Dupilumab for the treatment of cutaneous graft-versus-host disease: a systematic review and individual patient data meta-analysis

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Data may be preliminary. 28 May 2025 V1 Latest version Share on Dupilumab for the treatment of cutaneous graft-versus-host disease: a systematic review and individual patient data meta-analysis Authors : Filippo Consonni 0000-0002-6879-8982 [email protected] , Linda Zollo , Giuseppina Calise , Cesare Filippeschi , Stefano Frenos , Teresa Oranges , Greta Tronconi 0009-0007-7839-1848 , Veronica Tintori , and Eleonora Gambineri Authors Info & Affiliations https://doi.org/10.22541/au.174843010.06975280/v1 Published Transplantation and Cellular Therapy Version of record Peer review timeline 196 views 80 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: Graft-versus-host disease (GvHD) remains a challenging complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), especially in steroid-refractory cases. Dupilumab, a monoclonal antibody targeting IL-4Rα and inhibiting Th2-mediated inflammation, has recently emerged as a potential off-label treatment for cutaneous GvHD with atopic dermatitis (AD)-like features. However, comprehensive evidence on its use in this setting is limited. Methods: We conducted a systematic review following PRISMA guidelines (PROSPERO ID: CRD420250654155) to evaluate the efficacy and safety of dupilumab in cutaneous GvHD. Eligible studies included case reports and case series involving pediatric or adult patients treated with dupilumab after allo-HSCT. Data on patient characteristics, treatment regimens, clinical outcomes, and adverse events were extracted and analyzed descriptively. Individual patient data were pooled for a subset analysis. Results: Nine studies (6 case series, 3 case reports) encompassing 18 patients were included. Most patients (72%) were pediatric and affected by non-malignant disorders. Dupilumab was used after multiple prior therapies, with variable dosing regimens, especially in children. The overall response rate was 95%, with a complete response in 56% of cases, particularly in AD-like GvHD, while a partial response was obtained in two patients with sclerotic cutaneous chronic GvHD. Dupilumab was well tolerated, with no drug-related toxicities reported. Conclusions: Dupilumab appears to be a promising, well-tolerated option for steroid-refractory cutaneous GvHD, especially with AD-like features. Its use may reduce immunosuppressive burden and improve quality of life. These findings support the need for prospective studies and randomized trials to define its role and optimal use in GvHD management. TITLE PAGE Title: Dupilumab for the treatment of cutaneous graft-versus-host disease: a systematic review and individual patient data meta-analysis Authors: Filippo Consonni 1,2* (ORCID: 0000-0002-6879-8982) , Linda Zollo 3 , Giuseppina Calise 3 , Cesare Filippeschi 4 , Stefano Frenos 2 , Teresa Oranges 4 ( ORCID: 0000-0002-7277-3278), Greta Tronconi 4 , Veronica Tintori 2 and Eleonora Gambineri 2,5 (ORCID: 0000-0002-4676-6541). 1 Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence, Italy 2 Division of Pediatric Oncology/Hematology, Bone marrow transplant Unit, Meyer Children’s Hospital IRCCS, Florence, Italy 3 Department of Health Sciences, University of Florence, Florence, Italy 4 Dermatology Unit, Meyer Children’s Hospital IRCCS, Florence, Italy 5 Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy *Correspondence: Filippo Consonni, MD Bone Marrow Transplant Unit, Department of Pediatric Hematology/Oncology Meyer Children’s Hospital IRCCS, Viale Gaetano Pieraccini 24, 50139 Firenze, Italy +39 055 566 2606, [email protected] Keywords: dupilumab, graft-versus-host disease, hematopoietic stem cell transplantation, children, atopic dermatitis Running title: Dupilumab in cutaneous GvHD Word count: 3150 words Tables and figures (main text): 4 tables, 2 figures Electronic repository: 2 tables i. CONFLICTS OF INTEREST STATEMENT All authors declare that they have no conflicts of interest to disclose. ii. FINANCIAL SUPPORT This study was supported in part by funds from the “Current Research Annual Funding” of the Italian Ministry of Health. iii.a. ABSTRACT (250 words) Background: Graft-versus-host disease (GvHD) remains a challenging complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), especially in steroid-refractory cases. Dupilumab, a monoclonal antibody targeting IL-4Rα and inhibiting Th2-mediated inflammation, has recently emerged as a potential off-label treatment for cutaneous GvHD with atopic dermatitis (AD)-like features. However, comprehensive evidence on its use in this setting is limited. Methods: We conducted a systematic review following PRISMA guidelines (PROSPERO ID: CRD420250654155) to evaluate the efficacy and safety of dupilumab in cutaneous GvHD. Eligible studies included case reports and case series involving pediatric or adult patients treated with dupilumab after allo-HSCT. Data on patient