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

BACKGROUND

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.

METHOD

This open, randomized clinical trial was conducted on 84 SPMS patients, assigned to receive RTX or GA for 12 months. In RTX group, patients received 1 g intravenous RTX primarily and then every 6-months. In GA group, patients received 40 mg 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.

RESULTS

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.

CONCLUSION

Neither RTX nor GA affects EDSS in SPMS patients. They are equally effective in the relapse control of these patients.