Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis

January 01, 0001

Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis

In this 12-month, double-blind, double-dummy phase 2 trial investigators from multiple countries randomly assigned 1292 patients with relapsing-remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a (an established therapy for multiple sclerosis) at a weekly dose of 30 mcg.

They found: "A total of 1153 patients (89%) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod — 0.20 in the 1.25-mg group and 0.16 in the 0.5-mg group — than in the interferon group. MRI findings supported the primary results. No significant differences were seen among the study groups with respect to progression of disability. Two fatal infections occurred in the group that received the 1.25-mg dose of fingolimod: disseminated primary varicella zoster and herpes simplex encephalitis. Other adverse events among patients receiving fingolimod were nonfatal herpesvirus infections, bradycardia and atrioventricular block, hypertension, macular edema, skin cancer, and elevated liver-enzyme levels."

The authors concluded: "This trial showed the superior efficacy of oral fingolimod with respect to relapse rates and MRI outcomes in patients with multiple sclerosis, as compared with intramuscular interferon beta-1a. Longer studies are needed to assess the safety and efficacy of treatment beyond 1 year."

Lack of differences between groups in progression and concern about fatal infections with fingolimod are major concerns about this new drug.

For the full abstract, click here.

N Engl J Med published online 20 January 2010
© 2010 to the Massachusetts Medical Society
Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis. Jeffrey A. Cohen, Frederik Barkhof, Giancarlo Comi, et al. Correspondence to: Dr. Cohen: [email protected]

Category: N. Neurological. Keywords: multiple sclerosis, oral treatment, fingolimod, interferon beta- 1a, 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.