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Rituximab versus azathioprine for maintenance of remission for patients with ANCA-associated vasculitis and relapsing disease: an international randomised controlled trial. 2023
Rona M Smith, and
Rachel B Jones, and
Ulrich Specks, and
Simon Bond, and
Marianna Nodale, and
Reem Al-Jayyousi, and
Jacqueline Andrews, and
Annette Bruchfeld, and
Brian Camilleri, and
Simon Carette, and
Chee Kay Cheung, and
Vimal Derebail, and
Tim Doulton, and
Alastair Ferraro, and
Lindsy Forbess, and
Shouichi Fujimoto, and
Shunsuke Furuta, and
Ora Gewurz-Singer, and
Lorraine Harper, and
Toshiko Ito-Ihara, and
Nader Khalidi, and
Rainer Klocke, and
Curry Koening, and
Yoshinori Komagata, and
Carol Langford, and
Peter Lanyon, and
Raashid Luqmani, and
Carol McAlear, and
Larry W Moreland, and
Kim Mynard, and
Patrick Nachman, and
Christian Pagnoux, and
Chen Au Peh, and
Charles Pusey, and
Dwarakanathan Ranganathan, and
Rennie L Rhee, and
Robert Spiera, and
Antoine G Sreih, and
Vladamir Tesar, and
Giles Walters, and
Caroline Wroe, and
David Jayne, and
Peter A Merkel, and
Medicine, University of Cambridge, Cambridge, UK rms50@cam.ac.uk.
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. 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). 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. 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. NCT01697267; ClinicalTrials.gov identifier.
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