6/28/23, 12:25 AM CYCLOPS Pathway Feedback Search Clinical Topics Home Studies CYCLOPS CYCLOPS Disease Disease Disease Eosinophilic granulomatosis wit Granulomatosis with polyangiitis Micros Trial question What is the role of pulse cyclophosphamide regimen in patients with newly diagnosed generalized ANCA-associated vasculitis with renal involvement? Study design Multi-center Open label RCT Population Characteristics of study participants 41.0% female N = 149 59.0% male 149 patients (61 female, 88 male) Inclusion criteria: patients who had newly diagnosed generalized ANCA-associated vasculitis with renal involvement but not immediately life-threatening disease Key exclusion criteria: coexistence of other multisystem autoimmune disease, hepatitis B or C virus or HIV infection, serum creatinine level > 500 mol/L, previous cancer; pregnancy; or age < 18 or > 80 years Interventions N=76 pulse cyclophosphamide (intravenous 15 mg/kg every 2-3 weeks plus prednisolone) N=73 daily oral cyclophosphamide (2 mg/kg per day plus prednisolone) Primary outcome Remission at 9 months 88.1 % 88.1 87.7 https://web.pathway.md/studies/recYrc41EklXCHgbE 1/2 6/28/23, 12:25 AM CYCLOPS Pathway 66.1 % 44.0 % 22.0 % No significant difference 0.0 % Pulse cyclophosphamide Daily oral cyclophosphamide No significant difference in remission at 9 months (88.1% vs. 87.7%; RR 1, 95% CI -2.52 to 4.52) Secondary outcomes No significant difference in relapse (13 vs. 6; HR 2.01, 95% CI 0.77 to 5.3) Significant decrease in absolute cumulative cyclophosphamide dose (8.2 g vs. 15.9 g; HR 0.41, 95% CI 0.23 to 0.71) Safety outcomes Significant differences in leukopenia (26% vs. 45%, p = 0.016). Conclusion In patients who had newly diagnosed generalized ANCA-associated vasculitis with renal involvement but not immediately life-threatening disease, pulse cyclophosphamide was not superior to daily oral cyclophosphamide with respect to remission at 9 months. Reference de Groot K, Harper L, Jayne DR et al. Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):670-80. Open reference URL https://web.pathway.md/studies/recYrc41EklXCHgbE 2/2