gms | German Medical Science

Introduction: In ANCA-associated vasculitis (AAV), the use of rituximab (RTX) according to the RAVE trial [1] or RTX in combination with cyclophosphamide (CYC) according to the RITUXVAS trial [2] showed noninferiority to CYC for the induction of remission. However, there is a lack of comparative real-world data between both therapy regimens. This study aimed to compare the effectiveness of RTX with combined RTX/CYC for remission induction in AAV.

Methods: In this comparative effectiveness retrospective monocentric study, data from 166 patients with AAV (granulomatosis with polyangiitis [GPA] n=97; microscopic polyangiitis [MPA], n=69) were analyzed. Patients were treated first-line with RTX, RTX/CYC, or CYC between January 2012 and November 2022. The primary outcome was the relapse rate at 24 months. Clinical data (BVAS, therapy) and serologic markers (creatinine, protein excretion, CRP, immunoglobulin levels) were assessed at baseline and every 6 months up to 24 months.

Results: Of the 166 patients, 81 received first-line RTX (RAVE), 23 RTX/CYC (RITUXVAS), and 62 CYC according to CYCLOPS [3]. At baseline, there was no difference between RAVE and RITUXVAS treatment groups with respect to disease activity. In AAV, treatment according to RAVE and RITUXVAS was not inferior to treatment according to CYCLOPS for the induction of remission (figure 1 [Fig. 1]). Moreover, RTX was not inferior to RTX/CYC (HR 0.61, P=0.1356, figure 1 [Fig. 1]). Interestingly, subgroup analysis showed RAVE was slightly superior to RITUXVAS in GPA (HR: 0.48, P=0.0408, figure 1 [Fig. 1]). RTX and RTX/CYC were superior to CYCLOPS in prednisolone dose reduction at 12 months (AAV: P=0.0074; GPA: P=0.0048, figure 2 [Fig. 2]).

Conclusion: In AAV, RTX and the combination of RTX/CYC were not inferior to CYC for remission induction. Both RTX-based therapies lead to a faster prednisolone reduction compared to CYC alone. The combination of RTX and CYC was not superior to RTX alone.