Efficacy and Safety of Low- to Medium-Dose Telitacicept in Adults with High-Risk Progressive IgA Nephropathy: A Retrospective Real-World Study

Efficacy and Safety of Low- to Medium-Dose Telitacicept in Adults with High-Risk Progressive IgA Nephropathy: A Retrospective Real-World Study | 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 Efficacy and Safety of Low- to Medium-Dose Telitacicept in Adults with High-Risk Progressive IgA Nephropathy: A Retrospective Real-World Study Juan Pei, Xiuhua Xu, Ruihong Huang, Xuejuan Sun, Jun Zhang, Xing Chen, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7621514/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 17 Dec, 2025 Read the published version in BMC Nephrology → Version 1 posted 10 You are reading this latest preprint version Abstract Objective: The purpose of this study was to evaluate the efficacy and safety of low- to medium-dose (160 mg/W or 80 mg/W) telitacicept in adults at high risk of progression to IgA nephropathy. Methods: This was a single-center retrospective study. The study included adults at high risk for progression of IgA nephropathy who were treated with telitacicept between November 2022 and April 2024 and followed for at least 24 weeks. Results: In this study of 11 patients, telitacicept significantly reduced proteinuria by 64.38% (p < 0.001) and increased eGFR by 23.18% (p = 0.005) at week 24. Both the 80 mg and 160 mg dose groups demonstrated significant reductions in proteinuria (68.67% and 59.23%, respectively, both p < 0.001) and urinary RBC counts. The overall response rate was 90.91%. Telitacicept demonstrated a favorable safety profile, with only mild injection-site reactions reported (18.2%) and no serious adverse events. Conclusion: In this real-world study, low- to medium-dose of telitacicept combined with conventional therapy showed rapid onset efficacy and safety for treating high-risk progressive IgA patients. Telitacicept IgA nephropathy 24-hour urinary protein glomerular filtration rate urinary red blood cell count Figures Figure 1 Figure 2 Figure 3 INTRODUCTION IgA nephropathy (IgAN), the most common primary glomerular disease in China, accounts for 24.09–35.80% of biopsy-diagnosed renal diseases and progresses to end-stage renal disease (ESRD) in 20–40% of patients within 10–20 years of initial clinical presentation( 1 , 2 ). The disease exhibits heterogeneous clinical and pathological manifestations, with a complex pathogenesis rooted in the "four-hit" hypothesis, yet lacks specific therapeutic approaches( 3 ). B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) play critical roles in IgAN pathogenesis( 4 – 6 ). Telitacicept, a dual BLyS/APRIL inhibitor, demonstrated promising efficacy and safety in Phase II trials for IgAN( 7 , 8 ), with ongoing Phase III trials focusing on 160 mg and 240 mg doses. However, in the real world, the clinical value of telitacicept is still unclear. This study evaluates the efficacy and safety of low- to medium-dose of telitacicept (80–160 mg/week) in adults with high-risk progressive IgAN in real world. Patients and methods Study population This single-center retrospective study included 11 adults with high-risk IgAN treated with telitacicept (160 mg/week or 80 mg/week) between November 2022 and April 2024, with ≥ 24 weeks of follow-up. Patients included met the following criteria ( 10 ): ( 1 ) Biopsy-confirmed IgAN with high progression risk, defined as persistent proteinuria (> 0.5 g/day or urine protein-to-creatinine ratio > 0.5 mg/mg) despite ≥ 6 months of renin-angiotensin system inhibitors (RASI), steroids, or immunosuppressants, or significant steroid-related adverse effects( 9 , 10 ); ( 2 )Age ≥ 18 years; ( 3 ) eGFR ≥ 35 mL/min/1.73m² (calculated using CKD-EPI formula) ; ( 4 ) Intolerance to or suboptimal response to steroids/immunosuppressants, or patient preference for telitacicept. Patients were excluded from the study for the following reasons: Secondary IgAN, active infections, or malignancies. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of The First Affiliated Hospital of Xiamen University ((IRB approval No. 186 [2025]​ ), informed consent was obtained from all patients before receiving telitacicept treatment. Clinical trial number: not applicable. Data collection This study was a single-center retrospective study. General patient information (gender, age, BMI, blood pressure) and renal pathology were collected. The last assessment results before treatment with different doses of Telitacicept (160 mg/W or 80 mg/W) were used and compared with the indicators at 12 weeks and 24 weeks of medication. The main observation indicators were urine protein quantification, plasma albumin (ALB), serum creatinine (CRE), eGFR, and urine red blood cell count. Secondary observation indicators were blood pressure, blood urea (BUN), hemoglobin (HB), white blood cell count, lymphocyte count, blood uric acid (UA), blood glucose (GLU), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (CHO), and triglycerides (TG). Efficacy evaluation ( 1 ) Complete remission (CR), urine protein quantification ≤ 0.3g/24h, and stable renal function (eGFR decrease ≤ 30%); ( 2 ) Partial remission (PR), urine protein quantification reduction ≥ 50%, and stable renal function, but not reaching complete remission; ( 3 ) Ineffective, not meeting the criteria of complete remission and partial remission. Outcomes The Primary Outcomes included: Changes in 24-hour urinary protein, eGFR. Secondary outcomes included: Hematuria, adverse events, the rates of complete remission (CR), partial remission (PR) and no remission. Safety assessment The occurrence of adverse events (AEs) and serious adverse events (SAEs) were carefully assessed. SAEs were classified according to predefined criteria: events posing life-threatening risks, resulting in mortality, necessitating unplanned hospitalization or prolongation of existing hospitalization, or inducing persistent/permanent organ dysfunction. The evaluation included injection site reactions, systemic or localized infections, cardio-cerebrovascular incidents, hepatotoxicity, gastrointestinal system damage, hematological system damage, reproductive system damage, osteonecrosis or pathological fractures and other clinically significant AEs. Statistical analysis Data were analyzed using SPSS 19.0. For continuous variables, normally distributed data were presented as mean ± standard deviation (SD) and non-normally distributed data were presented as median [interquartile range (IQR) 25–75%]. Parametric tests such as a paired samples t test and non-parametric tests such as Wilcoxon rank sum tests were used to compare the differences at different time points (baseline, 12 weeks, and 24 weeks). All tests were two-sided, and a p-value of < 0.05 was considered statistically significant. RESULTS Study population and baseline characteristics The cohort comprised 11 patients (81.82% female; median age 35 years [interquartile range (IQR) 32–39]; median disease duration 13 months [IQR 7–23]). Baseline clinical parameters included mean 24-hour urinary protein excretion of 1.65 ± 0.78 g/24h, mean estimated glomerular filtration rate (eGFR) of 67.59 ± 29.23 mL/min/1.73 m², and mean serum albumin of 40.09 ± 4.67 g/L. While concomitant medications remained stable throughout the treatment, glucocorticoid dosages were gradually reduced. The baseline characteristics of all patients are shown in Table 1 . Table 1 Baseline characteristics of study participants Characteristics Telitacicept 80 mg (n = 6) Telitacicept 160 mg ( n = 5) All ( n = 11) Age, median (IQR), year 32 (28, 37) 38 (35,39) 35 (32, 39) Female sex, n (%) 5 (83.33) 4 (80) 9 (81.82) Weight, mean (SD), kg 56.17 ± 4.72 63.60 ± 4.64 59.55 ± 3.37 BMI, mean (SD), kg/m 2 22.68 ± 1.58 24.45 ± 1.56 23.48 ± 1.09 Blood pressure, mean (SD), mmHg Systolic 116.33 ± 2.39 126.20 ± 3.77 120.82 ± 2.56 Diastolic 74.16 ± 1.19 78.00 ± 1.64 75.91 ± 1.12 Past systemic corticosteroid therapy, n (%) 6 (100) 5 (100) 11 (100) Past other immunosuppressant therapy, n (%) 2 (33.33) 4 (80) 6 (54.55) Concomitant medications with telitacicept, n (%) ACEI/ARBs 6 (100) 5 (100) 11 (100) SGLT2 0 (0) 3 (60%) 3 (27.27) Prednisone only 1 (16.7) 1 (20) 2 (18.18) Prednisone + Mycophenolate mofetil 1 (16.7) 0 (0) 1 (9.09) Prednisone + Tacrolimus 0 (0) 1 (20) 1 (9.09) Oxford classification, n M 0/1 0/6 0/5 0/11 E 0/1 4/2 5/0 9/2 S 0/1 0/6 0/5 0/11 T 0/1/2 4/2/0 2/2/1 6/4/1 C 0/1/2 1/5/0 2/3/0 3/8/0 Treatment duration, median (IQR), months 23 (13,32) 7 ( 7 , 10 ) 13 (7,23) Hemoglobin, mean (SD), g/L 113.67 ± 20.31 137.60 ± 16.68 124.54 ± 21.77 ALB, mean (SD), g/L 39.58 ± 5.95 40.70 ± 3.10 40.09 ± 4.67 Total triglyceride, median (IQR), mmol/L 0.96 (0.75, 1.26) 2.62 (1.00, 3.03) 1.10 (0.84, 2.83) Total cholesterol, mean (SD), mmol/L 4.97 ± 0.45 6.46 ± 0.44 5.65 ± 0.38 Urea, mean (SD), mmol/L 7.82 ± 2.92 5.24 ± 2.86 6.64 ± 3.06 Creatinine, mean (SD), µmol/L 123.50 ± 53.63 94.00 ± 47.84 110.01 ± 50.90 Uric Acid, mean (SD), µmol/L 383.67 ± 109.04 355.00 ± 175.22 370.64 ± 135.83 eGFR, mean (SD), mL/min/1.73 m 2 54.82 ± 16.96 82.92 ± 35.19 67.59 ± 29.23 24-hour proteinuria, mean (SD), g/day 1.25 ± 0.78 2.14 ± 0.50 1.65 ± 0.78 Urinary RBC count (cells/µl), median (IQR) 424.55 (70.10, 1403.60) 87.20 (54.90, 372.95) 121.60 (62.00, 641.30) ACEI, angiotensin-converting enzyme inhibitor; ALB, albumin; ARBs, angiotensin receptor blockers; BMI, body mass index; CR, complete remission; eGFR, estimated glomerular filtration rate; IQR, interquartile range; PR, partial remission; RBC, red blood cell; SD, standard deviation; SGLT2, sodium-glucose cotransporter-2. Primary outcomes Effects on Proteinuria Significant proteinuria reduction was observed 12 weeks after initiating telitacicept, from 1.65 ± 0.78 g/24h to 0.93 ± 0.62 g/24h for 24-hour proteinuria, with mean reduction of 45.53% (95% CI: 31.97 – 59.09, p < 0.001). By week 24, the level of 24-hour proteinuria reduced to 0.60 ± 0.40 g/24h, representing a reduction of 64.38% (95% CI: 55.56 – 73.21, p < 0.001). Similar to the trend observed in the full cohort, the level of 24-hour proteinuria in telitacicept 80 mg group at week 12 decreased from 1.25 ± 0.78 g/24h to 0.52 ± 0.32 g/24h, with mean decrease of 54.70% (95% CI: 34.19 – 75.72, p = 0.001)), to 0.35 ± 0.18 g/24h at week 24, with mean decrease of 68.67% (95% CI: 53.83 – 85.51, p < 0.001). In telitacicept 160 mg group, the level of 24-hour proteinuria at week 12 decreased from 2.14 ± 0.50 g/24h to 1.43 ± 0.55 g/24h, with mean decrease of 34.53% (95% CI: 14.37 – 54.68, p = 0.009), to 0.90 ± 0.41 g/24h at week 24, with mean decrease of 59.24% (95% CI: 45.61 – 72.88, p < 0.001). (Figs. 1 a, b). Effects on Estimated Glomerular Filtration Rate The level of eGFR significantly improved from 67.59 ± 29.23 mL/min/1.73 m 2 to 74.77 ± 28.56 mL/min/1.73 m 2 at week 12, with mean absolute increase: 7.18 ± 6.54 mL/min/1.73m² and mean percentage increase of 12.60% (95% CI: 5.84 – 19.36, P = 0.002), and further increased to 78.59 ± 24.46 mL/min/1.73 m 2 at week 24, with mean absolute increase: 11.00 ± 12.16 mL/min/1.73m² and mean percentage increase of 23.18% (95% CI: 8.60 – 37.76, P = 0.005). Similar to the trend observed in the full cohort, eGFR at 12 weeks in telitacicept 80 mg group increased from 54.82 ± 16.96 mL/min/1.73 m 2 to 65.58 ± 22.78 mL/min/1.73 m 2 , with mean absolute increase: 10.76 ± 6.81 mL/min/1.73m² and mean percentage increase of 18.78% (95% CI: 9.78 – 27.78, p = 0.003)), and 71.54 ± 21.66 mL/min/1.73 m 2 , with mean absolute increase: 16.72 ± 8.67 mL/min/1.73m² and mean percentage increase of 32.72% (95% CI: 15.58 – 49.85, p = 0.004). In telitacicept 160 mg group, eGFR remained stable from 82.92 ± 35.19 mL/min/1.73 m 2 to 85.81 ± 33.33 mL/min/1.73 m 2 at week 12, with mean absolute increase: 2.89 ± 2.58 mL/min/1.73m² and mean percentage increase of 5.19% (95% CI: − 2.17 – 12.55, p = 0.122), and 87.06 ± 27.30 mL/min/1.73 m 2 at week 24, with mean absolute increase: 4.14 ± 12.95 mL/min/1.73m² and mean percentage increase of 11.73% (95% CI: − 17.23 – 40.68, p = 0.324). (Figs. 2 a, b). Secondary outcomes Effects on Hematuria In the whole telitacicept group, the urinary red blood cell (RBC) counts at 12 weeks decreased from 121.60 cells/µl (IQR 62.00–641.30) to 59.60 cells/µl (IQR 26.20–85.80) (P = 0.004), to 34.60 cells/µl (IQR 22.20–55.10) at week 24(P = 0.003). In telitacicept 80 mg group, from 424.55 cells/µl (IQR 70.10–1403.60) to 50.85 cells/µl (IQR 26.20–307.13) at week 12 (P = 0.028), to 33.30 cells/µl (IQR 13.53–160.63) at week 24 (P = 0.028). In telitacicept 160 mg group, from 87.20 cells/µl (IQR 54.90–372.95) to 66.10 cells/µl (IQR 26.15–179.55) at week 12 (P = 0.080), to 38.60 cells/µl (IQR 23.70–49.15) at week 24 (P = 0.043). (Figs. 3 ). Steroid-Sparing Effect Telitacicept demonstrated a notable steroid-sparing effect. In our study, among the 4 patients using glucocorticoids, the mean dose decreased from 18.75 mg/d at baseline to 5.0 mg/d at the end of follow-up, representing 73.33% reduction in steroid dosage. In addition, 2 patients achieved complete steroid discontinuation. Treatment efficacy At the last follow-up of each patient, the whole telitacicept group had 7 patients who had achieved PR, 3 patients who had achieved CR and an overall efficacy rate of 90.91%. In the 80 mg telitacicept subgroup there were 3 patients who had achieved PR, 3 patients who had achieved CR and an overall efficacy rate of 100%. Similarly, in the 160 mg telitacicept group, there were 4 patients who had achieved PR, 0 patients who had achieved CR and an overall efficacy rate of 80%. (Table 2 ) Table 2 Efficacy rates of participants during each follow-up period. Group Overall efficacy rate, n (%) CR, n (%) PR, n (%) Ineffective, n (%) All telitacicept (n = 11) 10 (90.91) 3 (27.27) 7 (63.64) 1 (9.09) Telitacicept 160 mg (n = 5) 4 (80) 0 (0) 4 (80) 1 (20) Telitacicept 80 mg (n = 6) 6 (100) 3 (50) 3 (50) 0 (0) CR, complete remission; PR, partial remission. Safety and AEs During the follow-up periods, no SAEs were observed. In the whole telitacicept group, only 2 patients in 160 mg telitacicept subgroup experienced local skin reactions (incidence of AEs was 18.18%). Discussion IgA nephropathy, classified as an autoimmune-related kidney disease, is characterized primarily by the deposition of galactose-deficient IgA within the glomerular mesangial area( 3 ). Conventional treatment strategies for IgA nephropathy are primarily based on supportive care, often combined with immunosuppressive therapy( 11 ). Studies have shown that the B-cell stimulatory factors B lymphocyte stimulator (BLyS/BAFF) and A Proliferation-Inducing Ligand (APRIL) can accelerate the progression of IgA nephropathy( 4 – 6 ). Telitacicept, a dual-target inhibitor blocking both APRIL and BLyS, also impacts the secretion of autoantibodies by plasma cells( 12 ). This mechanism provides a rationale for its use in treating IgA nephropathy. The phase II telitacicept trial (NCT04291781; registered on February 28, 2020) have affirmed telitacicept’s efficacy and safety in IgA treatment( 8 ), while further research must delineate its practical benefits in routine clinical applications. Pioneering the real-world assessment of low-to-medium dose telitacicept (80–160 mg/week), this study reveals its efficacy in high-risk progressive IgAN adults refractory to conventional therapy. We observed a triad of renoprotective effects: rapid proteinuria decline (64.4%, P < 0.001), unprecedented eGFR elevation (+ 23.2%, P = 0.005), and significant hematuria resolution (71.5% RBC reduction)—achieved with minimal toxicity. Notably, the 80 mg dose regimen achieved comparable efficacy to 160 mg in both proteinuria reduction (68.67% vs 59.23%) and eGFR improvement (+ 32.72% vs + 11.73%), mirroring dose-response patterns observed in lupus nephritis trials( 13 ). This finding on lower-dose efficacy is of pivotal clinical importance when viewed in the context of accumulating real-world evidence. The compelling efficacy observed in our cohort is highly consistent with a recent study by Liu et al. in 16 pediatric patients (including 11 with IgAN), which reported a 79.12% reduction in 24-hour proteinuria at week 48 and a 62.5% complete remission rate( 14 ). This convergence of findings across independent centers and age groups strengthens the validity of our results despite the sample size constraint. Furthermore, while another large real-world study in adults by Weng et al. corroborated the proteinuria-reducing effect of telitacicept, it utilized the conventional 240 mg dose ( 15 ). The comparable efficacy of our 80 mg regimen, therefore, presents a distinct and pragmatic advantage for chronic disease management. The potential for maintaining clinical efficacy while simultaneously minimizing drug exposure, reducing treatment costs, and potentially improving long-term safety positions this lower-dose strategy as a highly attractive and patient-centric therapeutic option. This study establishes that telitacicept provides rapid onset renoprotection in high-risk IgAN patients, with clinically significant proteinuria reduction and eGFR improvement emerging as early as Week 12. This early response offers a valuable therapeutic window for patients refractory to conventional therapies, enabling timely intervention before irreversible fibrosis develops. By Week 24, these benefits intensified—demonstrating not only sustained efficacy but also progressive renal function recovery—thereby supporting telitacicept's transition from short-term induction to long-term management in real-world practice. Another clinically significant observation was telitacicept's pronounced effect on hematuria, with urinary red blood cells decreasing by 71.54% at Week 24. This finding addresses an important therapeutic gap, as persistent hematuria independently predicts renal function decline in IgA nephropathy according to contemporary studies( 16 – 18 ), yet remains unaddressed in current management guidelines. Wang et al.