Real-World Experience with Diroximel Fumarate in Patients with Multiple Sclerosis: A Prospective Multicenter Study

Area of Science:

• Neurology
• Immunology
• Pharmacology

Background:

• Diroximel fumarate (DRF) is suggested to be safer than dimethyl fumarate (DMF) for multiple sclerosis (MS).
• Limited real-world data exists on the efficacy of DRF in MS treatment.
• This study addresses the safety, tolerability, and efficacy of DRF in a real-world setting.

Purpose of the Study:

• To evaluate the safety and tolerability of diroximel fumarate (DRF) in a real-world multiple sclerosis (MS) patient cohort.
• To assess the efficacy of DRF in managing clinical and radiological disease activity in MS.
• To gather data from a Spanish national registry of patients initiating DRF therapy.

Main Methods:

• A multicenter, prospective observational study design was employed.
• Data collected from 195 MS patients initiating DRF treatment across 26 neurological departments.
• Monitored demographic and clinical characteristics, safety outcomes (adverse events, discontinuation reasons, lymphocyte counts), and efficacy outcomes (radiological and clinical activity).

Main Results:

• 195 MS patients (79.5% female, mean age 42.17) were included, with a mean DRF treatment duration of 6.3 months.
• 70.3% reported no adverse events; gastrointestinal issues and flushing were most common.
• 84.6% continued DRF; tolerability was the main discontinuation reason. Low relapse rates, stable/improved EDSS scores, and minimal radiological activity were observed.

Conclusions:

• Real-world data confirms the safety and tolerability of diroximel fumarate (DRF) in multiple sclerosis (MS) management.
• Preliminary evidence suggests DRF demonstrates efficacy in controlling disease activity.
• This study provides valuable insights into DRF's practical application for MS patients.