A Retrospective Assessment of Real-World Discontinuation Rates in Patients with Multiple Sclerosis Treated with Delayed-Release Dimethyl Fumarate
Delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) is an oral agent approved for relapsing multiple sclerosis (MS) that has been shown to reduce relapse rates and brain lesions versus placebo in two phase III clinical trials. The most commonly reported adverse events (AEs) were flushing and gastrointestinal (GI) intolerance, and further information about the impact of these in the real-world setting is still needed.
Objectives: The main objective of this study was to examine discontinuation rates associated with DMF when used for the treatment of relapsing MS in a real-world, clinical practice setting.
Data were collected retrospectively from charts of adult patients with relapsing remitting MS, who were treated at a single large institution in Australia, and completed ≥6 months of continuous therapy, either with DMF or another MS medication administered following DMF discontinuation. The primary endpoint was overall discontinuation rate. Secondary endpoints included discontinuation rate due to AEs and incidence of AEs (such as GI events) necessitating a change in dose.
Results: A total of 100 patients initially prescribed DMF between 1 October 2013 - 1 June 2014 were included in the analysis. The mean age of the patients was 43 years and 80% were female. The overall discontinuation rate was 14%, with GI tolerability issues as the most common reason for discontinuation (10% overall discontinued due to GI tolerability issues). Dose changes due to AEs occurred in 15% of patients. None of the AEs reported were considered serious. One patient discontinued due to lack of efficacy.
Conclusions: This study demonstrates that DMF has an acceptable tolerability profile in the real-world setting that is similar to that demonstrated in clinical trials.