.67 (43.36)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e47.22 (48.11)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.65\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e30.56 (43.71)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e50 (43.81)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e63.30 (48.30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.046\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.45\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnergy\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e46.47 (23.44)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e50 (19.55)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e47.92 (20.32)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.90\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e43.33 (16.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e47.00 (15.13)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e50 (14.34)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.86\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.58\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmotional wellbeing\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e61.88 (13.05)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e69.50 (13.88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e65.67 (18.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.04\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.89\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e56.67 (18.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e57.0 (16.72)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e55.80 (18.24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.53\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSocial functioning\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e69.85 (30.32)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e76.25 (18.26)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e68.54 (20.85)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.55\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.98\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e61.46 (20.96)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e63.75 (17.30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e66.75 (12.25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.76\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.047\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePain\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e50.88 (35.94)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e66.79 (23.75)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e67.29 (25.99)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.95\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e43.75 (31.34)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e57.92 (24.79)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e45.75 (16.07)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.12\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGeneral health\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnakinra\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e56.99 (11.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e58.04 (11.35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e57.81 (11.96)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.82\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.78\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 28.0992%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.3967%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e61.98 (14.46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e62.50 (11.31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e61.88 (10.40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.87\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11.9008%;\"\u003e\n \u003cp\u003e0.68\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe data are presented as means \u0026plusmn; SD; bold, significant after Bonferroni correction.\u003c/p\u003e\n\u003cp\u003ePaired t tests: P1: W16 compared to baseline, P2: W52 compared to W16.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring the first 16 weeks, patients receiving ANK experienced significant\u0026nbsp;improvements in terms of\u0026nbsp;physical limitations and well-being. However, no significant difference in the general health assessment was observed among patients receiving ANK between W0 and W16.\u003c/p\u003e\n\u003cp\u003eThe HAQ score assessed at each medical visit did not significantly differ between the two treatment arms (Supplemental Table 1).