BRIEF RESEARCH REPORT article
Front. Immunol.
Sec. Autoimmune and Autoinflammatory Disorders : Autoimmune Disorders
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1537334
The Effectiveness and Safety of Ofatumumab for the Treatment of Pemphigus Vulgaris: A Cohort Study Based on a Registry Database
Provisionally accepted
Xiwen Zhang
Yiyi WangPing TanMi WangXingli Zhou
Yue Xiao
Xun Feng
Jishu LiMintong WeiMin ZouGyeongah KimLu JiangXiaohong LiJinqiu Wang
Wei Li*- West China Hospital, Sichuan University, Chengdu, China
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Background: Ofatumumab, a fully human anti-CD20 monoclonal antibody administered subcutaneously and indicated for multiple sclerosis, might theoretically be effective for patients with pemphigus vulgaris (PV).Objective: To evaluate the effectiveness and safety of ofatumumab in patients with PV.Methods: This cohort study was based on a registry database of autoimmune bullous diseases at West China Hospital (AIBD-WCH), including two groups. One was ofatumumab (OFA) group, involving patients receiving ofatumumab subcutaneous injections (2´20mg, 2 weeks apart) and systemic glucocorticoids with/without immunosuppressant. The glucocorticoids control (GC) group was matched using propensity score matching in a 1:2 ratio based on sex, age and body mass index. Both groups completed regular follow-up for 52 weeks. The primary endpoint was the proportion of patients achieving complete remission during therapy (CRDT) at week 52. Secondary endpoints included maintaining treatment (MT) with daily prednisone doses <0.2 mg/kg/d, relapse rate, the change of PDAI and cumulative glucocorticoid doses. Safety results were also collected.Results: Sixteen and thirty-two patients were included in OFA and GC groups, respectively. At week 52, more patients in OFA group achieved CRDT (31.2% versus 3.12%, p=0.012) and MT (68.8% versus 25.0%, p=0.009). Furthermore, patients in OFA group took lower cumulative glucocorticoid doses by week 52 (6186 [SD: 1177]mg versus 9317 [SD: 1579]mg, p＜0.001). A patient in OFA group experienced gastric hemorrhage, which was judged to be unrelated to ofatumumab, while two in GC group developed lung infections.Conclusions: Ofatumumab combined with glucocorticoids demonstrated favorable effectiveness compared with GC group, without increasing severe adverse events.
Keywords: Pemphigus, therapy, Ofatumumab, CD20 monoclonal antibody, B cell depletion, biologics
Received: 30 Nov 2024; Accepted: 09 Jul 2025.
Copyright: © 2025 Zhang, Wang, Tan, Wang, Zhou, Xiao, Feng, Li, Wei, Zou, Kim, Jiang, Li, Wang and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Wei Li, West China Hospital, Sichuan University, Chengdu, China
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