Comparison of the efficacy of rituximab and glatiramer acetate in patients with active secondary progressive multiple sclerosis: A randomized clinical trial

سال انتشار: 1398
محل انتشار: شانزدهمین کنگره بین المللی ام اس
کد COI اختصاصی: MSC16_033
زبان مقاله: انگلیسی
تعداد مشاهده: 444

نویسندگان

Isfahan neurosciences research center, Isfahan, Iran

چکیده

Introduction: Secondary progressive multiple sclerosis (SPMS) is a debilitating subtype of MS with cumulative deterioration of neurological impairment. Treatment options for SPMS are limitedly investigated. We aimed to compare the efficacy of rituximab (RTX) and Glatiramer acetate (GA) in SPMS patients.Methods: We conducted an open, randomized clinical trial during December 2017 to March 2019, in Isfahan, Iran. We approached 159 patients, 84 entered the study and 73 completed the study. All patients had expanded disability status scale (EDSS) ≤5 (mean:3.16±1.17). They were randomized into two groups. In RTX group, 37 patients received 1 g intravenous rituximab 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, side-effects, neuroimaging findings, and relapse rate (RR) as the secondary outcomes, after 12-months of intervention.Results: 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). EDSS scores were higher in GA group compared to RTX group at the end of study (F(1,70)=4.862; p=0.031). The number of active lesions in both brain and cervical spine decreased following therapy with no difference between groups (p> 0.05). Also, RR decreased in both groups following therapy (p< 0.001) with no difference between groups (F(1,70)=0.381; p=0.539). We observed non-serious complications in both groups without any differences (8 in RTX and 7 in GA group, p=0.818).Conclusion: Rituximab is superior to GA regarding deceleration of disability progression and could be a treatment option for SPMS patients.

کلیدواژه ها

Secondary progressive multiple sclerosis; rituximab; glatiramer acetate; randomized clinical trial; efficacy; comparative study

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