Oral disease-modifying therapies for relapsing-remitting multiple sclerosis

Area of Science:

• Neurology
• Pharmacology
• Immunology

Background:

• Parenteral disease-modifying therapies (DMTs) like interferon beta-1a, interferon beta-1b, and glatiramer acetate have limitations for treating relapsing-remitting multiple sclerosis (RRMS).
• The development of oral DMTs represents a significant advancement in RRMS management.

Purpose of the Study:

• To review the efficacy and safety of three Food and Drug Administration-approved oral agents for RRMS treatment.
• To compare the new oral DMTs with established parenteral therapies.

Main Methods:

• Review of clinical trial data for fingolimod, teriflunomide, and dimethyl fumarate.
• Analysis of efficacy endpoints including annualized relapse rate and neuroradiological measures.
• Evaluation of safety profiles and adverse event data.

Main Results:

• All three oral DMTs demonstrated superiority to placebo in reducing annualized relapse rate and improving neuroradiological efficacy.
• Teriflunomide showed a reduction in disability progression at higher doses, though this was not consistent for fingolimod or dimethyl fumarate.
• Each oral DMT has a distinct safety profile, with fingolimod requiring cardiac monitoring and teriflunomide associated with hepatotoxicity and teratogenicity.

Conclusions:

• The approval of fingolimod, teriflunomide, and dimethyl fumarate has expanded therapeutic options for RRMS, offering administration advantages over parenteral treatments.
• Dimethyl fumarate appears to have the most favorable safety profile among the three oral agents.
• Postmarketing surveillance is crucial to fully ascertain the long-term safety of these oral DMTs in RRMS patients.