Compliance with treatment per protocol
81/85 (95%) patients in the rituximab group were compliant and 78/85 (92%) in the azathioprine group. During the follow-up phase, 10/85 (12%) patients in the rituximab and 15/85 (18%) patient in the azathioprine groups continued immunosuppression. When the 11 patients non-compliant during the treatment period with the protocol-defined immunosuppressive therapy were excluded in the analysis, the HR for relapse was 0.38, 95% CI 0.25 to 0.58, p<0.001. When the 25 patients non-complaint during either the treatment or the follow-up phase were excluded in the analysis, the HR for relapse was 0.36, 95% CI 0.23 to 0.57, p<0.001.The median cumulative prednisolone dose during the maintenance phase was identical in both groups (median 2100 mg, ranges 0–5700 mg in rituximab and 0–9000 mg in the azathioprine groups), deviations from the protocol were common, 44 (52%) in the rituximab and 57 (67%) in the azathioprine groups reported at least one deviation during the trial. At month 24, by which time the protocol-required cessation of glucocorticoids, 22/77 (29%) in the rituximab and 35/76 (46%) in the azathioprine groups were still receiving glucocorticoids, mean daily doses=2.28 mg (SD=5.45) for the rituximab and 2.8 mg (SD 5.5) for the azathioprine groups.