New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis

Area of Science:

• Pharmacology and Therapeutics
• Neuroimmunology
• Health Economics

Background:

• Multiple Sclerosis (MS) treatments historically relied on interferon injectables and glatiramer acetate.
• The early 2010s saw an expansion of disease-modifying therapies for MS, broadening treatment choices.
• Relapsing-remitting MS (RRMS) is a primary focus for these new therapeutic agents.

Purpose of the Study:

• To critically evaluate the safety and efficacy of US FDA-approved disease-modifying agents for MS from 2010 onwards.
• To provide cost and pharmacoeconomic data for newly available MS treatments.
• To assess the evolving landscape of MS pharmacotherapy.

Main Methods:

• Systematic literature review of peer-reviewed clinical trials and pharmacoeconomic studies.
• Searches conducted on MEDLINE (2000-2014) using specific MS drug and pharmacoeconomic terms.
• Inclusion of data from clinicaltrials.gov and FDA.gov for unpublished or ongoing studies.

Main Results:

• Five new agents and one new dosage formulation for RRMS were FDA-approved post-2010.
• New injectables (peginterferon beta-1a, high-dose glatiramer acetate) and oral agents (fingolimod, teriflunomide, dimethyl fumarate) demonstrated significant relapse rate reductions.
• Alemtuzumab showed substantial efficacy in both treatment-naive and previously treated patients; however, treatment-emergent adverse effects were common across all new therapies, and costs remain high (approx. $6000/month).

Conclusions:

• The expanded range of MS treatments provides patients and providers with greater management flexibility.
• Treatment decisions are influenced by patient preference, efficacy, and risk, with the relative place in therapy still evolving.
• Despite increased treatment options, the high cost of managing MS persists.