Rituximab and glatiramer acetate in secondary progressive multiple sclerosis: A randomized clinical trial.

Abstract

Treatment options for secondary progressive multiple sclerosis (SPMS) are limitedly investigated. We aimed to compare the efficacy of rituximab (RTX) and glatiramer acetate (GA) in SPMS patients. This open, randomized clinical trial was conducted on 84 SPMS patients, assigned to receive RTX or GA for 12months. In RTX group, patients received 1g intravenous RTX primarily and then every 6-months. In GA group, patients received 40mg of GA 3-times/week subcutaneously. We measured EDSS as the primary outcome and neuroimaging findings, relapse rate (RR), and side effects as the secondary outcomes. Seventy-three patients completed the study (37 and 36 in RTX and GA groups, respectively). The mean EDSS increased from 3.05±1.01 to 4.14±0.91 in RTX group (p<0.001) and from 3.22±1.20 to 4.60±0.67 in GA group (p<0.001). No statistically significant difference was observed in EDSS between two groups (F(1, 67)=3.377; p=0.071). The number of active lesions in brain and cervical spine decreased with no difference between groups (p>0.05). Also, RR decreased in both groups without significant difference between them (F(1, 67)=0.390; p=0.534). Non-serious complications were observed in both groups. Neither RTX nor GA affects EDSS in SPMS patients. They are equally effective in the relapse control of these patients.