characteristics, treatment regimens, clinical outcomes, and adverse events were extracted and analyzed descriptively. Individual patient data were pooled for a subset analysis. Results: Nine studies (6 case series, 3 case reports) encompassing 18 patients were included. Most patients (72%) were pediatric and affected by non-malignant disorders. Dupilumab was used after multiple prior therapies, with variable dosing regimens, especially in children. The overall response rate was 95%, with a complete response in 56% of cases, particularly in AD-like GvHD, while a partial response was obtained in two patients with sclerotic cutaneous chronic GvHD. Dupilumab was well tolerated, with no drug-related toxicities reported. Conclusions: Dupilumab appears to be a promising, well-tolerated option for steroid-refractory cutaneous GvHD, especially with AD-like features. Its use may reduce immunosuppressive burden and improve quality of life. These findings support the need for prospective studies and randomized trials to define its role and optimal use in GvHD management. iii.b. KEYWORDS Dupilumab, graft-versus-host disease, hematopoietic stem cell transplantation, children, atopic dermatitis iv. MAIN TEXT INTRODUCTION Graft-versus-host disease (GvHD) remains a significant complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT), impacting morbidity and mortality independently of relapse. GvHD affects 40-60% of HSCT recipients, accounting for approximately 15% of post-transplant deaths. It manifests in acute and chronic forms, typically occurring within the first 100 days or after 100 days post-transplant, respectively. Acute GvHD (aGvHD) primarily affects the skin, gastrointestinal tract, and liver, while chronic GvHD’s (cGvHD) presentation is more variable, and the distinction between these forms is becoming less defined. Systemic corticosteroids are the standard first-line treatment for both acute and chronic GvHD; however, only about half of patients achieve a durable remission, highlighting the need for alternative therapeutic strategies(1,2). Management of aGvHD varies with severity. Grade I may respond to topical steroids or calcineurin inhibitors, but systemic intervention is needed if this is insufficient. Grade II-IV requires systemic corticosteroids (typically methylprednisolone 1-2 mg/kg/day). While in cases of steroid-refractory GVHD, several second-line therapeutic strategies are available, ruxolitinib has emerged as a preferred option due to its efficacy across multiple organ systems. For lower gastrointestinal involvement, anti-TNFα agents such as infliximab may be considered. Other approaches include sirolimus, anti-thymocyte globulin (ATG) or alemtuzumab, mesenchymal stromal cell infusions, and extracorporeal photopheresis (ECP)(3). The pathogenesis of GvHD is complex and involves dysregulation of T-cell effector mechanisms(1). While the traditional Th1/Th2 paradigm has become less defined, the identification of Th2-related immune responses in inflammatory skin diseases—and the clinical and histological similarities between chronic GvHD and atopic dermatitis (AD) —have encouraged exploration of therapies targeting this pathway(4). Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha subunit (IL-4Rα), inhibits IL-4 and IL-13 signaling, which are key cytokines involved in type 2 (Th2) inflammation. In cutaneous GvHD, eosinophilic infiltration and Th2-type immune activation are often prominent, resembling what is observed in AD. Dupilumab has demonstrated the ability to downregulate Th2 markers, reduce dermal cellular infiltrate, and improve skin barrier function in patient-derived samples. The drug is currently approved for conditions such as asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. Given its favorable safety profile, dupilumab has recently been employed off-label in other indications, including various inborn errors of immunity with a severe atopic phenotype(5,6), as well as cancer immunotherapy(7,8) and in cases of cutaneous GvHD refractory to multiple lines of treatment(9–17). The results in the GvHD setting appear highly promising; however, large-scale reviews and meta-analyses are still lacking, despite their importance in helping clinicians evaluate this therapy and weigh its benefits against potential adverse events. Herein, we report the results of a systematic review of all published cases of dupilumab use for cutaneous acute or chronic GvHD in both pediatric and adult patients undergoing allo-HSCT. Literature search This systematic review was carried out in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines(18) and was registered in the PROSPERO database under the ID CRD420250654155. A comprehensive literature search was performed using PubMed and Embase to identify relevant publications up to March 2025. The search strategy included the terms: (dupilumab) AND (graft versus host disease OR graft-versus-host disease OR GvHD OR aGvHD OR cGvHD) and was limited to articles in English involving adult or pediatric patients with