Oral Agents for Relapsing–Remitting Multiple Sclerosis

The year 2010 marks the beginning of a new era in MS therapy, with the publication of three reports of successful phase III clinical trials of two oral agents.

In three manufacturer-sponsored, multinational, double-blind, placebo-controlled, randomized clinical trials, researchers tested two oral drugs that work by novel mechanisms to treat multiple sclerosis (MS): fingolimod in the FREEDOMS and TRANSFORMS studies and cladribine in the CLARITY study. The studies had similar inclusion and exclusion criteria: Participants had relapsing–remitting MS (RRMS) according to the McDonald criteria (revised criteria for FREEDOMS and TRANSFORMS), at least one relapse in the previous year (or two in the previous 2 years for FREEDOMS and TRANSFORMS), and Expanded Disability Status Scale scores of 0–5.5.

Oral fingolimod is a sphingosine-1-phosphate–receptor modulator that restricts lymphocytes to lymph nodes, red…

Reviewing Author

Hillel Panitch, MD