\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eRecent advances in understanding GCA pathophysiology have suggested that targeting the IL-1 pathway may be an interesting therapeutic option for this disease. In addition, preliminary observations reported the possible efficacy of ANK in GCA [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Although prematurely discontinued, the present study did not show that adding four months of anakinra treatment to GCs at GCA onset reduced the risk of relapse. In both groups, half of the patients experienced at least one relapse. However, in patients who received ANK, most relapses (7/9) occurred after ANK discontinuation, which may indicate a suspensive effect. A deviation of the GC protocolary decrease was observed in two-thirds of the patients in both groups. Although patients receiving ANK described a significant improvement in the physical limitations and well-being components, a serious adverse event occurred in one quarter of them.\u003c/p\u003e \u003cp\u003eAlthough the results of this study are negative, some important points should be discussed.\u003c/p\u003e \u003cp\u003eFirst, since the study was prematurely discontinued, no definitive conclusion can be drawn. The small sample size did not allow us to show any differences between the two groups, and the data are shown only for descriptive purposes.\u003c/p\u003e \u003cp\u003eSecond, this therapeutic trial was designed before 2017, i.e before the GiACTA trial was published [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. GC-sparing strategies were less established, and at that time, the standard-of-care treatment in France was to maintain GCs for at least 18 months. The present study aimed to analyze whether a 4-month prescription of ANK resulted in a reduction in the relapse rate and the discontinuation of GCs at W52, which was a significant endpoint.\u003c/p\u003e \u003cp\u003eTherapeutic trials of new treatments for GCA are now designed differently to analyze the GC-sparing effects, especially with shorter GCs durations [\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Unfortunately, the present study was not designed to assess the GC-sparing effect of ANK, and we cannot draw any strong conclusions regarding this point. However, 86% of the patients in the ANK arm were still receiving GCs at W52 and did not stop GCs.\u003c/p\u003e \u003cp\u003eThird, although the relapse rate at W52 was not different between the groups, most relapses in the ANK group occurred after discontinuation of the biologic. This suspensive effect raises questions about the beneficial effect of prolonged use. In recent studies, the biologic has often been maintained for 12 months. Our study design may thus have contributed to the negative results observed.\u003c/p\u003e \u003cp\u003eFinally, tolerance issues should be discussed. Only one patient receiving ANK stopped treatment because of an SAE that was probably directly linked to the treatment. All the other SAEs in the ANK group occurred after the treatment was stopped or lacked direct imputability. The most frequent adverse events in both groups were infections, the frequencies of which did not differ. This finding highlights the probable imputability of GCs. ANK injections are often painful or lead to local reactions, which were observed in 29% of involved patients.\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eThis multicenter, randomized, double-blind, placebo-controlled trial of anakinra in the treatment of giant cell arteritis was prematurely discontinued. However, the intent-to-treat analysis of the 30 included patients failed to demonstrate a beneficial effect of anakinra in reducing the risk of relapse or GC exposure. The present study does not support the use of anakinra for 4 months at the time of diagnosis in GCA patients.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eAEs: adverse events\u003c/p\u003e\n\u003cp\u003eANK: anakinra\u003c/p\u003e\n\u003cp\u003eCT: computed tomography\u003c/p\u003e\n\u003cp\u003eGCs: glucocorticoids\u003c/p\u003e\n\u003cp\u003eGCA: giant cell arteritis\u003c/p\u003e\n\u003cp\u003eHAQ: health assessment\u0026nbsp;questionnaire\u003c/p\u003e\n\u003cp\u003eIL: interleukin\u003c/p\u003e\n\u003cp\u003eMRA: magnetic resonance angiography\u003c/p\u003e\n\u003cp\u003eMTX: methotrexate\u003c/p\u003e\n\u003cp\u003ePBO: placebo\u003c/p\u003e\n\u003cp\u003ePET/CT:\u0026nbsp;positron\u0026nbsp;emission tomography coupled with computed tomography\u003c/p\u003e\n\u003cp\u003ePMR: polymyalgia rheumatica\u003c/p\u003e\n\u003cp\u003eQoL: quality of life\u003c/p\u003e\n\u003cp\u003eSF36: short form\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from all participating patients.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data\u0026nbsp;are available\u0026nbsp;upon\u0026nbsp;reasonable request to the corresponding author.