{"title":"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","authors":"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","doi":"10.1093/mr/roaf052","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the efficacy and safety of rituximab (RTX) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) in Japan.</p><p><strong>Methods: </strong>Patients with MPA and GPA treated with RTX at each institution were enrolled and followed-up prospectively. Two years of data were analysed.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The effectiveness and safety of RTX for MPA and GPA in Japan were demonstrated over a 2-year observation period.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Nation-wide cohort study of Japanese patients with ANCA-associated vasculitis using rituximab: effectiveness and safety after two years.\",\"authors\":\"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\",\"doi\":\"10.1093/mr/roaf052\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To evaluate the efficacy and safety of rituximab (RTX) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) in Japan.</p><p><strong>Methods: </strong>Patients with MPA and GPA treated with RTX at each institution were enrolled and followed-up prospectively. Two years of data were analysed.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The effectiveness and safety of RTX for MPA and GPA in Japan were demonstrated over a 2-year observation period.</p>\",\"PeriodicalId\":18705,\"journal\":{\"name\":\"Modern Rheumatology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-06-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Modern Rheumatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/mr/roaf052\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Modern Rheumatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/mr/roaf052","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
Nation-wide cohort study of Japanese patients with ANCA-associated vasculitis using rituximab: effectiveness and safety after two years.
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.
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
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