Nation-wide cohort study of Japanese patients with ANCA-associated vasculitis using rituximab: effectiveness and safety after two years.

IF 1.9 4区医学 Q3 RHEUMATOLOGY

Modern Rheumatology Pub Date : 2025-06-09 DOI:10.1093/mr/roaf052

Kenji Nagasaka, Koichi Amano, Hiroko Nagafuchi, Ken-Ei Sada, Yoshinori Komagata, Masahiro Yamamura, Masaru Kato, Tomomi Endo, Izaya Nakaya, Tsutomu Takeuchi, Yohko Murakawa, Takahiko Sugihara, Masaya Saito, Taichi Hayashi, Shunsuke Furuta, Kazunori Karasawa, Shogo Banno, Shuichiro Endo, Masako Majima, Hiroaki Dobashi, Shinya Kaname, Naoto Tamura, Yoshiriro Arimura, Masayoshi Harigai

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引用次数: 0

Abstract

Objectives: To evaluate the efficacy and safety of rituximab (RTX) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) in Japan.

Methods: Patients with MPA and GPA treated with RTX at each institution were enrolled and followed-up prospectively. Two years of data were analysed.

Results: Seventy-five patients were received RTX for remission induction therapy and 57 were observed beyond 6 months. Thirty-five did and 22 did not receive any additional RTX treatment. RTX dosing patterns were diverse. During the 2-year observation period, 56 (74.7%) patients achieved remission; however, 11 (19.6%) patients relapsed. Five patients experienced major relapses, three experienced minor relapses, and three experienced unclassified relapses. Of the 75 patients treated with RTX as remission induction therapy, 63 severe adverse events (SAEs) were observed in 33 patients during the 2-year observation period. Thirty-nine SAEs occurred by 6 months and 24 SAEs were observed after 6 months. Of the 12 patients with SAEs after 6 months, four received RTX after 6 months, resulting in six events. The most common SAE was infection during the first six months and after six months.

Conclusions: The effectiveness and safety of RTX for MPA and GPA in Japan were demonstrated over a 2-year observation period.

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日本anca相关性血管炎患者使用利妥昔单抗的全国性队列研究：两年后的有效性和安全性

目的：评价利妥昔单抗（RTX）在日本治疗显微多血管炎（MPA）和肉芽肿性多血管炎（GPA）的疗效和安全性。方法：对各医院接受RTX治疗的MPA和GPA患者进行前瞻性随访。分析了两年的数据。结果：75例患者接受RTX缓解诱导治疗，57例患者观察超过6个月。35人接受了RTX治疗，22人没有接受任何额外的RTX治疗。RTX给药模式多种多样。在2年的观察期内，56例（74.7%）患者获得缓解；然而，11例（19.6%）患者复发。5例重度复发，3例轻度复发，3例未分类复发。在75例RTX作为缓解诱导治疗的患者中，在2年的观察期内，有33例患者出现了63例严重不良事件（sae）。6个月时发生39例，6个月后发生24例。在12例6个月后发生SAEs的患者中，4例6个月后接受了RTX治疗，导致6例事件。最常见的SAE是前6个月和6个月后的感染。结论：在日本，RTX治疗MPA和GPA的有效性和安全性在2年的观察期得到证实。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Modern Rheumatology RHEUMATOLOGY-

CiteScore

4.90

自引率

9.10%

发文量

146

审稿时长

1.5 months

期刊介绍： Modern Rheumatology publishes original papers in English on research pertinent to rheumatology and associated areas such as pathology, physiology, clinical immunology, microbiology, biochemistry, experimental animal models, pharmacology, and orthopedic surgery. Occasional reviews of topics which may be of wide interest to the readership will be accepted. In addition, concise papers of special scientific importance that represent definitive and original studies will be considered. Modern Rheumatology is currently indexed in Science Citation Index Expanded (SciSearch), Journal Citation Reports/Science Edition, PubMed/Medline, SCOPUS, EMBASE, Chemical Abstracts Service (CAS), Google Scholar, EBSCO, CSA, Academic OneFile, Current Abstracts, Elsevier Biobase, Gale, Health Reference Center Academic, OCLC, SCImago, Summon by Serial Solutions