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHubert de Boysson reports receiving fees for serving on advisory boards from Roche-Chugai and Novartis and lecture fees from Roche-Chugai, Novartis, Fresenius Kabi, GlaxoSmithKline, Amicus therapeutics, and Sanofi.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by the French PHRC (Protocole Hospitalier de Recherche Clinique) program.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors\u0026apos;\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003econtributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHdB, KHL, LG, TQ, EL, HB, NLG, AlA, AD, SD, JB, GM, NMS, AS, BLM, GP, JJP and AcA acquired the data and were involved in the interpretation of the results and in the review of the manuscript. HdB, AS, JJP and AcA designed the study. HdB and AcA wrote the first draft of the manuscript, which was read, corrected and approved by all the authors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSalvarani C, Cantini F, Hunder GG. Polymyalgia rheumatica and giant-cell arteritis. Lancet. 2008;372:234-45.\u003c/li\u003e\n\u003cli\u003eShick RM, Baggenstoss AH, Fuller BF, Polley HF. Effects of cortisone and ACTH on periarteritis nodosa and cranial arteritis. Proc Staff Meet Mayo Clin. 1950;25:492-4.\u003c/li\u003e\n\u003cli\u003eHellmich B, Agueda A, Monti S, Buttgereit F, de Boysson H, Brouwer E, et al. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020;79:19-30.\u003c/li\u003e\n\u003cli\u003eMaz M, Chung SA, Abril A, Langford CA, Gorelik M, Guyatt G, et al. 2021 American college of rheumatology/vasculitis foundation guideline for the management of giant cell arteritis and takayasu arteritis. Arthritis Rheumatol. 2021;73:1349-65.\u003c/li\u003e\n\u003cli\u003eMainbourg S, Addario A, Samson M, Puechal X, Francois M, Durupt S, et al. Prevalence of giant cell arteritis relapse in patients treated with glucocorticoids: a meta-analysis. Arthritis Care Res (Hoboken). 2020;72:838-49.\u003c/li\u003e\n\u003cli\u003eProven A, Gabriel SE, Orces C, O\u0026apos;Fallon WM, Hunder GG. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003;49:703-8.\u003c/li\u003e\n\u003cli\u003eBroder MS, Sarsour K, Chang E, Collinson N, Tuckwell K, Napalkov P, et al. Corticosteroid-related adverse events in patients with giant cell arteritis: a claims-based analysis. Semin Arthritis Rheum. 2016;46:246-52.\u003c/li\u003e\n\u003cli\u003eCastan P, Dumont A, Deshayes S, Boutemy J, Martin Silva N, Maigne G, et al. Impact of glucocorticoid cumulative doses in a real-life cohort of patients affected by giant cell arteritis. J Clin Med. 2022;11:1034.\u003c/li\u003e\n\u003cli\u003eSamson M, Corbera-Bellalta M, Audia S, Planas-Rigol E, Martin L, Cid MC, et al. Recent advances in our understanding of giant cell arteritis pathogenesis. Autoimmun Rev. 2017;16:833-44.\u003c/li\u003e\n\u003cli\u003eMahr AD, Jover JA, Spiera RF, Hernandez-Garcia C, Fernandez-Gutierrez B, Lavalley MP, et al. Adjunctive methotrexate for treatment of giant cell arteritis: an individual patient data meta-analysis. Arthritis Rheum. 2007;56:2789-97.\u003c/li\u003e\n\u003cli\u003eStone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, et al. Trial of tocilizumab in giant-cell arteritis. N Engl J Med. 2017;377:317-28.\u003c/li\u003e\n\u003cli\u003ePountain G, Hazleman B, Cawston TE. Circulating levels of IL-1beta, IL-6 and soluble IL-2 receptor in polymyalgia rheumatica and giant cell arteritis and rheumatoid arthritis. Br J Rheumatol. 1998;37:797-8.\u003c/li\u003e\n\u003cli\u003eSchett G, Dayer JM, Manger B. Interleukin-1 function and role in rheumatic disease. Nat Rev Rheumatol. 2016;12:14-24.\u003c/li\u003e\n\u003cli\u003eLy KH, Stirnemann J, Liozon E, Michel M, Fain O, Fauchais AL. Interleukin-1 blockade in refractory giant cell arteritis. Joint Bone Spine. 2014;81:76-8.\u003c/li\u003e\n\u003cli\u003eDeshayes S, Ly KH, Rieu V, Maigne G, Martin Silva N, Manrique A, et al. Steroid-sparing effect of anakinra in giant-cell arteritis: a case series with clinical, biological and iconographic long-term assessments. Rheumatology (Oxford). 2021;61:400-6.\u003c/li\u003e\n\u003cli\u003eLangford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, et al. A randomized, double-blind trial of abatacept (CTLA-4Ig) for the treatment of giant cell arteritis. Arthritis Rheumatol. 2017;69:837-45.\u003c/li\u003e\n\u003cli\u003eVenhoff N, Schmidt WA, Bergner R, Rech J, Unger L, Tony HP, et al. Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2023;5:e341-50.\u003c/li\u003e\n\u003cli\u003eConway R, O\u0026apos;Neill L, Gallagher P, McCarthy GM, Murphy CC, Veale DJ, et al. Ustekinumab for refractory giant cell arteritis: A prospective 52-week trial. Semin Arthritis Rheum. 2018;48:523-8.