6/29/23, 12:43 AM RAVE Pathway Feedback Search Clinical Topics Home Studies RAVE RAVE Disease Disease Granulomatosis with polyangiitis Microscopic polyangiitis Trial question Is rituximab noninferior to cyclophosphamide in patients with severe ANCA-associated vasculitis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 50.0% female N = 197 50.0% male 197 patients (100 female, 100 male) Inclusion criteria: ANCA-positive patients with either Wegener's granulomatosis or microscopic polyangiitis Key exclusion criteria: Churg-Strauss syndrome or anti-GBM disease, alveolar hemorrhage severe enough to require mechanical ventilation, renal failure, active systemic infection, osteomyelitis, septic arthritis, or pneumonia complicated by empyema, or severe liver disease Interventions N=99 rituximab (intravenous 375 mg per square meter of body-surface area per week for 4 weeks plus corticosteroid regimen) N=98 cyclophosphamide (2 mg/kg of body weight per day, adjusted for renal insufficiency plus corticosteroid regimen) https://web.pathway.md/studies/recFNQpCVDftG6N4F 1/2 6/29/23, 12:43 AM RAVE Pathway Primary outcome Remission of disease without use of prednisone at 6 months 64.0 % 64 53 48.0 % 32.0 % Difference not exceeding nonferiority margin 16.0 % 0.0 % Rituximab Cyclophosphamide Difference not exceeding nonferiority margin in remission of disease without the use of prednisone at 6 months (64% vs. 53%; ARD 11, 95% CI 4.47 to 17.53) Secondary outcomes Significant increase in remission induction of relapsing disease (67% vs. 42%; RR 1.6, 95% CI 0.38 to 2.82) Significant increase in the rate of ANCA response, by 6 months (47% vs. 24%; RR 1.96, 95% CI 0.63 to 3.29) Safety outcomes No significant difference in rates of total or serious adverse events. Conclusion In ANCA-positive patients with either Wegener's granulomatosis or microscopic polyangiitis, rituximab was noninferior to cyclophosphamide with respect to remission of disease without the use of prednisone at 6 months. Reference Stone JH, Merkel PA, Spiera R et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. Open reference URL https://web.pathway.md/studies/recFNQpCVDftG6N4F 2/2