cutaneous GvHD treated with dupilumab following allo-HSCT. Studies of any design were considered eligible. Two independent reviewers (L.Z. and G.C.) screened the titles and abstracts for potential relevance and subsequently evaluated the full texts of selected articles. A manual search of reference lists from included studies and relevant reviews was also conducted (snowballing method) to identify any additional eligible reports. Discrepancies in study selection were resolved through discussion and mutual agreement. If a consensus could not be reached, a third reviewer (F.C.), blinded to the initial decisions, was consulted to provide the final judgment. Data extraction (selection and coding) Data extraction followed the same standardized procedure and was independently conducted by the same two reviewers (G.C. and L.Z.), with oversight from a third investigator (F.C.). All studies reporting on patients of any age who received dupilumab for cutaneous GvHD were considered, in accordance with the predefined inclusion and exclusion criteria of the review. Information collected included details on dupilumab administration, clinical response, and reported adverse events, in both acute and chronic GvHD settings. The extracted data were organized using Microsoft Excel 2013 (Microsoft Corp., Redmond, WA), and visual representations were created using Microsoft PowerPoint 2013 for Windows and GraphPad Prism version 10.0 (GraphPad Software, San Diego, CA). Quality assessment Two reviewers (G.C. and L.Z.) independently assessed the quality of the included studies, resolving any disagreements through discussion until consensus was achieved. The methodological quality of case reports and case series was evaluated using the Joanna Briggs Institute (JBI) Critical Appraisal Checklists, tailored to the respective study design. The case report checklist includes eight criteria covering aspects such as patient background, clinical presentation, diagnostic process, therapeutic approach, treatment outcomes, follow-up details, and ethical considerations. For case series, ten criteria are considered, focusing on elements like inclusion criteria, consistency in patient selection, outcome measurement, and follow-up adequacy. Each domain is rated as “Yes,” “No,” “Unclear,” or “Not applicable.” Although a formal scoring system is not defined, studies with a higher number of affirmative (“Yes”) responses were considered to demonstrate greater methodological soundness. For descriptive categorization, studies were classified as low (0–3 “Yes” for case reports; 0–4 for case series), moderate (4–6 for case reports; 5–7 for case series), or high quality (7–8 for case reports; 8–10 for case series). Analysis of subgroups or subsets We conducted a qualitative synthesis to assess the effectiveness and safety profile of dupilumab in patients with acute and chronic graft-versus-host disease, including both pediatric (18 years) populations. A quantitative meta-analysis was feasible only for limited data due to the small number of patients and the heterogeneity of the available studies. Individual-level data from case reports and case series were pooled and analyzed to generate a descriptive overview of clinical outcomes. When not explicitly stated in the text, GvHD grading was inferred from the clinical case description, based on internationally standardized grading systems for GvHD(1,19). The key outcomes evaluated included overall response rate (ORR), complete response (CR), partial response (PR), non-response (NR), treatment failure (TF), time to response (TTR), and time to complete response (TTCR). CR was defined as complete resolution of GvHD symptoms, PR as clinical improvement without progression in other organ systems, NR as the absence of improvement or worsening symptoms, and TF as the discontinuation of dupilumab due to adverse events. To better characterize treatment patterns and outcomes, we also stratified results by age group, GvHD phenotype (e.g., AD-like vs. sclerotic), and dupilumab dosing regimen (presence or absence of loading dose; maintenance dose schedule). Graphical visualizations were used to illustrate response distributions, time to response, and dosing variability, thereby enhancing interpretability despite the small cohort size. Statistical analyses Statistical analyses were conducted using GraphPad Prism version 10.0 (GraphPad Software, San Diego, CA). The distribution of metric variables was assessed for normality. Continuous data were reported as medians with corresponding ranges. Comparisons between two groups were performed using the Student’s t-test for normally distributed variables and the Mann–Whitney U test for non-normally distributed data. For comparisons involving more than two groups, the Kruskal–Wallis test was applied. Categorical data were presented as absolute numbers and percentages and evaluated using either the chi-square test or Fisher’s exact test, depending on data characteristics. A p-value below 0.05 was considered indicative of statistical