SwissTecLive: effectiveness and safety of dimethyl fumarate in the treatment of RRMS in the Swiss clinical practice setting

Chiara Zecca,Adam Czaplinski,Christophe Henny,Liliane Petrini,Andreas Beeler,Claudio Gobbi

doi:10.1016/j.heliyon.2020.e05819

Abstract

BackgroundDelayed-released dimethyl fumarate (DMF) is an oral disease-modifying therapy (DMT) approved for treating patients with multiple sclerosis (MS). This post-marketing study aimed at collecting real-world data on the safety, effectiveness, and tolerability of DMF in patients with relapsing remitting multiple sclerosis (RRMS). Methods1-year post-marketing survey of patients prescribed DMF followed-up quarterly in hospital setting and private neurological practices in Switzerland from January 2015 to January 2018. Data on relapses, Expanded disability status scale (EDSS) score change, safety, tolerability, treatment adherence as judged by the treating neurologist and satisfaction were collected. Patients could refer to a patient support program. ResultsOf the 158 patients, 67 (42.4%) were treatment naïve, 91 (57.6%) switched from a prior MS DMT to DMF, 131 (82.9%) were treatment adherent, 108 (68.4%) used the support program, and 45 (28.5%) discontinued the therapy. Insufficient tolerability and insufficient effectiveness were the main reasons for discontinuation. 134 (84.8%) patients remained relapse free, 97 (61.4%) had stable or decreased EDSS score after 12 months. 74 (46.8%) patients reported adverse events; of these, 28 (17.7%) discontinued DMF treatment. Physicians and patients rated treatment satisfaction similarly (median score 8.0 of 10). ConclusionsThe results obtained from this real-world observation are consistent with the efficacy and safety findings reported in pivotal and larger observational trials evaluating DMF treatment. Most side effects were experienced early after therapy initiation reflecting the timing of therapy discontinuation.

Highlights

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (Reich et al, 2018)
This was a 1-year, post-marketing survey of dimethyl fumarate (DMF) use prescribed to relapsing remitting multiple sclerosis (RRMS) patients in Switzerland initiated by Biogen Switzerland AG conducted from January 2015 until January 2018
Specialized private neurological practices and hospital ambulatories in Switzerland experienced with DMF were contacted 6 months after launch

Summary

Introduction

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (Reich et al, 2018). One of four oral treatments for relapsing-remitting multiple sclerosis (RRMS) available on the Swiss market is delayed-released dimethyl fumarate (DMF). After launch in Switzerland in 2014, a post-marketing survey collected data on real-world effectiveness and tolerability of DMF in Swiss RRMS patients who were either treatment naïve or switching from any first DMT to DMF and who were followed-up according to routine clinical practice. Delayed-released dimethyl fumarate (DMF) is an oral disease-modifying therapy (DMT) approved for treating patients with multiple sclerosis (MS). This post-marketing study aimed at collecting real-world data on the safety, effectiveness, and tolerability of DMF in patients with relapsing remitting multiple sclerosis (RRMS). Most side effects were experienced early after therapy initiation reflecting the timing of therapy discontinuation

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