Valérie Bénard1, Cynthia Farhat2, Melissa Zarandi-Nowroozi2, Madeleine Durand3, Pierre Charles4, Xavier Puéchal4, Loic Guillevin4, Christian Pagnoux5, Jean-Paul Makhzoum1. 1. Canadian Network for Research on Vasculitides, Hôpital Sacré-Coeur de Montréal, and University of Montreal, Montreal, Quebec, Canada. 2. University of Montreal, Montreal, Quebec, Canada. 3. Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada. 4. National Referral Center for Rare Systemic Autoimmune Diseases, Université de Paris, and Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France. 5. Canadian Network for Research on Vasculitides, Mount Sinai Hospital, and University of Toronto, Toronto, Ontario, Canada.
Abstract
OBJECTIVE: The objective of this study was to compare the efficacy and safety of two rituximab (RTX) regimens for the induction of remission in severe antineutrophil cytoplasm antibody-associated vasculitis (AAV): the four-dose (375 mg/m2 intravenously weekly) versus the two-dose (1000 mg intravenously biweekly) regimen. METHODS: A systematic review was performed to identify studies using the four- and/or two-dose RTX regimens for induction of remission in severe AAV. Disease status 6 months after RTX infusion was required for inclusion. Patients were excluded if they received concomitant cyclophosphamide or plasma exchange. The primary end point was the proportion of patients in complete remission at 6 months. The pooled estimate was obtained by using meta-analysis methods for proportions with random effects. Secondary end points included antineutrophil cytoplasm antibody status, number of patients with B-cell depletion, mean prednisone dose, infections, and death. RESULTS: A total of 27 studies and 506 patients were included for analysis: 361 patients received the four-dose regimen, and 145 patients received the two-dose regimen. Most patients had relapsing disease at inclusion (83% and 92% of patients, respectively). There was no significant difference between the four- and two-dose regimens, with a complete remission achieved in 85% (95% confidence interval [CI]: 70-96) and 91% (95% CI: 79-99) of patients, respectively. At 6 months, both regimens were associated with a similar mean daily prednisone dose (8.1 mg), infections (12% in both), and death (1% vs 0%, respectively). CONCLUSION: No difference was found in terms of efficacy or safety between the four- and two-dose RTX regimens for induction of remission in severe AAV.
OBJECTIVE: The objective of this study was to compare the efficacy and safety of two rituximab (RTX) regimens for the induction of remission in severe antineutrophil cytoplasm antibody-associated vasculitis (AAV): the four-dose (375 mg/m2 intravenously weekly) versus the two-dose (1000 mg intravenously biweekly) regimen. METHODS: A systematic review was performed to identify studies using the four- and/or two-dose RTX regimens for induction of remission in severe AAV. Disease status 6 months after RTX infusion was required for inclusion. Patients were excluded if they received concomitant cyclophosphamide or plasma exchange. The primary end point was the proportion of patients in complete remission at 6 months. The pooled estimate was obtained by using meta-analysis methods for proportions with random effects. Secondary end points included antineutrophil cytoplasm antibody status, number of patients with B-cell depletion, mean prednisone dose, infections, and death. RESULTS: A total of 27 studies and 506 patients were included for analysis: 361 patients received the four-dose regimen, and 145 patients received the two-dose regimen. Most patients had relapsing disease at inclusion (83% and 92% of patients, respectively). There was no significant difference between the four- and two-dose regimens, with a complete remission achieved in 85% (95% confidence interval [CI]: 70-96) and 91% (95% CI: 79-99) of patients, respectively. At 6 months, both regimens were associated with a similar mean daily prednisone dose (8.1 mg), infections (12% in both), and death (1% vs 0%, respectively). CONCLUSION: No difference was found in terms of efficacy or safety between the four- and two-dose RTX regimens for induction of remission in severe AAV.