Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis
Rona Smith, Rachel Jones, Ulrich Specks, Simon Bond, Marianna Nodale, Reem Al-Jayyousi, Jacqueline Andrews, Annette Bruchfeld, Brian Camilleri, Simon Carette, Chee Kay Cheung, Vimal K. Derebail, Tim Doulton, Lindsy Forbess, Shouichi Fujimoto, Shunsuke Furuta, Ora Gewurz‐Singer, Lorraine Harper, Toshiko Ito‐Ihara, Nader Khalidi, Rainer Klocke, Curry L. Koening, Yoshinori Komagata, Carol A. Langford, Peter Lanyon, Raashid Luqmani, Hirofumi Makino, C. McAlear, Paul A. Monach, Larry W. Moreland, Kim Mynard, Patrick H. Nachman, Christian Pagnoux, Fiona Pearce, Chen Au Peh, Charles D. Pusey, Dwarakanathan Ranganathan, Rennie L. Rhee, Robert Spiera, Antoine G. Sreih, Vladimı́r Tesař, Giles Walters, Michael H. Weisman, Caroline Wroe, Peter A. Merkel, David Jayne
Abstract
OBJECTIVES: Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial. METHODS: ) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse. RESULTS: 188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections. CONCLUSIONS: This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.