Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.
Cheung, Chee Kay
Luqmani, Raashid Ahmed
McAlear, Carole A
Moreland, Larry W
Sreih, Antoine G
Weisman, Michael H
Merkel, Peter A
Annals of the rheumatic diseases
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Smith, R., Jones, R. B., Specks, U., Bond, S., Nodale, M., Aljayyousi, R., Andrews, J., et al. (2020). Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.. Annals of the rheumatic diseases, 79 (9), 1243-1249. https://doi.org/10.1136/annrheumdis-2019-216863
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: Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4 x 375 mg/m2) 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 randomized to receive one of two regimens to prevent relapse. Results: 188 patients were studied: 95/188 (51%) male, 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 ANCA-associated vasculitis treated with rituximab in conjunction with glucocorticoids, demonstrated a high level of efficacy for the re-induction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.
RITAZAREM coinvestigators, RITAZAREM co-investigators, Humans, Recurrence, Antirheumatic Agents, Glucocorticoids, Treatment Outcome, Drug Therapy, Combination, Prospective Studies, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Young Adult, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Induction Chemotherapy, Rituximab
RITAZAREM is funded by grants from Versus Arthritis (formerly Arthritis Research UK) (Grant number 18706) and Roche/Genentech (MA28150). The Vasculitis Clinical Research Consortium (VCRC) (U54 AR057319 and U01 AR5187404) is part of the United States National Institutes of Health Rare Diseases Clinical Research Network (RDCRN), an initiative of the Office of Rare Diseases Research (ORDR), National Center for Advancing Translational Science (NCATS). The VCRC is funded through collaboration between NCATS, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and has received funding from the National Center for Research Resources (U54 RR019497). The Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan. This research was also supported by the National Institute for Health Research (NIHR), Cambridge Biomedical Research Centre, and the Cambridge Clinical Trials Unit (CCTU).
Arthritis Research Uk (19706)
External DOI: https://doi.org/10.1136/annrheumdis-2019-216863
This record's URL: https://www.repository.cam.ac.uk/handle/1810/305093
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