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"arthritis-research-and-therapy","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"arrt","sideBox":"Learn more about [Arthritis Research \u0026 Therapy](http://arthritis-research.biomedcentral.com/)","snPcode":"13075","submissionUrl":"https://submission.nature.com/new-submission/13075/3","title":"Arthritis Research \u0026 Therapy","twitterHandle":"@ArthritisRes","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"giant cell arteritis, anakinra, glucocorticoids, interleukin-1, quality of life","lastPublishedDoi":"10.21203/rs.3.rs-5231536/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5231536/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eEfficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis phase 3 study (NCT02902731) was a prospective multicenter, randomized, double-blind, placebo-controlled trial conducted over a 52-week period. GCA patients were randomized 1:1. From inclusion to week 16 (W16), patients in the anakinra (ANK) group received a daily subcutaneous injection of 100 mg of anakinra, whereas patients in the other group received placebo (PBO). In both arms, glucocorticoid (GC) discontinuation was planned at week 52 (W52). The endpoints were the relapse rates at W16, W26, and W52 and the completion of GC tapering. Given the emergence of the SARS-CoV-2 pandemic, the study was stopped prematurely.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThirty patients with new GCA diagnoses from 5 centers were randomized as follows: 17 in the ANK group and 13 in the PBO group. During the first 16 weeks, the relapse rates were 12% (n\u0026thinsp;=\u0026thinsp;2) and 23% (n\u0026thinsp;=\u0026thinsp;3) in the ANK and PBO groups, respectively (p\u0026thinsp;=\u0026thinsp;0.63). At week 26, 12 (40%) patients had relapsed: 8 (47%) in the ANK group and 4 (31%) in the PBO group (p\u0026thinsp;=\u0026thinsp;0.47). At W52, the relapse rate (overall, 50%) did not differ between the ANK group (53%; 9/17 patients) and the PBO group (46%; 6/13 patients) (p\u0026thinsp;=\u0026thinsp;1). Two patients in each group discontinued GCs (p\u0026thinsp;=\u0026thinsp;0.87). Seven serious AEs were reported in five patients, including 4 in patients receiving ANK.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eAlthough prematurely discontinued, this study does not support the use of 4 months of treatment with anakinra combined with GCs to reduce the risk of relapse or GC exposure.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eClinicalTrials.gov NCT02902731\u003c/p\u003e","manuscriptTitle":"Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-10-23 06:28:08","doi":"10.21203/rs.3.rs-5231536/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-12-10T17:02:47+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-12-10T13:46:11+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-11-23T18:45:05+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-11-17T16:32:51+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"145381652393747253602800146310339580043","date":"2024-11-08T11:35:23+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"145510187317708549202704111919199446284","date":"2024-11-06T11:51:53+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"94624239650090513491134383954803404876","date":"2024-11-05T12:42:59+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-11-05T12:04:42+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-10-11T06:58:47+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-10-11T05:56:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"Arthritis Research \u0026 Therapy","date":"2024-10-09T09:55:04+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"arthritis-research-and-therapy","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"arrt","sideBox":"Learn more about [Arthritis Research \u0026 Therapy](http://arthritis-research.biomedcentral.com/)","snPcode":"13075","submissionUrl":"https://submission.nature.com/new-submission/13075/3","title":"Arthritis Research \u0026 Therapy","twitterHandle":"@ArthritisRes","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3b635ebb-3ed3-4e88-ad9f-a7e14a9b1974","owner":[],"postedDate":"October 23rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-06-09T16:00:43+00:00","versionOfRecord":{"articleIdentity":"rs-5231536","link":"https://doi.org/10.1186/s13075-025-03493-z","journal":{"identity":"arthritis-research-and-therapy","isVorOnly":false,"title":"Arthritis Research \u0026 Therapy"},"publishedOn":"2025-06-07 15:57:16","publishedOnDateReadable":"June 7th, 2025"},"versionCreatedAt":"2024-10-23 06:28:08","video":"","vorDoi":"10.1186/s13075-025-03493-z","vorDoiUrl":"https://doi.org/10.1186/s13075-025-03493-z","workflowStages":[]},"version":"v1","identity":"rs-5231536","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5231536","identity":"rs-5231536","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}