( 19 ) reported median RBC decrease from 35.40 to 13.60 cells/µL (61.58% decline) consistent directionally with our study, supporting mechanistic coherence. Confirmatory trials are warranted to establish hematuria as a validated response marker. Furthermore, telitacicept exhibited significant steroid-sparing effects: glucocorticoid doses decreased by 73.33% overall, with 18.18% of patients achieving complete discontinuation. Crucially, even in the 4 patients receiving concomitant immunosuppressants, no additive immunosuppressive risks were observed, underscoring its favorable safety profile during combination therapy. These findings provide critical evidence for optimizing IgAN treatment paradigms through targeted biologics. While our therapeutic outcomes align with the established efficacy trajectory of the phase II telitacicept trial (NCT04291781), enhanced renoprotection was observed—characterized by superior proteinuria reduction (64.38% vs 38–49%) and significant eGFR improvement (+ 23.18% vs stabilization)—likely attributable to two pivotal factors: 1) the high prevalence of treatment-responsive pathology (72.73% exhibiting crescents with regenerative potential), and 2) concomitant immunosuppression in refractory cases (36.37% receiving glucocorticoids ± immunosuppressants, potentially amplifying efficacy though drug interactions require further elucidation). The favorable safety profile observed in our cohort—characterized by only mild injection-site reactions (18.18%) and absence of serious infections—is consistent with the established mechanism of Telitacicept, which has fewer side effects than conventional medications as it is metabolized intracellularly without hepatic/renal clearance( 12 ). Study limitations include the small sample size, absence of a parallel control group, and relevant short observational time, which was only 24 weeks. Future investigations should validate these findings in large-scale and long-term trial. In conclusion, low-to-medium dose telitacicept achieves rapid multisystem benefits in high-risk IgA nephropathy, contributing to reductions in proteinuria, increases in the eGFR, significantly reduces hematuria, and maintaining a favorable safety profile. The 80 mg regimen's non-inferior efficacy underscores its viability for chronic management, addressing critical unmet needs. Declarations CONFLICT OF INTEREST STATEMENT The author declares no conflicts of interest. FUNDING None Author Contribution Y.L. and L.S. designed the study. J.P., X.X. collected the clinical data of patients. J.P. and X.X. performed statistical analyses. J.P. and X.X. drafted the manuscript. Y.L., L.S., X.S., X.C., J.Z., R.H., L.Y. and H.Z. checked and revised the article. All authors read and approved the final manuscript. ACKNOWLEDGEMENTS We are grateful to all participants, the doctors, and nurses of the Nephrology department for their efforts and contributions to this research. Data Availability The data underlying this article will be shared on reasonable request to the corresponding author. References Hu R, Quan S, Wang Y, Zhou Y, Zhang Y, Liu L, et al. Spectrum of biopsy proven renal diseases in Central China: a 10-year retrospective study based on 34,630 cases. Sci Rep. 2020 Jul 3;10(1):10994. Floege J, Barratt J. IgA nephropathy: a perspective for 2021. 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Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria. Kidney Int Rep. 2023 Mar 1;8(3):499–506. Le W, Liang S, Hu Y, Deng K, Bao H, Zeng C, et al. Long-term renal survival and related risk factors in patients with IgA nephropathy: results from a cohort of 1155 cases in a Chinese adult population. Nephrology Dialysis Transplantation. 2012 Apr 1;27(4):1479–85. Tang C, Chen P, Si FL, Lv JC, Shi SF, Zhou XJ, et al. Time-Varying Proteinuria and Progression of IgA Nephropathy: A Cohort Study. American Journal of Kidney Diseases. 2024 Aug;84(2):170-178.e1. Floege J, Rauen T, Tang SCW. Current treatment of IgA nephropathy. Semin Immunopathol. 2021 Oct 8;43(5):717–28. Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep 31;81(14):1671–5. Gao S, Yang C, Huang B, Yang L, Lu L, Yang H, et al. Comparative efficacy and safety of different recommended doses of telitacicept in patients with systemic lupus erythematosus in China: a systematic review and meta-analysis. Vol. 15, Frontiers in Immunology. Frontiers Media SA; 2024. Liu J, Han X, Jiang X, Gao X, Li G, Fang X, et al. Efficacy and Safety of Telitacicept as an Add-On Therapy for Refractory Immunoglobulin A Nephropathy or Immunoglobulin A Vasculitis Nephropathy in Children. Kidney Int Rep. 2025 Mar 1;10(3):940–3. Weng Q, Ouyang Y, Chen Z, Jin Y, Xu J, Liu J, et al. Efficacy and safety of telitacicept in IgA nephropathy: Real-world study outcomes. Clin Kidney J. 2025 Jun 1;18(6). Huang Z, Zhang J, Chen B, Li D, You X, Zhou Y, et al. Clinical Significance of Persistent Hematuria Degrees in Primary IgA Nephropathy: A Propensity Score-Matched Analysis of a 10-Year Follow-Up Cohort. Am J Nephrol. 2023 May 1;54(1–2):62–73. Yu G zhen, Guo L, Dong J feng, Shi S fang, Liu L jun, Wang J wei, et al. Persistent Hematuria and Kidney Disease Progression in IgA Nephropathy: A Cohort Study. American Journal of Kidney Diseases. 2020 Jul 1;76(1):90–9. He P, Wang H, Huang C, He L. Hematuria was a high risk for renal progression and ESRD in immunoglobulin a nephropathy: a systematic review and meta-analysis. Ren Fail. 2021;43(1):488–99. Wang M, Ma J, Yao L, Fan Y. Efficacy and safety of telitacicept, a BLyS/APRIL dual inhibitor, in the treatment of IgA nephropathy: A retrospective case-control study. Clin Kidney J. 2024 Oct 1;17(10). Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 17 Dec, 2025 Read the published version in BMC Nephrology → Version 1 posted Editorial decision: Revision requested 22 Oct, 2025 Reviews received at journal 12 Oct, 2025 Reviews received at journal 12 Oct, 2025 Reviewers agreed at journal 05 Oct, 2025 Reviewers agreed at journal 05 Oct, 2025 Reviewers invited by journal 03 Oct, 2025 Editor invited by journal 03 Oct, 2025 Editor assigned by journal 30 Sep, 2025 Submission checks completed at journal 30 Sep, 2025 First submitted to journal 15 Sep, 2025 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-7621514","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":529660637,"identity":"0e126d70-098d-44ee-a019-6d6662316e9d","order_by":0,"name":"Juan Pei","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Juan","middleName":"","lastName":"Pei","suffix":""},{"id":529660638,"identity":"063a22f4-2e92-4cc2-aefa-00370aa2ac3a","order_by":1,"name":"Xiuhua Xu","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Xiuhua","middleName":"","lastName":"Xu","suffix":""},{"id":529660639,"identity":"9cadc495-1097-4dde-a6d6-c0e3bc691f21","order_by":2,"name":"Ruihong Huang","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Ruihong","middleName":"","lastName":"Huang","suffix":""},{"id":529660640,"identity":"e5c2e285-690e-4b0c-83e1-83bc49a4f4b5","order_by":3,"name":"Xuejuan Sun","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Xuejuan","middleName":"","lastName":"Sun","suffix":""},{"id":529660641,"identity":"1b3501fb-30a3-4642-a95d-d19623d0f8b9","order_by":4,"name":"Jun Zhang","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Jun","middleName":"","lastName":"Zhang","suffix":""},{"id":529660642,"identity":"efdc0d89-e830-4536-9dd3-609eeb829802","order_by":5,"name":"Xing Chen","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Xing","middleName":"","lastName":"Chen","suffix":""},{"id":529660643,"identity":"4d815583-f8a9-4db1-88b8-bc1f26cadbcf","order_by":6,"name":"Lijing Yao","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Lijing","middleName":"","lastName":"Yao","suffix":""},{"id":529660644,"identity":"925edd00-23b9-49a2-88ac-36c0140122e7","order_by":7,"name":"Hengyuan Zhang","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Hengyuan","middleName":"","lastName":"Zhang","suffix":""},{"id":529660645,"identity":"b452081e-b45d-4d62-bcd5-11d0f7deaba1","order_by":8,"name":"Leping Shao","email":"","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":false,"prefix":"","firstName":"Leping","middleName":"","lastName":"Shao","suffix":""},{"id":529660646,"identity":"152841a9-4988-44a1-8e08-ccedcca66000","order_by":9,"name":"Yinan Li","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAwUlEQVRIiWNgGAWjYBACPmYGhgNgFntj44MPxGhhg2vhOdxsOIMoLXCWRHqbNAdRWth5DA8X1NxJXDvzYYM0A4OdnG4DQYfxGByeceyZsdntxAbjAoZkY7MDxGjhYTssB9KSPIPhQOI24rT8O8xjdvNgw2EeorXwtgFtucHY2EykFraCw7x9h43NziQ2M84wIMIv/PyHN3/m+XY4cdvx489/fKiwkyOohYGBwwCJY4BTGTJgf0CUslEwCkbBKBjBAABNyUGNcOeZqAAAAABJRU5ErkJggg==","orcid":"","institution":"The First Affiliated Hospital of Xiamen University, Xiamen University","correspondingAuthor":true,"prefix":"","firstName":"Yinan","middleName":"","lastName":"Li","suffix":""}],"badges":[],"createdAt":"2025-09-15 14:09:32","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7621514/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7621514/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12882-025-04708-w","type":"published","date":"2025-12-17T15:57:23+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":93805923,"identity":"446b70cc-6220-4c25-8848-c7433287a1d2","added_by":"auto","created_at":"2025-10-17 