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ORIGINAL RESEARCH article

Front. Immunol.

Sec. Autoimmune and Autoinflammatory Disorders : Autoimmune Disorders

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1624234

This article is part of the Research TopicCommunity Series: Systemic Vasculitis: Advances in Pathogenesis and Therapies Volume IIView all 4 articles

Reduced-Dose Obinutuzumab Induces Remission in Refractory ANCA-Associated Vasculitis: A Report of 16 Cases

Provisionally accepted
  • Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

The final, formatted version of the article will be published soon.

Rituximab remains the standard-of-care anti-CD20 therapy for ANCA-associated vasculitis (AAV).Obinutuzumab, a next-generation glycoengineered anti-CD20 monoclonal antibody with enhanced B-cell depleting capacity, may offer superior efficacy. We evaluated the efficacy and safety of reduced-dose obinutuzumab in 16 patients with refractory active AAV at a single centre in China.In this retrospective chart review, we evaluated 16 consecutive patients who received reduced-dose obinutuzumab (most commonly 1000 mg for induction) after failure to achieve remission with cyclophosphamide (CTX) and/or rituximab (RTX) or who presented with severe, treatment-naïve disease. Primary endpoints were complete remission (CR) rates at 24 and 76 weeks. Secondary endpoints included changes in renal function, inflammatory biomarkers and immune reconstitution.Adverse events were prospectively recorded.Median age at obinutuzumab initiation was 44.5 years (IQR 31-54.3); 10 (62.5 %) were male. Mean Birmingham Vasculitis Activity Score (BVAS) was 13.5 ± 6.4. Twelve patients (75%) had relapsing disease refractory to CTX/RTX, while four treatment-naïve patients presented with multi-organ failure.CR was achieved in 8/16 (50 %) at week 24 and 13/16 (81.3 %) at week 76. Obinutuzumab induced rapid clinical remission, suppressed systemic inflammation, achieved peripheral B-cell depletion, rendered ANCA-negative, and improved renal and pulmonary outcomes. No severe infections occurred.Seven patients (43.8%) developed treatment-emergent infections, predominantly respiratory (75%).Reduced-dose obinutuzumab demonstrates sustained remission in refractory or relapsing active AAV, achieving high long-term remission rates with an acceptable safety profile. No severe invasive infections were observed.Reduced-dose obinutuzumab induced sustained remission in patients with relapsed or refractory ANCA-associated vasculitis.

Keywords: ANCA-associated vasculitis, Obinutuzumab, efficacy, Safety, B cell

Received: 08 May 2025; Accepted: 12 Aug 2025.

Copyright: © 2025 Wu, Juan and Chen. 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: Sheng Chen, Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

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