Efficacy
DISEASE, REGRESSION, MINOR, REMISSION
Over the combined maintenance and follow-up phases, rituximab was superior to azathioprine for the prevention of major or minor disease relapse: HR 0.41, 95% CI 0.27 to 0.61, p<0.001 (Probability of relapse-free survival: rituximab compared with azathioprine. Black arrows represent 1000 mg dose of rituximab. Dashed vertical line indicates end of maintenance treatment period and start of the follow-up period per protocol. Shaded areas represent 95% CIs.Thirty-eight of 85 (45%) patients in the rituximab group experienced 52 relapses, 11 major and 41 minor. Sixty of 85 (71%) patients in the azathioprine group experienced 89 relapses, 28 major and 61 minor. The overall HR for major relapse was 0.36, 95% CI 0.18 to 0.73, p=0.004. During the maintenance phase, 13/85 (15%) in the rituximab group relapsed compared with 32/85 (38%) in the azathioprine group. At month 24, the relapse-free survival rate was 0.85, 95% CI 0.78 to 0.93, for the rituximab compared with 0.61, 95% CI 0.51 to 0.73, for the azathioprine groups. During the follow-up phase, there were 33 relapses in 25 from the rituximab compared with 49 relapses in 28 in the azathioprine groups. Five patients in the rituximab group experienced a major relapse during the follow-up period compared with 11 in the azathioprine group. At month 48, the rate for continued remission was 0.50, 95% CI 0.40 to 0.63, for the rituximab and 0.22, 95% CI 0.14 to 0.35, for the azathioprine groups.In a multiple regression model, neither the glucocorticoid induction regimen (high or low dose) nor ANCA subtype (PR3-ANCA or MPO-ANCA) influenced relapse risk: HR 1.29, 95% CI 0.82 to 2.04, p=0.277 and HR 1.23, 95% CI 0.76 to 1.98, p=0.402, respectively (
Multivariate model of clinical predictors for relapse in the RITAZAREM trial. Induction regimen refers to glucocorticoid dose. 1A—1 mg/kg/day starting dose (maximum 60 mg daily); 1B—0.5 mg/kg/day starting dose (maximum 30 mg daily). PR3, proteinase 3; MPO, myeloperoxidase. The estimates are from a multiple regression model that simultaneously adjusts for the treatment and all covariates.