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18:21:33","extension":"png","order_by":10,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":9747,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/aad51e9a96e13f0e91772629.png"},{"id":93804448,"identity":"4c17db84-bac9-4f73-b917-7a8e38b4251a","added_by":"auto","created_at":"2025-10-17 17:49:33","extension":"png","order_by":11,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":11816,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/26b91da72266151a5fb33126.png"},{"id":93806468,"identity":"358e19da-2157-48ac-8030-772561a6fd7b","added_by":"auto","created_at":"2025-10-17 18:13:33","extension":"png","order_by":12,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":9253,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage5.png","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/cf6f8a173a231735b2f3368a.png"},{"id":93804451,"identity":"0636f2c5-7fd6-4fc7-a7c2-2d94d43aaff1","added_by":"auto","created_at":"2025-10-17 17:49:33","extension":"xml","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":74398,"visible":true,"origin":"","legend":"","description":"","filename":"527e3da3afd7450eb4d0ce7daa0d8be81structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/9b9064e356fa722aa06a8cae.xml"},{"id":93805280,"identity":"1745ea5d-61f0-4814-9cb2-d9977a3e295d","added_by":"auto","created_at":"2025-10-17 17:57:33","extension":"html","order_by":14,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":80478,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/dfac937efbdfca26facf61f7.html"},{"id":93804434,"identity":"404e1c71-f8a6-4af2-8dce-572e981663c3","added_by":"auto","created_at":"2025-10-17 17:49:32","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":48206,"visible":true,"origin":"","legend":"\u003cp\u003eMean changes in proteinuria at baseline, 12 weeks and 24weeks. Data are expressed as mean values (bars indicate the standard error of the mean). (a) Absolute mean changes in 24-hour proteinuria from baseline in patients receiving telitacicept (80 mg/week or 160 mg/week). (b) Mean change (%) in 24-hour proteinuria from baseline in patients receiving telitacicept (80 mg/week or 160 mg/week).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/9230b4e11197eaf92fd8cc41.png"},{"id":93805273,"identity":"9d8a7586-03cd-4ceb-8f7f-a548ceebb450","added_by":"auto","created_at":"2025-10-17 17:57:32","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":46578,"visible":true,"origin":"","legend":"\u003cp\u003eMean changes in eGFR at baseline, 12 weeks and 24weeks. Data are expressed as mean values (bars indicate the standard error of the mean). (a) Absolute mean changes in eGFR from baseline in patients receiving telitacicept (80 or 160 mg/week) at each visit. (b) Mean change (%) in eGFR from baseline in patients receiving telitacicept (80 or 160 mg/week) at each visit. eGFR indicates the estimated glomerular filtration rate calculated using CKD-EPI. CKD-EPI, chronic kidney disease epidemiology collaboration; eGFR, estimated glomerular filtration rate.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/4bd6aa70d4f54664abefa5ca.png"},{"id":93804435,"identity":"a466740d-6b1c-4259-9281-00ef1241ff6c","added_by":"auto","created_at":"2025-10-17 17:49:32","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":16752,"visible":true,"origin":"","legend":"\u003cp\u003eMedian and IQR of urinary RBC counts (cells/μl) at baseline, 12 weeks and 24 weeks\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/f8b28cddaa57fc34ac0965d3.png"},{"id":98815642,"identity":"eb5a650c-2671-4cd6-8001-4ff4a70de4f2","added_by":"auto","created_at":"2025-12-22 16:15:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":901427,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7621514/v1/451ec822-c5e8-496b-bed5-3123c493d0d3.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy and Safety of Low- to Medium-Dose Telitacicept in Adults with High-Risk Progressive IgA Nephropathy: A Retrospective Real-World Study","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eIgA nephropathy (IgAN), the most common primary glomerular disease in China, accounts for 24.09\u0026ndash;35.80% of biopsy-diagnosed renal diseases and progresses to end-stage renal disease (ESRD) in 20\u0026ndash;40% of patients within 10\u0026ndash;20 years of initial clinical presentation(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). The disease exhibits heterogeneous clinical and pathological manifestations, with a complex pathogenesis rooted in the \"four-hit\" hypothesis, yet lacks specific therapeutic approaches(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eB-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) play critical roles in IgAN pathogenesis(\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Telitacicept, a dual BLyS/APRIL inhibitor, demonstrated promising efficacy and safety in Phase II trials for IgAN(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), with ongoing Phase III trials focusing on 160 mg and 240 mg doses. However, in the real world, the clinical value of telitacicept is still unclear. This study evaluates the efficacy and safety of low- to medium-dose of telitacicept (80\u0026ndash;160 mg/week) in adults with high-risk progressive IgAN in real world.\u003c/p\u003e"},{"header":"Patients and methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy population\u003c/h2\u003e\u003cp\u003eThis single-center retrospective study included 11 adults with high-risk IgAN treated with telitacicept (160 mg/week or 80 mg/week) between November 2022 and April 2024, with \u0026ge;\u0026thinsp;24 weeks of follow-up. Patients included met the following criteria (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e): (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) Biopsy-confirmed IgAN with high progression risk, defined as persistent proteinuria (\u0026gt;\u0026thinsp;0.5 g/day or urine protein-to-creatinine ratio\u0026thinsp;\u0026gt;\u0026thinsp;0.5 mg/mg) despite \u0026ge;\u0026thinsp;6 months of renin-angiotensin system inhibitors (RASI), steroids, or immunosuppressants, or significant steroid-related adverse effects(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e); (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)Age\u0026thinsp;\u0026ge;\u0026thinsp;18 years; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) eGFR\u0026thinsp;\u0026ge;\u0026thinsp;35 mL/min/1.73m\u0026sup2; (calculated using CKD-EPI formula) ; (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) Intolerance to or suboptimal response to steroids/immunosuppressants, or patient preference for telitacicept. Patients were excluded from the study for the following reasons: Secondary IgAN, active infections, or malignancies. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of The First Affiliated Hospital of Xiamen University ((IRB approval No. 186 [2025]​ ), informed consent was obtained from all patients before receiving telitacicept treatment. Clinical trial number: not applicable.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eData collection\u003c/h3\u003e\n\u003cp\u003eThis study was a single-center retrospective study. General patient information (gender, age, BMI, blood pressure) and renal pathology were collected. The last assessment results before treatment with different doses of Telitacicept (160 mg/W or 80 mg/W) were used and compared with the indicators at 12 weeks and 24 weeks of medication. The main observation indicators were urine protein quantification, plasma albumin (ALB), serum creatinine (CRE), eGFR, and urine red blood cell count. Secondary observation indicators were blood pressure, blood urea (BUN), hemoglobin (HB), white blood cell count, lymphocyte count, blood uric acid (UA), blood glucose (GLU), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (CHO), and triglycerides (TG).\u003c/p\u003e\n\u003ch3\u003eEfficacy evaluation\u003c/h3\u003e\n\u003cp\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) Complete remission (CR), urine protein quantification\u0026thinsp;\u0026le;\u0026thinsp;0.3g/24h, and stable renal function (eGFR decrease\u0026thinsp;\u0026le;\u0026thinsp;30%); (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Partial remission (PR), urine protein quantification reduction\u0026thinsp;\u0026ge;\u0026thinsp;50%, and stable renal function, but not reaching complete remission; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) Ineffective, not meeting the criteria of complete remission and partial remission.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eThe Primary Outcomes included: Changes in 24-hour urinary protein, eGFR. Secondary outcomes included: Hematuria, adverse events, the rates of complete remission (CR), partial remission (PR) and no remission.\u003c/p\u003e\n\u003ch3\u003eSafety assessment\u003c/h3\u003e\n\u003cp\u003eThe occurrence of adverse events (AEs) and serious adverse events (SAEs) were carefully assessed. SAEs were classified according to predefined criteria: events posing life-threatening risks, resulting in mortality, necessitating unplanned hospitalization or prolongation of existing hospitalization, or inducing persistent/permanent organ dysfunction. The evaluation included injection site reactions, systemic or localized infections, cardio-cerebrovascular incidents, hepatotoxicity, gastrointestinal system damage, hematological system damage, reproductive system damage, osteonecrosis or pathological fractures and other clinically significant AEs.