significance. RESULTS Literature search The literature search identified a total of 32 references (9 from PubMed and 23 from Embase). After deduplication, 7 articles were excluded, leaving 25 unique records. Based on full-title screening and on article type, 15 additional papers were excluded: 8 were review articles, 2 were conference abstracts, 5 did not mention GvHD. Of the 10 full-text articles assessed for eligibility, one was excluded since it did not mention GvHD, resulting in a final inclusion of 9 studies in the review ( Figure 1 ). Of the 9 included studies, 6 were case series and 3 were case reports. One of the case series(12) included 2 patients, only one of whom underwent allo-HSCT (the other underwent autologous hematopoietic stem cell gene therapy and was therefore excluded from this review). Five studies enrolled pediatric patients, while four included only adults. Seven papers included patients with AD-like acute or chronic GvHD, one described sclerotic cutaneous GvHD(16), and one did not specify the subtype of cutaneous GvHD(12). The quality of the included studies was evaluated according to the criteria outlined in the Methods section and is summarized in Table 1 . Descriptive analysis Dupilumab administration Dupilumab administration showed significant differences among the selected articles. A loading dose was administered only in 4 studies. Loading and maintenance doses were highly variable across included studies. Information about body weight was available in only one paper(15), so no clear correlations between patients’ weight and dupilumab dose used could be analyzed. In most of the included studies, dupilumab treatment was still ongoing at the time of publication ( Table 1 ). Response in acute and chronic cutaneous GvHD All included studies described patients with cutaneous GvHD refractory to previous treatments, which were both topical and systemic in 7 studies, only systemic in one study(13), and not specified in one paper(16) ( Table 1 ). Skin involvement severity was assessed using various scoring systems. The Investigator Global Assessment (IGA) scale was used in three studies(9,11,14), while the Dermatology Life Quality Index (DLQI) was applied in two articles(11,13). Additional scoring systems were each used in individual studies, including the Eczema Area and Severity Index (EASI)(11), Patient-Oriented Eczema Measure (POEM)(13), Atopic Dermatitis Control Tool (ADCT)(13), SCORing Atopic Dermatitis (SCORAD)(13), and the Pediatric Quality of Life Inventory (PedsQL)(12). Responses in acute and chronic GvHD are summarized in Table 2 and Table 3 , respectively. For acute GvHD, two articles reported an ORR of 100%, while one reported an ORR of 67%. TTR ranged from 1 to 3 months, and TTCR from 3 to 6 months. One case of dupilumab treatment failure in acute GvHD was described by Larjani et al.(9). For chronic GvHD, all selected papers reported an ORR of 100%, including patients with severe disease and two cases of sclerotic cGvHD reported by Mital et al.(16). In four articles, one or more patients experienced only a partial response to dupilumab. TTR ranged from 1 week to 11 months, while TTCR ranged from 1 week to 3 months. No cases of dupilumab treatment failure in cGvHD were reported in the included studies. Toxicities No adverse effects related to dupilumab use were reported in the included papers. In one case(9), a patient developed GvHD-associated myositis, which led to the reintroduction of steroids and ruxolitinib, as well as a dose reduction of dupilumab. No deaths occurred. Single-patient analysis Patients Single-patient data were available for 18 individuals across 9 studies. Key patient, disease, and transplant characteristics are summarized in Table 4 . The median age was 5 years (range 1–23); 13 patients (72%) were under 18 years of age, while 5 (28%) were adults. Thirteen patients (72%) underwent HSCT for non-malignant disorders, the most common of which were Mucopolysaccharidosis Type I-H (MPS-IH, Hurler’s disease; 4 patients), Wiskott-Aldrich Syndrome (WAS; 3 patients), and Severe Aplastic Anemia (SAA; 3 patients). A clinical history of atopy was reported in 4 patients (22%), including one case of allergic rhinitis. Most patients received myeloablative conditioning regimens (10/18, 56%). A relative majority underwent transplantation from a mismatched unrelated donor (MMUD; 7/18, 39%), and peripheral blood stem cells represented the most used stem cell source (8/18, 44%). GvHD and associated treatments All patients had GvHD as per inclusion criteria of this systematic review: 8/18 (44%) had aGvHD, while 12/18 (67%) had cGvHD. Notably, two patients who initially developed aGvHD were treated with dupilumab only after the onset of cGvHD. GvHD characteristics and treatments are summarized in Supplementary Table 1 . Extra-cutaneous GvHD involvement was reported in one case of aGvHD (ocular) and one case of cGvHD (pulmonary). Six cases of aGvHD and ten cases of cGvHD presented with AD-like features, making this the most