Abstract
Objectives To explore the safety and efficacy profile of teriflunomide in progressive multiple sclerosis. Methods We conducted a single-center retrospective observational analysis of a progressive multiple sclerosis population, assessing safety and efficacy in patients treated at least one year with teriflunomide or glatiramer acetate. Sustained progression of expanded disability status scale and sustained worsening of timed 25-foot walk were compared using a Cox proportional hazards model. Results Teriflunomide group (n = 29) mean characteristics: age = 58 years (SD ± 7.6), disease duration = 16.7 years (SD ± 9.5), expanded disability status score = 5.9 (SD ± 1.3), and follow − up = 32.4 months (SD ± 13.6). Glatiramer acetate group (n = 30) mean characteristics: age = 52.4 years (SD ± 11.3), disease duration = 15.1 years (SD ± 10.4), expanded disability status score = 5.7 (SD ± 1.6), and follow − up = 46.9 months (SD ± 43.9). Both treatments were well tolerated without serious side effects. After adjustment for age, sex, and baseline expanded disability status score, sustained expanded disability status score progression did not differ between groups (hazard ratio = 1.17; 95% confidence interval: 0.45, 3.08; p = 0.75). Sustained timed 25-foot walk worsening after adjustment also did not differ (hazard ratio = 0.56; 95% confidence interval: 0.2, 1.53; p = 0.26). Conclusion In an advanced progressive multiple sclerosis population, no substantial differences in tolerability, safety, sustained EDSS progression, or sustained T25FW worsening over time were observed between glatiramer acetate and teriflunomide-treated groups. The small sample precluded definitive determination.
Highlights
There are many approved agents for treatment of relapsingremitting multiple sclerosis (MS), but few options exist for patients with progressive forms of MS
Many drugs including interferon beta-1a subcutaneous [5], interferon beta-1a intramuscular [6], glatiramer acetate [7], fingolimod [8], and natalizumab [9] have failed in randomized controlled trials in primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS)
After screening for inclusion/exclusion criteria, fifty-nine patients were included in the study, twenty-nine patients in the teriflunomide group, and thirty patients in the glatiramer acetate group (Figure 1)
Summary
There are many approved agents for treatment of relapsingremitting multiple sclerosis (MS), but few options exist for patients with progressive forms of MS. A phase three trial of ocrelizumab in a primary progressive population achieved a 24% reduction in patients experiencing 12-week confirmed disability progression compared to placebo. The safety profile of ocrelizumab in trial was ostensibly good but requires further definition over time [2, 3]. Siponimod demonstrated efficacy in a phase three trial in secondary progressive multiple sclerosis (SPMS) patients, resulting in a 21% reduction in patients with 12-week confirmed disability progression [4] and will require further characterization of safety profile over time. Many drugs including interferon beta-1a subcutaneous [5], interferon beta-1a intramuscular [6], glatiramer acetate [7], fingolimod [8], and natalizumab [9] have failed in randomized controlled trials in primary progressive multiple sclerosis (PPMS) or SPMS
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