Dimethyl fumarate and teriflunomide for multiple sclerosis in a real‐life setting: a French retrospective cohort study

Abstract

Background and purpose Dimethyl fumarate (DMF) and teriflunomide are approved oral disease‐modifying treatments for relapsing‐remitting multiple sclerosis (MS). Phase 3 trials established these agents to be effective and generally well tolerated, although comparative efficacy and discontinuation rates are still unknown. The aim of this study was to assess real‐world efficacy and discontinuation of DMF and teriflunomide in patients with relapsing‐remitting MS. Methods This retrospective observational cohort study was carried out in a French administrative region between March 2014 and July 2017. Patients who were followed by private or hospital neurologists were included. Efficacy and tolerance of the two treatments were assessed and compared by multivariate analysis, considering the duration of MS, annualized relapse rate and Expanded Disability Status Scale score at treatment initiation, treatment duration, type of prescriber and tobacco use. Results We identified 189 DMF‐ and 157 teriflunomide‐treated patients who had been treated for 22 ± 10 months. After correction for confounders, DMF more efficiently reduced the annualized relapse rate after 2 years than teriflunomide (0.06 vs. 0.21; P = 0.03). DMF‐treated patients had more clinical and biological adverse events, resulting in a higher rate of treatment discontinuation (28% vs. 12%, P = 0.03). Conclusion In this retrospective cohort study, DMF demonstrated significantly better efficacy over 2 years than teriflunomide, but tolerance to teriflunomide was better.

Effect of Teriflunomide and Dimethyl Fumarate on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective, Observational, Case-Control Pilot Study

“…Nevertheless, we examined clinical and MRI lesion activity measures in a post-hoc analysis between the two treatment groups. In line with several recent comparative effectiveness real-world studies between TFM and DMF [28,49,50], but contrary to others [51,52], we did not find any significant clinical (relapse rate and change in EDSS score) or MRI (new/enlarging T2 lesions, T1 pre- and post-contrast lesions and their volumes) differences between the two treatment groups in the current study. There were no unexpected safety signals for either treatment and the discontinuation rate was similar between the two treatment arms, as reported recently [53].…”

Untreated patients with multiple sclerosis: A study of French expert centers

“…In the present study, nearly 40% of patients with a single relapse and RR‐MS patients who were previously treated, stopped their DMT due to side effects, and stayed untreated thereafter. Although many DMTs are available, with minimal side effects for many patients, reducing the side effects of a first‐line DMT is still a major challenge for improving persistence with treatment [20,21]. This partially explains why 8% of RR‐MS patients had previously been treated with a median of two different DMTs, and were no longer being treated.…”

Real-world discontinuation rate of teriflunomide and dimethyl fumarate in multiple sclerosis

“…The lower risk of discontinuation because of treatment failure among dimethyl fumarate users suggests that this therapy was more effective, as shown by others. [9][10][11] One study comparing dimethyl fumarate to teriflunomide reported a significantly lower annualized relapse rate during a 2-year period. 9 In a time-to-event study, a lower risk of relapses after 38 months was found for dimethyl fumarate in comparison with teriflunomide.…”

“…6 Dimethyl fumarate and teriflunomide have not been compared directly, but real-world studies comparing both efficacy and discontinuation rates have been presented recently with mixed results. [7][8][9][10][11] Variables associated with discontinuation have rarely been evaluated in these studies.…”