frequent subtype of cutaneous GvHD. The most reported severity grades were grade I–II for aGvHD (5 patients) and moderate cGvHD (6 patients). Sixteen patients (89%) had received prior treatment for GvHD (data were not available for the remaining two cases(16)). The median number of previous lines of treatment (including topical agents) was 3.5 (range 2-7) and the most frequently employed GvHD treatments were calcineurin inhibitors (15/18, 83%), topical immunosuppressants (15/18, 83%) and systemic steroids (10/18, 56%). Dupilumab administration, response and toxicities Characteristics of dupilumab administration are summarized in Supplementary Table 2 . Six patients (33%) received a loading dose of dupilumab. In adults, the loading dose—when administered—was 600 mg, while in children it was 300 mg in 1 patient, 400 mg in 2 patients, and 600 mg in 1 case ( Figure 2A–B ). Similarly, the maintenance dose in adults, when specified, was consistently 300 mg every 2 weeks, whereas in children it was highly variable, with 300 mg every 4 weeks being the most used schedule ( Figure 2C–D ). ORR in all patients was 17/18 (95%): 10/18 (56%) of patients achieved a CR (of note, all of them were AD-like GvHD), while a PR was achieved in 7/18 (39%). In both cases of sclerotic cGvHD(16), dupilumab induced a PR ( Figure 2E–F ). Only one child with AD-like GvHD failed to respond to dupilumab(9). The rates of CR and PR in children (8/13, 61% and 4/13, 31%, respectively) did not significantly differ from those observed in adults (2/5, 40% and 3/5, 60%, respectively) ( Figure 2G–H ). Median time to response (TTR) was 1 month (range 0.25–11), and median time to complete response (TTCR) was 2 months (range 0.25–6); both were similar and did not significantly differ between aGvHD and cGvHD ( Supplementary Figure 1 ). Finally, as previously stated, no toxicities clearly attributable to dupilumab were reported. DISCUSSION Dupilumab is now widely used for the treatment of moderate to severe AD(20), and an increasing number of reports have documented its use in the post-HSCT setting for GvHD with AD-like features. Based on this emerging evidence, we conducted a systematic review and individual patient data meta-analysis to provide the first comprehensive synthesis of available data on the use of dupilumab for cutaneous GvHD in both pediatric and adult populations undergoing allo-HSCT. All included studies were case reports or case series, thus only low-quality evidence can currently be extracted from the literature. This underscores the urgent need for prospective studies, including randomized controlled trials, to generate more robust data on the efficacy and safety of dupilumab in GvHD. The patient population was highly heterogeneous. Notably, most reports involved children with non-malignant disorders. These included diseases intrinsically associated with eczema, such as WAS(21), where dupilumab has already shown efficacy in the pre-transplant setting, and other IEIs with atopic features(5,6). A substantial proportion of patients were also affected by MPS-IH (Hurler syndrome), a condition that may involve skin manifestations, although not typically eczema(22). Dupilumab was always administered after multiple prior treatments for both acute and chronic GvHD. No studies investigated its prophylactic use, even in patients with known atopic predisposition. Its potential role in GvHD prophylaxis remains unexplored and warrants further investigation, similar to what has been done for other monoclonal antibodies(23). Our analysis, despite the small sample size, indicates a high ORR of 94%, with a CR rate of 56%, consistent across age groups. While the majority of patients had AD-like GvHD, dupilumab was also employed in two cases of sclerotic cGvHD, achieving PR(16), suggesting potential benefit even in this severely disabling manifestation. These results are in line with those reported for ruxolitinib, which has been widely used in steroid-refractory acute and cGvHD, with ORRs ranging from 50% to 70% in children and adults(24,25). However, given the limited evidence based solely on case reports and series, a direct comparison of response rates between ruxolitinib and dupilumab is not feasible. Nonetheless, dupilumab appears to be a promising option not only for steroid-refractory cases but also in some instances of ruxolitinib-refractory GvHD, as five patients in our meta-analysis received ruxolitinib prior to dupilumab. It is important to note, however, that while ruxolitinib is often used successfully for extracutaneous GvHD, only two patients in this review had extracutaneous involvement, and outcomes beyond the skin were not adequately described. Thus, current evidence supports the use of dupilumab specifically for cutaneous GvHD. Mechanistically, the clinical and histopathological overlap between cutaneous GvHD and AD — both driven by Th2 inflammation —provides a strong rationale for targeting IL-4 and IL-13 with dupilumab. Importantly, dupilumab enabled discontinuation of systemic