\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis\u003c/h2\u003e\u003cp\u003eData were analyzed using SPSS 19.0. For continuous variables, normally distributed data were presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD) and non-normally distributed data were presented as median [interquartile range (IQR) 25\u0026ndash;75%]. Parametric tests such as a paired samples t test and non-parametric tests such as Wilcoxon rank sum tests were used to compare the differences at different time points (baseline, 12 weeks, and 24 weeks). All tests were two-sided, and a p-value of \u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e\u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003eStudy population and baseline characteristics\u003c/h2\u003e\u003cp\u003eThe cohort comprised 11 patients (81.82% female; median age 35 years [interquartile range (IQR) 32\u0026ndash;39]; median disease duration 13 months [IQR 7\u0026ndash;23]). Baseline clinical parameters included mean 24-hour urinary protein excretion of 1.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78 g/24h, mean estimated glomerular filtration rate (eGFR) of 67.59\u0026thinsp;\u0026plusmn;\u0026thinsp;29.23 mL/min/1.73 m\u0026sup2;, and mean serum albumin of 40.09\u0026thinsp;\u0026plusmn;\u0026thinsp;4.67 g/L. While concomitant medications remained stable throughout the treatment, glucocorticoid dosages were gradually reduced. The baseline characteristics of all patients are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eBaseline characteristics of study participants\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristics\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTelitacicept 80 mg (n\u0026nbsp;= 6)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eTelitacicept 160 mg (\u003cem\u003en\u003c/em\u003e\u0026nbsp;= 5)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eAll (\u003cem\u003en\u003c/em\u003e\u0026nbsp;= 11)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge, median (IQR), year\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e32 (28, 37)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e38 (35,39)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e35 (32, 39)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFemale sex, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (83.33)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (80)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e9 (81.82)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWeight, mean (SD), kg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e56.17\u0026thinsp;\u0026plusmn;\u0026thinsp;4.72\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e63.60\u0026thinsp;\u0026plusmn;\u0026thinsp;4.64\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e59.55\u0026thinsp;\u0026plusmn;\u0026thinsp;3.37\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBMI, mean (SD), kg/m\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e22.68\u0026thinsp;\u0026plusmn;\u0026thinsp;1.58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e24.45\u0026thinsp;\u0026plusmn;\u0026thinsp;1.56\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e23.48\u0026thinsp;\u0026plusmn;\u0026thinsp;1.09\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBlood pressure, mean (SD), mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSystolic\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e116.33\u0026thinsp;\u0026plusmn;\u0026thinsp;2.39\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e126.20\u0026thinsp;\u0026plusmn;\u0026thinsp;3.77\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e120.82\u0026thinsp;\u0026plusmn;\u0026thinsp;2.56\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDiastolic\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e74.16\u0026thinsp;\u0026plusmn;\u0026thinsp;1.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e78.00\u0026thinsp;\u0026plusmn;\u0026thinsp;1.64\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e75.91\u0026thinsp;\u0026plusmn;\u0026thinsp;1.12\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePast systemic corticosteroid therapy, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11 (100)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePast other immunosuppressant therapy, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (33.33)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (80)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6 (54.55)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eConcomitant medications with telitacicept,\u0026nbsp;\u003cem\u003en\u003c/em\u003e\u0026nbsp;(%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eACEI/ARBs\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11 (100)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSGLT2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (60%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3 (27.27)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrednisone only\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (16.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1 (20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2 (18.18)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrednisone\u0026thinsp;+\u0026thinsp;Mycophenolate mofetil\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (16.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1 (9.09)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrednisone\u0026thinsp;+\u0026thinsp;Tacrolimus\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1 (20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1 (9.09)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOxford classification,\u0026nbsp;\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eM 0/1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0/6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0/5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0/11\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eE 0/1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4/2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5/0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e9/2\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eS 0/1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0/6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0/5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0/11\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eT 0/1/2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4/2/0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2/2/1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6/4/1\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eC 0/1/2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1/5/0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2/3/0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3/8/0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTreatment duration, median (IQR), months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e23 (13,32)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e7 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e13 (7,23)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHemoglobin, mean (SD), g/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e113.67\u0026thinsp;\u0026plusmn;\u0026thinsp;20.31\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e137.60\u0026thinsp;\u0026plusmn;\u0026thinsp;16.68\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e124.54\u0026thinsp;\u0026plusmn;\u0026thinsp;21.77\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eALB, mean (SD), g/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e39.58\u0026thinsp;\u0026plusmn;\u0026thinsp;5.95\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e40.70\u0026thinsp;\u0026plusmn;\u0026thinsp;3.10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e40.09\u0026thinsp;\u0026plusmn;\u0026thinsp;4.67\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal triglyceride, median (IQR), mmol/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.96 (0.75, 1.26)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2.62 (1.00, 3.03)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1.10 (0.84, 2.83)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal cholesterol, mean (SD), mmol/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4.97\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6.46\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e5.