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Randomized Controlled Trial
. 2021 Feb;143(2):178-187.
doi: 10.1111/ane.13344. Epub 2020 Oct 27.

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

Masoumeh Cheshmavar  1   2 , Omid Mirmosayyeb  1   2 , Negin Badihian  1   3 , Shervin Badihian  4 , Vahid Shaygannejad  1   2
Affiliations
Randomized Controlled Trial

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

Masoumeh Cheshmavar et al. Acta Neurol Scand. 2021 Feb.

Abstract

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.

Keywords: clinical trial; glatiramer acetate; multiple sclerosis; rituximab; treatment.

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References

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