Clinical evaluation of dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis: efficacy, safety, patient experience and adherence.

Abstract

Dimethyl fumarate (DMF) is an oral disease-modifying therapy approved for management of relapsing-remitting multiple sclerosis patients. Results from phase 3 clinical trials (DEFINE, CONFIRM) and follow-up study (ENDORSE) have provided good evidence for its efficacy and safety profile. Patient-reported outcomes (PROs) assessment revealed stabilization or boost in health-related quality of life and work productivity of patients treated with DMF compared to placebo reflecting a higher patient satisfaction to therapy. Being an oral agent with relatively favorable risk versus benefit profile DMF is commonly prescribed first-line agent. However, literature suggests that intolerance to side effects, especially gastrointestinal adverse effects and flushing is one of the major causes to compromised therapeutic compliance. An increase in the real-world incidence of progressive multifocal leukoencephalopathy and liver abnormality cases is also concerning. Several prevention and mitigation strategies like patient counseling, dose up-titration, pretreatment with aspirin, use of symptomatic therapy and frequent blood monitoring have demonstrated to be effective in tackling these adverse effects and promoting adherence to DMF. In this article, we review the efficacy, safety, PROs and patient adhere data, along with various measures to manage adverse events and promote compliance.