イハラ　トシコ   Toshiko Ito-Ihara   猪原　登志子    所属   川崎医科大学  医学部 応用医学　先端医療開発学    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Rituximab versus azathioprine for maintenance of remission for patients with ANCA-associated vasculitis and relapsing disease: an international randomised controlled trial.
掲載誌名	正式名：Annals of the rheumatic diseases 略　 称：Ann Rheum Dis ISSNコード：14682060/00034967
掲載区分	国外
巻・号・頁	82(7),pp.937-944
著者・共著者	Rona M Smith, Rachel B Jones, Ulrich Specks, Simon Bond, Marianna Nodale, Reem Al-Jayyousi, Jacqueline Andrews, Annette Bruchfeld, Brian Camilleri, Simon Carette, Chee Kay Cheung, Vimal Derebail, Tim Doulton, Alastair Ferraro, Lindsy Forbess, Shouichi Fujimoto, Shunsuke Furuta, Ora Gewurz-Singer, Lorraine Harper, Toshiko Ito-Ihara, Nader Khalidi, Rainer Klocke, Curry Koening, Yoshinori Komagata, Carol Langford, Peter Lanyon, Raashid Luqmani, Carol McAlear, Larry W Moreland, Kim Mynard, Patrick Nachman, Christian Pagnoux, Chen Au Peh, Charles Pusey, Dwarakanathan Ranganathan, Rennie L Rhee, Robert Spiera, Antoine G Sreih, Vladamir Tesar, Giles Walters, Caroline Wroe, David Jayne, Peter A Merkel,
発行年月	2023/07
概要	OBJECTIVE:Following induction of remission with rituximab in anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) relapse rates are high, especially in patients with history of relapse. Relapses are associated with increased exposure to immunosuppressive medications, the accrual of damage and increased morbidity and mortality. The RITAZAREM trial compared the efficacy of repeat-dose rituximab to daily oral azathioprine for prevention of relapse in patients with relapsing AAV in whom remission was reinduced with rituximab.METHODS:RITAZAREM was an international randomised controlled, open-label, superiority trial that recruited 188 patients at the time of an AAV relapse from 29 centres in seven countries between April 2013 and November 2016. All patients received rituximab and glucocorticoids to reinduce remission. Patients achieving remission by 4 months were randomised to receive rituximab intravenously (1000 mg every 4 months, through month 20) (85 patients) or azathioprine (2 mg/kg/day, tapered after month 24) (85 patients) and followed for a minimum of 36 months. The primary outcome was time to disease relapse (either major or minor relapse).RESULTS:Rituximab was superior to azathioprine in preventing relapse: HR 0.41; 95% CI 0.27 to 0.61, p<0.001. 19/85 (22%) patients in the rituximab group and 31/85 (36%) in the azathioprine group experienced at least one serious adverse event during the treatment period. There were no differences in rates of hypogammaglobulinaemia or infection between groups.CONCLUSIONS:Following induction of remission with rituximab, fixed-interval, repeat-dose rituximab was superior to azathioprine for preventing disease relapse in patients with AAV with a prior history of relapse.TRIAL REGISTRATION NUMBER:NCT01697267; ClinicalTrials.gov identifier.
DOI	10.1136/ard-2022-223559
PMID	36958796