immunosuppressants in several pediatric patients, suggesting its potential as a steroid-sparing agent. Additionally, the absence of adverse events attributed to dupilumab in this meta-analysis reinforces its favorable safety profile. Nonetheless, the small sample size and case-based nature of the data may have limited the detection of relatively common side effects, such as conjunctivitis, reported in about 10% of pediatric patients treated with dupilumab for AD(20). Regarding dosing, adult regimens were consistent with previous studies(26), employing a 600 mg loading dose followed by 300 mg every two weeks. In contrast, dosing schedules in pediatric patients were highly variable. Although a recent pharmacokinetic and exposure–response study recommended a weight-tiered approach (300 mg every 4 weeks for 15–30 kg; 200 mg every 2 weeks for 30–60 kg; 300 mg every 2 weeks for >60 kg)(27), analysis of the application of this scheme was limited by the frequent absence of weight data in the included reports. Notably, one study used a non-standard regimen of 300 mg every 3 weeks(9), highlighting the need for clearer guidance on pediatric dosing in this context. Despite encouraging results, this systematic review and meta-analysis has several limitations. First, the reliance on case reports and small series introduces publication bias and limits generalizability. Second, variability in dosing regimens hampers interpretation of efficacy data. Third, standardized outcome measures for skin disease severity (e.g., EASI, POEM, SCORAD) were inconsistently applied, preventing objective cross-study comparisons. Furthermore, long-term follow-up data were sparse or absent, limiting assessment of treatment durability and relapse rates. Nevertheless, our findings provide a compelling signal of dupilumab’s efficacy and safety, supporting further exploration of its role in acute and chronic GvHD. Future prospective, randomized trials are urgently needed to confirm these observations, refine optimal dosing and treatment duration, and compare dupilumab with existing therapies such as ruxolitinib. In parallel, the adoption of standardized clinical scoring systems for post-HSCT skin disease would improve evaluation and comparability of treatment outcomes. In conclusion, current evidence suggests that dupilumab is a promising and well-tolerated treatment option for steroid-refractory cutaneous GvHD, particularly in cases with AD-like features. Its use may reduce steroid dependence, improve inflammation control, and enhance quality of life, especially in pediatric populations. However, broader clinical implementation will require validation in larger, controlled trials with standardized outcome reporting and long-term monitoring. v. ACKNOWLEDGMENTS None. vi. KEY MESSAGE Dupilumab shows high response rates and excellent tolerability in cutaneous graft-versus-host disease (GvHD), especially in pediatric patients with atopic dermatitis-like features. 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Kamal MA, Kovalenko P, Kosloski MP et al. The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis. Clin Pharmacol Ther 2021: 110 :1318–1328. viii. FIGURE LEGENDS Figure 1. Literature review process Figure 2. Distribution of dupilumab loading and maintenance dose according to age groups (A-D). Response rates to dupilumab according to GvHD subtype (E-F) and age groups (G-H). ix. DATA ACCESSIBILITY The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request. Supplementary Material File (tables_fc_21.05.2025.docx) Download 43.53 KB Information & Authors Information Version history V1 Version 1 28 May 2025 Peer review timeline Published Transplantation and Cellular Therapy Version of Record 1 Dec 2025 Published Copyright This work is licensed under a Non Exclusive No Reuse License. Authors Affiliations Filippo Consonni 0000-0002-6879-8982 [email protected] Universita degli Studi di Firenze Dipartimento di Scienze Biomediche Sperimentali e Cliniche Mario Serio View all articles by this author Linda Zollo Universita degli Studi di Firenze Dipartimento di Scienze della Salute View all articles by this author Giuseppina Calise Universita degli Studi di Firenze Dipartimento di Scienze della Salute View all articles by this author Cesare Filippeschi Azienda Ospedaliero Universitaria Meyer View all articles by this author Stefano Frenos Azienda Ospedaliero Universitaria Meyer View all articles by this author Teresa Oranges Azienda Ospedaliero Universitaria Meyer View all articles by this author Greta Tronconi 0009-0007-7839-1848 Azienda Ospedaliero Universitaria Meyer View all articles by this author Veronica Tintori Azienda Ospedaliero Universitaria Meyer View all articles by this author Eleonora Gambineri Azienda Ospedaliero Universitaria Meyer View all articles by this author Metrics & Citations Metrics Article Usage 196 views 80 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Filippo Consonni, Linda Zollo, Giuseppina Calise, et al. 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