Abstract: SA-OR028
A Randomized Controlled Trial of Rituximab (RTX) vs. Azathioprine (AZA) After Induction of Remission with RTX for Patients with ANCA-Associated Vasculitis (AAV) and Relapsing Disease
Session Information
- ANCA It Is
November 09, 2019 | Location: 207, Walter E. Washington Convention Center
Abstract Time: 05:54 PM - 06:06 PM
Category: Glomerular Diseases
- 1203 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Smith, Rona M., University of Cambridge, Cambridge, United Kingdom
- Jayne, David R.W., University of Cambridge, Cambridge, United Kingdom
- Merkel, Peter A., University of Pennsylvania, Philadelphia, Pennsylvania, United States
Group or Team Name
- RITAZAREM trial investigators
Background
RTX is an effective remission induction therapy in AAV. However, the effect of RTX is not sustained, and relapse rates are high, especially in patients with a history of relapse. The RITAZAREM trial is an international, open label, randomized, controlled trial of patients with AAV with relapsing disease comparing the efficacy, after remission induction with RTX, of repeat dose RTX or AZA as relapse prevention strategies.
Methods
Patients with relapsing AAV received induction therapy with RTX and glucocorticoids (GC). If remission was achieved by month 4, patients were randomized 1:1 to receive RTX (1000mg every 4 months for 5 doses) or AZA as maintenance therapy. Patients were followed for a minimum of 36 months, with a primary outcome of time to disease relapse.
Results
190 patients were enrolled and 170 randomized at month 4 (85 to RTX; 85 to AZA). Data are complete on all patients up to at least month 24. Median age was 59 years (range 19-89), with a prior disease duration of 5.3 years (0.4-38.5). 123/170 (72%) of patients were historically positive for anti-PR3 ANCA; 104 (61%) were enrolled after a major relapse, and 48 (28%) received a higher dose GC induction regimen. 114 (67%) patients had prior renal involvement. RTX was superior to AZA in preventing relapse with a preliminary overall HR estimate of 0.36 (95% CI 0.23-0.57, p<0.001) and a during-treatment HR estimate of 0.30 (95% CI 0.15-0.60, p<0.001) (Figure 1). By 24 months after entry, 20 months after randomization, 11/85 (13%) patients in the RTX group had experienced a relapse compared to 32/85 (38%) in the AZA group. 9 (22%) patients in the RTX group and 31 (36%) patients in the AZA group experienced at least one severe adverse event.
Conclusion
RTX was superior to AZA in the prevention of relapse in patients with AAV with a prior history of relapse following induction of remission with RTX
Funding
- Commercial Support – Genentech/Roche