Oral fingolimod vs placebo for relapsing multiple sclerosis

January 01, 0001

Oral fingolimod vs placebo for relapsing multiple sclerosis

These investigators from multiple countries compared oral fingolimod at a dose of 0.5 mg or 1.25 mg daily with placebo in a 24-month, double-blind, randomized study. They enrolled patients who had relapsing-remitting multiple sclerosis, were 18 to 55 years of age, had a score of 0 to 5.5 on the Expanded Disability Status Scale (which ranges from 0 to 10, with higher scores indicating greater disability), and had had one or more relapses in the previous year or two or more in the previous 2 years.

They found: "total of 1033 of the 1272 patients (81.2%) completed the study. The annualized relapse rate was 0.18 with 0.5 mg of fingolimod, 0.16 with 1.25 mg of fingolimod, and 0.40 with placebo (both statistically significant). Fingolimod at doses of 0.5 mg and 1.25 mg significantly reduced the risk of disability progression over the 24-month period (hazard ratio 0.70 and 0.68, respectively). The cumulative probability of disability progression (confirmed after 3 months) was 17.7% with 0.5 mg of fingolimod, 16.6% with 1.25 mg of fingolimod, and 24.1% with placebo. Both fingolimod doses were superior to placebo with regard to MRI-related measures (number of new or enlarged lesions on T2 -weighted images, gadolinium-enhancing lesions, and brain-volume loss at 24 months). Causes of study discontinuation and adverse events related to fingolimod included bradycardia and atrioventricular conduction block at the time of fingolimod initiation, macular edema, elevated liver-enzyme levels, and mild hypertension."

The authors concluded: "As compared with placebo, both doses of oral fingolimod improved the relapse rate, the risk of disability progression, and end points on MRI. These benefits will need to be weighed against possible long-term risks."

The drop-out rate of nearly 20% deserved scrutiny. Results presented here suggest NNT of about 17 to prevent one case of disease progression with 2 years of treatment.

For the full abstract, click here.

N Engl J Med published online 20 January 2010 © 2010 to the Massachusetts Medical Society
A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis. Ludwig Kappos, Ernst-Wilhelm Radue, Paul O'Connor, et al. Correspondence to: Dr. Kappos: [email protected]

Category: N. Neurological. Keywords: multiple sclerosis, oral treatment, fingolimod, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 9 February 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.

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