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.38\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUrea, mean (SD), mmol/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7.82\u0026thinsp;\u0026plusmn;\u0026thinsp;2.92\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5.24\u0026thinsp;\u0026plusmn;\u0026thinsp;2.86\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6.64\u0026thinsp;\u0026plusmn;\u0026thinsp;3.06\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCreatinine, mean (SD), \u0026micro;mol/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e123.50\u0026thinsp;\u0026plusmn;\u0026thinsp;53.63\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e94.00\u0026thinsp;\u0026plusmn;\u0026thinsp;47.84\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e110.01\u0026thinsp;\u0026plusmn;\u0026thinsp;50.90\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUric Acid, mean (SD), \u0026micro;mol/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e383.67\u0026thinsp;\u0026plusmn;\u0026thinsp;109.04\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e355.00\u0026thinsp;\u0026plusmn;\u0026thinsp;175.22\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e370.64\u0026thinsp;\u0026plusmn;\u0026thinsp;135.83\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eeGFR, mean (SD), mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e54.82\u0026thinsp;\u0026plusmn;\u0026thinsp;16.96\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e82.92\u0026thinsp;\u0026plusmn;\u0026thinsp;35.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e67.59\u0026thinsp;\u0026plusmn;\u0026thinsp;29.23\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e24-hour proteinuria, mean (SD), g/day\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2.14\u0026thinsp;\u0026plusmn;\u0026thinsp;0.50\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUrinary RBC count (cells/\u0026micro;l), median (IQR)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e424.55 (70.10, 1403.60)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e87.20 (54.90, 372.95)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e121.60 (62.00, 641.30)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eACEI, angiotensin-converting enzyme inhibitor; ALB, albumin; ARBs, angiotensin receptor blockers; BMI, body mass index; CR, complete remission; eGFR, estimated glomerular filtration rate; IQR, interquartile range; PR, partial remission; RBC, red blood cell; SD, standard deviation; SGLT2, sodium-glucose cotransporter-2.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003ePrimary outcomes\u003c/h2\u003e\u003cdiv id=\"Sec12\" class=\"Section3\"\u003e\u003ch2\u003eEffects on Proteinuria\u003c/h2\u003e\u003cp\u003eSignificant proteinuria reduction was observed 12 weeks after initiating telitacicept, from 1.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78 g/24h to 0.93\u0026thinsp;\u0026plusmn;\u0026thinsp;0.62 g/24h for 24-hour proteinuria, with mean reduction of 45.53% (95% CI: 31.97\u003cb\u003e\u0026ndash;\u003c/b\u003e59.09, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). By week 24, the level of 24-hour proteinuria reduced to 0.60\u0026thinsp;\u0026plusmn;\u0026thinsp;0.40 g/24h, representing a reduction of 64.38% (95% CI: 55.56\u003cb\u003e\u0026ndash;\u003c/b\u003e73.21, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Similar to the trend observed in the full cohort, the level of 24-hour proteinuria in telitacicept 80 mg group at week 12 decreased from 1.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78 g/24h to 0.52\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32 g/24h, with mean decrease of 54.70% (95% CI: 34.19\u003cb\u003e\u0026ndash;\u003c/b\u003e75.72, p\u0026thinsp;=\u0026thinsp;0.001)), to 0.35\u0026thinsp;\u0026plusmn;\u0026thinsp;0.18 g/24h at week 24, with mean decrease of 68.67% (95% CI: 53.83\u003cb\u003e\u0026ndash;\u003c/b\u003e85.51, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). In telitacicept 160 mg group, the level of 24-hour proteinuria at week 12 decreased from 2.14\u0026thinsp;\u0026plusmn;\u0026thinsp;0.50 g/24h to 1.43\u0026thinsp;\u0026plusmn;\u0026thinsp;0.55 g/24h, with mean decrease of 34.53% (95% CI: 14.37\u003cb\u003e\u0026ndash;\u003c/b\u003e54.68, p\u0026thinsp;=\u0026thinsp;0.009), to 0.90\u0026thinsp;\u0026plusmn;\u0026thinsp;0.41 g/24h at week 24, with mean decrease of 59.24% (95% CI: 45.61\u003cb\u003e\u0026ndash;\u003c/b\u003e72.88, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). (Figs.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003ea, b).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eEffects on Estimated Glomerular Filtration Rate\u003c/h2\u003e\u003cp\u003eThe level of eGFR significantly improved from 67.59\u0026thinsp;\u0026plusmn;\u0026thinsp;29.23 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e to 74.77\u0026thinsp;\u0026plusmn;\u0026thinsp;28.56 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e at week 12, with mean absolute increase: 7.18\u0026thinsp;\u0026plusmn;\u0026thinsp;6.54 mL/min/1.73m\u0026sup2; and mean percentage increase of 12.60% (95% CI: 5.84\u003cb\u003e\u0026ndash;\u003c/b\u003e19.36, P\u0026thinsp;=\u0026thinsp;0.002), and further increased to 78.59\u0026thinsp;\u0026plusmn;\u0026thinsp;24.46 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e at week 24, with mean absolute increase: 11.00\u0026thinsp;\u0026plusmn;\u0026thinsp;12.16 mL/min/1.73m\u0026sup2; and mean percentage increase of 23.18% (95% CI: 8.60\u003cb\u003e\u0026ndash;\u003c/b\u003e37.76, P\u0026thinsp;=\u0026thinsp;0.005). Similar to the trend observed in the full cohort, eGFR at 12 weeks in telitacicept 80 mg group increased from 54.82\u0026thinsp;\u0026plusmn;\u0026thinsp;16.96 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e to 65.58\u0026thinsp;\u0026plusmn;\u0026thinsp;22.78 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e, with mean absolute increase: 10.76\u0026thinsp;\u0026plusmn;\u0026thinsp;6.81 mL/min/1.73m\u0026sup2; and mean percentage increase of 18.78% (95% CI: 9.78\u003cb\u003e\u0026ndash;\u003c/b\u003e27.78, p\u0026thinsp;=\u0026thinsp;0.003)), and 71.54\u0026thinsp;\u0026plusmn;\u0026thinsp;21.66 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e, with mean absolute increase: 16.72\u0026thinsp;\u0026plusmn;\u0026thinsp;8.67 mL/min/1.73m\u0026sup2; and mean percentage increase of 32.72% (95% CI: 15.58\u003cb\u003e\u0026ndash;\u003c/b\u003e49.85, p\u0026thinsp;=\u0026thinsp;0.004). In telitacicept 160 mg group, eGFR remained stable from 82.92\u0026thinsp;\u0026plusmn;\u0026thinsp;35.19 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e to 85.81\u0026thinsp;\u0026plusmn;\u0026thinsp;33.33 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e at week 12, with mean absolute increase: 2.89\u0026thinsp;\u0026plusmn;\u0026thinsp;2.58 mL/min/1.73m\u0026sup2; and mean percentage increase of 5.19% (95% CI: \u0026minus;\u0026thinsp;2.17\u003cb\u003e\u0026ndash;\u003c/b\u003e12.55, p\u0026thinsp;=\u0026thinsp;0.122), and 87.06\u0026thinsp;\u0026plusmn;\u0026thinsp;27.30 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e at week 24, with mean absolute increase: 4.14\u0026thinsp;\u0026plusmn;\u0026thinsp;12.95 mL/min/1.73m\u0026sup2; and mean percentage increase of 11.73% (95% CI: \u0026minus;\u0026thinsp;17.23\u003cb\u003e\u0026ndash;\u003c/b\u003e40.68, p\u0026thinsp;=\u0026thinsp;0.324). (Figs.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003ea, b).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eSecondary outcomes\u003c/h2\u003e\u003cdiv id=\"Sec15\" class=\"Section3\"\u003e\u003ch2\u003eEffects on Hematuria\u003c/h2\u003e\u003cp\u003eIn the whole telitacicept group, the urinary red blood cell (RBC) counts at 12 weeks decreased from 121.60 cells/\u0026micro;l (IQR 62.00\u0026ndash;641.30) to 59.60 cells/\u0026micro;l (IQR 26.20\u0026ndash;85.80) (P\u0026thinsp;=\u0026thinsp;0.004), to 34.60 cells/\u0026micro;l (IQR 22.20\u0026ndash;55.10) at week 24(P\u0026thinsp;=\u0026thinsp;0.003). In telitacicept 80 mg group, from 424.55 cells/\u0026micro;l (IQR 70.10\u0026ndash;1403.60) to 50.85 cells/\u0026micro;l (IQR 26.20\u0026ndash;307.13) at week 12 (P\u0026thinsp;=\u0026thinsp;0.028), to 33.30 cells/\u0026micro;l (IQR 13.53\u0026ndash;160.63) at week 24 (P\u0026thinsp;=\u0026thinsp;0.028). In telitacicept 160 mg group, from 87.20 cells/\u0026micro;l (IQR 54.90\u0026ndash;372.95) to 66.10 cells/\u0026micro;l (IQR 26.15\u0026ndash;179.55) at week 12 (P\u0026thinsp;=\u0026thinsp;0.080), to 38.60 cells/\u0026micro;l (IQR 23.70\u0026ndash;49.15) at week 24 (P\u0026thinsp;=\u0026thinsp;0.043). (Figs.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\u003ch2\u003eSteroid-Sparing Effect\u003c/h2\u003e\u003cp\u003eTelitacicept demonstrated a notable steroid-sparing effect. In our study, among the 4 patients using glucocorticoids, the mean dose decreased from 18.75 mg/d at baseline to 5.0 mg/d at the end of follow-up, representing 73.33% reduction in steroid dosage. In addition, 2 patients achieved complete steroid discontinuation.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\u003ch2\u003eTreatment efficacy\u003c/h2\u003e\u003cp\u003eAt the last follow-up of each patient, the whole telitacicept group had 7 patients who had achieved PR, 3 patients who had achieved CR and an overall efficacy rate of 90.91%. In the 80 mg telitacicept subgroup there were 3 patients who had achieved PR, 3 patients who had achieved CR and an overall efficacy rate of 100%. Similarly, in the 160 mg telitacicept group, there were 4 patients who had achieved PR, 0 patients who had achieved CR and an overall efficacy rate of 80%. (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eEfficacy rates of participants during each follow-up period.