SAFETY AND EFFICACY OF RITUXIMAB FOR SYSTEMIC SCLEROSIS: A DOUBLE-BLIND, PARALLEL-GROUP COMPARISON, INVESTIGATORS INITIATED CONFIRMATORY RANDOMIZED CLINICAL TRIAL (DESIRES STUDY)
Authors: S. Ebata et al.
Rituximab for systemic sclerosis was evaluated in a multicenter, double-blind, placebo-controlled, parallel-group comparison, investigator-initiated clinical trial. Patients were randomized 1:1 to rituximab (375 mg/m2) or placebo once a week for 4 weeks. The primary endpoint was the change in the modified Rodnan skin score after 24 weeks. The main secondary endpoint was the change in %forced vital capacity (%FVC) at 24 weeks.
54 patients received rituximab or placebo. Twenty-four weeks after the start of the intervention, the modified Rodnan skin score improved in the rituximab group compared to placebo (6.30 decrease in the rituximab group vs. 2.14 increase in the placebo group; P < 0.0001). The %FVC of 48 patients with interstitial lung disease significantly improved in the rituximab group compared to the placebo group at 24 weeks (0.09% improvement with rituximab vs. 2.87% deterioration with placebo; difference 2.96%; P = 0.04). Adverse events were comparable between groups.
This study is the first of several larger RCTs to validate the efficacy and safety of rituximab in SSc. Its results along with the promising data from other open-label RCTs and case-control studies justify the use of rituximab in clinical practice, given the paucity of safe and effective therapeutic alternatives.