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGroup\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOverall efficacy rate,\u0026nbsp;n (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCR,\u0026nbsp;n (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePR,\u0026nbsp;n (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eIneffective,\u0026nbsp;n (%)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAll telitacicept (n\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10 (90.91)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (27.27)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7 (63.64)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1 (9.09)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTelitacicept 160 mg (n\u0026thinsp;=\u0026thinsp;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (80)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4 (80)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1 (20)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTelitacicept 80 mg (n\u0026thinsp;=\u0026thinsp;6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (50)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3 (50)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eCR, complete remission; PR, partial remission.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\u003ch2\u003eSafety and AEs\u003c/h2\u003e\u003cp\u003eDuring the follow-up periods, no SAEs were observed. In the whole telitacicept group, only 2 patients in 160 mg telitacicept subgroup experienced local skin reactions (incidence of AEs was 18.18%).\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eIgA nephropathy, classified as an autoimmune-related kidney disease, is characterized primarily by the deposition of galactose-deficient IgA within the glomerular mesangial area(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Conventional treatment strategies for IgA nephropathy are primarily based on supportive care, often combined with immunosuppressive therapy(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Studies have shown that the B-cell stimulatory factors B lymphocyte stimulator (BLyS/BAFF) and A Proliferation-Inducing Ligand (APRIL) can accelerate the progression of IgA nephropathy(\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eTelitacicept, a dual-target inhibitor blocking both APRIL and BLyS, also impacts the secretion of autoantibodies by plasma cells(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). This mechanism provides a rationale for its use in treating IgA nephropathy. The phase II telitacicept trial (NCT04291781; registered on February 28, 2020) have affirmed telitacicept\u0026rsquo;s efficacy and safety in IgA treatment(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), while further research must delineate its practical benefits in routine clinical applications.\u003c/p\u003e\u003cp\u003ePioneering the real-world assessment of low-to-medium dose telitacicept (80\u0026ndash;160 mg/week), this study reveals its efficacy in high-risk progressive IgAN adults refractory to conventional therapy. We observed a triad of renoprotective effects: rapid proteinuria decline (64.4%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), unprecedented eGFR elevation (+\u0026thinsp;23.2%, P\u0026thinsp;=\u0026thinsp;0.005), and significant hematuria resolution (71.5% RBC reduction)\u0026mdash;achieved with minimal toxicity. Notably, the 80 mg dose regimen achieved comparable efficacy to 160 mg in both proteinuria reduction (68.67% vs 59.23%) and eGFR improvement (+\u0026thinsp;32.72% vs\u0026thinsp;+\u0026thinsp;11.73%), mirroring dose-response patterns observed in lupus nephritis trials(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThis finding on lower-dose efficacy is of pivotal clinical importance when viewed in the context of accumulating real-world evidence. The compelling efficacy observed in our cohort is highly consistent with a recent study by Liu et al. in 16 pediatric patients (including 11 with IgAN), which reported a 79.12% reduction in 24-hour proteinuria at week 48 and a 62.5% complete remission rate(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). This convergence of findings across independent centers and age groups strengthens the validity of our results despite the sample size constraint. \u003cb\u003eFurthermore, while\u003c/b\u003e another large real-world study in adults by Weng et al. corroborated the proteinuria-reducing effect of telitacicept, \u003cb\u003eit utilized the conventional 240 mg dose\u003c/b\u003e(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). \u003cb\u003eThe comparable efficacy of our 80 mg regimen, therefore, presents a distinct and pragmatic advantage\u003c/b\u003e for chronic disease management. The potential for maintaining clinical efficacy while simultaneously minimizing drug exposure, reducing treatment costs, and potentially improving long-term safety positions this lower-dose strategy as a highly attractive and patient-centric therapeutic option.\u003c/p\u003e\u003cp\u003eThis study establishes that telitacicept provides rapid onset renoprotection in high-risk IgAN patients, with clinically significant proteinuria reduction and eGFR improvement emerging as early as Week 12. This early response offers a valuable therapeutic window for patients refractory to conventional therapies, enabling timely intervention before irreversible fibrosis develops. By Week 24, these benefits intensified\u0026mdash;demonstrating not only sustained efficacy but also progressive renal function recovery\u0026mdash;thereby supporting telitacicept's transition from short-term induction to long-term management in real-world practice.\u003c/p\u003e\u003cp\u003eAnother clinically significant observation was telitacicept's pronounced effect on hematuria, with urinary red blood cells decreasing by 71.54% at Week 24. This finding addresses an important therapeutic gap, as persistent hematuria independently predicts renal function decline in IgA nephropathy according to contemporary studies(\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), yet remains unaddressed in current management guidelines. Wang et al.(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) reported median RBC decrease from 35.40 to 13.60 cells/\u0026micro;L (61.58% decline) consistent directionally with our study, supporting mechanistic coherence. Confirmatory trials are warranted to establish hematuria as a validated response marker.\u003c/p\u003e\u003cp\u003eFurthermore, telitacicept exhibited significant steroid-sparing effects: glucocorticoid doses decreased by 73.33% overall, with 18.18% of patients achieving complete discontinuation. Crucially, even in the 4 patients receiving concomitant immunosuppressants, no additive immunosuppressive risks were observed, underscoring its favorable safety profile during combination therapy. These findings provide critical evidence for optimizing IgAN treatment paradigms through targeted biologics.\u003c/p\u003e\u003cp\u003eWhile our therapeutic outcomes align with the established efficacy trajectory of the phase II telitacicept trial (NCT04291781), enhanced renoprotection was observed\u0026mdash;characterized by superior proteinuria reduction (64.38% vs 38\u0026ndash;49%) and significant eGFR improvement (+\u0026thinsp;23.18% vs stabilization)\u0026mdash;likely attributable to two pivotal factors: 1) the high prevalence of treatment-responsive pathology (72.73% exhibiting crescents with regenerative potential), and 2) concomitant immunosuppression in refractory cases (36.37% receiving glucocorticoids\u0026thinsp;\u0026plusmn;\u0026thinsp;immunosuppressants, potentially amplifying efficacy though drug interactions require further elucidation).\u003c/p\u003e\u003cp\u003eThe favorable safety profile observed in our cohort\u0026mdash;characterized by only mild injection-site reactions (18.18%) and absence of serious infections\u0026mdash;is consistent with the established mechanism of Telitacicept, which has fewer side effects than conventional medications as it is metabolized intracellularly without hepatic/renal clearance(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eStudy limitations include the small sample size, absence of a parallel control group, and relevant short observational time, which was only 24 weeks. Future investigations should validate these findings in large-scale and long-term trial.\u003c/p\u003e\u003cp\u003eIn conclusion, low-to-medium dose telitacicept achieves rapid multisystem benefits in high-risk IgA nephropathy, contributing to reductions in proteinuria, increases in the eGFR, significantly reduces hematuria, and maintaining a favorable safety profile. The 80 mg regimen's non-inferior efficacy underscores its viability for chronic management, addressing critical unmet needs.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003ch2\u003eCONFLICT OF INTEREST STATEMENT\u003c/h2\u003e\u003cp\u003eThe author declares no conflicts of interest.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eFUNDING\u003c/h2\u003e\u003cp\u003eNone\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eY.L. and L.S. designed the study. J.P., X.X. collected the clinical data of patients. J.P. and X.X. performed statistical analyses. J.P. and X.X. drafted the manuscript. Y.L., L.S., X.S., X.C., J.Z., R.H., L.Y. and H.Z. checked and revised the article. All authors read and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eACKNOWLEDGEMENTS\u003c/h2\u003e\u003cp\u003eWe are grateful to all participants, the doctors, and nurses of the Nephrology department for their efforts and contributions to this research.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data underlying this article will be shared on reasonable request to the corresponding author.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHu R, Quan S, Wang Y, Zhou Y, Zhang Y, Liu L, et al. Spectrum of biopsy proven renal diseases in Central China: a 10-year retrospective study based on 34,630 cases. Sci Rep. 2020 Jul 3;10(1):10994.\u003c/li\u003e\n\u003cli\u003eFloege J, Barratt J. IgA nephropathy: a perspective for 2021. Semin Immunopathol. 2021 Oct 27;43(5):625\u0026ndash;6. \u003c/li\u003e\n\u003cli\u003eSuzuki H, Kiryluk K, Novak J, Moldoveanu Z, Herr AB, Renfrow MB, et al. The Pathophysiology of IgA Nephropathy. Journal of the American Society of Nephrology. 2011 Oct;22(10):1795\u0026ndash;803. \u003c/li\u003e\n\u003cli\u003eCao Y, Lu G, Chen X, Chen X, Guo N, Li W. BAFF is involved in the pathogenesis of IgA nephropathy by activating the TRAF6/NF‑\u0026kappa;B signaling pathway in glomerular mesangial cells. Mol Med Rep. 2019 Dec 6; \u003c/li\u003e\n\u003cli\u003eZhai YL, Zhu L, Shi SF, Liu LJ, Lv JC, Zhang H. Increased APRIL Expression Induces IgA1 Aberrant Glycosylation in IgA Nephropathy. Medicine. 2016 Mar;95(11):e3099. \u003c/li\u003e\n\u003cli\u003eLI W, PENG X, LIU Y, LIU H, LIU F, HE L, et al. TLR9 and BAFF: Their expression in patients with IgA nephropathy. Mol Med Rep. 2014 Sep;10(3):1469\u0026ndash;74. \u003c/li\u003e\n\u003cli\u003eShi F, Xue R, Zhou X, Shen P, Wang S, Yang Y. Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease. Immunopharmacol Immunotoxicol. 2021 Nov 2;43(6):666\u0026ndash;73. \u003c/li\u003e\n\u003cli\u003eLv J, Liu L, Hao C, Li G, Fu P, Xing G, et al. Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria. Kidney Int Rep. 2023 Mar 1;8(3):499\u0026ndash;506. \u003c/li\u003e\n\u003cli\u003eLe W, Liang S, Hu Y, Deng K, Bao H, Zeng C, et al. Long-term renal survival and related risk factors in patients with IgA nephropathy: results from a cohort of 1155 cases in a Chinese adult population. Nephrology Dialysis Transplantation. 2012 Apr 1;27(4):1479\u0026ndash;85. \u003c/li\u003e\n\u003cli\u003eTang C, Chen P, Si FL, Lv JC, Shi SF, Zhou XJ, et al. Time-Varying Proteinuria and Progression of IgA Nephropathy: A Cohort Study. American Journal of Kidney Diseases. 2024 Aug;84(2):170-178.e1. \u003c/li\u003e\n\u003cli\u003eFloege J, Rauen T, Tang SCW. Current treatment of IgA nephropathy. Semin Immunopathol. 2021 Oct 8;43(5):717\u0026ndash;28. \u003c/li\u003e\n\u003cli\u003eDhillon S. Telitacicept: First Approval. Drugs. 2021 Sep 31;81(14):1671\u0026ndash;5. \u003c/li\u003e\n\u003cli\u003eGao S, Yang C, Huang B, Yang L, Lu L, Yang H, et al. Comparative efficacy and safety of different recommended doses of telitacicept in patients with systemic lupus erythematosus in China: a systematic review and meta-analysis. Vol. 15, Frontiers in Immunology. Frontiers Media SA; 2024. \u003c/li\u003e\n\u003cli\u003eLiu J, Han X, Jiang X, Gao X, Li G, Fang X, et al. Efficacy and Safety of Telitacicept as an Add-On Therapy for Refractory Immunoglobulin A Nephropathy or Immunoglobulin A Vasculitis Nephropathy in Children. Kidney Int Rep. 2025 Mar 1;10(3):940\u0026ndash;3. \u003c/li\u003e\n\u003cli\u003eWeng Q, Ouyang Y, Chen Z, Jin Y, Xu J, Liu J, et al. Efficacy and safety of telitacicept in IgA nephropathy: Real-world study outcomes. Clin Kidney J. 2025 Jun 1;18(6). \u003c/li\u003e\n\u003cli\u003eHuang Z, Zhang J, Chen B, Li D, You X, Zhou Y, et al. Clinical Significance of Persistent Hematuria Degrees in Primary IgA Nephropathy: A Propensity Score-Matched Analysis of a 10-Year Follow-Up Cohort. Am J Nephrol. 2023 May 1;54(1\u0026ndash;2):62\u0026ndash;73. \u003c/li\u003e\n\u003cli\u003eYu G zhen, Guo L, Dong J feng, Shi S fang, Liu L jun, Wang J wei, et al. Persistent Hematuria and Kidney Disease Progression in IgA Nephropathy: A Cohort Study. American Journal of Kidney Diseases. 2020 Jul 1;76(1):90\u0026ndash;9. \u003c/li\u003e\n\u003cli\u003eHe P, Wang H, Huang C, He L. Hematuria was a high risk for renal progression and ESRD in immunoglobulin a nephropathy: a systematic review and meta-analysis. Ren Fail. 2021;43(1):488\u0026ndash;99. \u003c/li\u003e\n\u003cli\u003eWang M, Ma J, Yao L, Fan Y. Efficacy and safety of telitacicept, a BLyS/APRIL dual inhibitor, in the treatment of IgA nephropathy: A retrospective case-control study. Clin Kidney J. 2024 Oct 1;17(10). \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":"bmc-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bnep","sideBox":"Learn more about [BMC Nephrology](http://bmcnephrol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bnep/default.aspx","title":"BMC Nephrology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Telitacicept, IgA nephropathy, 24-hour urinary protein, glomerular filtration rate, urinary red blood cell count","lastPublishedDoi":"10.21203/rs.3.rs-7621514/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7621514/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective: \u003c/strong\u003eThe purpose of this study was to evaluate the efficacy and safety of low- to medium-dose (160 mg/W or 80 mg/W) telitacicept in adults at high risk of progression to IgA nephropathy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThis was a single-center retrospective study. The study included adults at high risk for progression of IgA nephropathy who were treated with telitacicept between November 2022 and April 2024 and followed for at least 24 weeks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eIn this study of 11 patients, telitacicept significantly reduced proteinuria by 64.38% (p \u0026lt; 0.001) and increased eGFR by 23.18% (p = 0.005) at week 24. Both the 80 mg and 160 mg dose groups demonstrated significant reductions in proteinuria (68.67% and 59.23%, respectively, both p \u0026lt; 0.001) and urinary RBC counts. The overall response rate was 90.91%. Telitacicept demonstrated a favorable safety profile, with only mild injection-site reactions reported (18.2%) and no serious adverse events.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eIn this real-world study, low- to medium-dose of telitacicept combined with conventional therapy showed rapid onset efficacy and safety for treating high-risk progressive IgA patients.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of Low- to Medium-Dose Telitacicept in Adults with High-Risk Progressive IgA Nephropathy: A Retrospective Real-World Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-17 17:49:28","doi":"10.21203/rs.3.rs-7621514/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-10-22T10:57:58+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-12T11:38:40+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-12T09:37:34+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"200230775211572931582079771823548395357","date":"2025-10-06T03:32:53+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"219005420505284273604766830843657742237","date":"2025-10-05T13:53:02+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-03T07:05:14+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-10-03T06:02:14+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-09-30T16:23:39+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-30T16:23:32+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Nephrology","date":"2025-09-15T14:05:28+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bnep","sideBox":"Learn more about [BMC Nephrology](http://bmcnephrol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bnep/default.aspx","title":"BMC Nephrology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"77399a39-7da0-4614-8c09-031d0dc368de","owner":[],"postedDate":"October 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-22T16:14:31+00:00","versionOfRecord":{"articleIdentity":"rs-7621514","link":"https://doi.org/10.1186/s12882-025-04708-w","journal":{"identity":"bmc-nephrology","isVorOnly":false,"title":"BMC Nephrology"},"publishedOn":"2025-12-17 15:57:23","publishedOnDateReadable":"December 17th, 2025"},"versionCreatedAt":"2025-10-17 17:49:28","video":"","vorDoi":"10.1186/s12882-025-04708-w","vorDoiUrl":"https://doi.org/10.1186/s12882-025-04708-w","workflowStages":[]},"version":"v1","identity":"rs-7621514","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7621514","identity":"rs-7621514","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}