| Summary: | PURPOSE: We compared the effectiveness and harms of fingolimod (Gilenya) to other disease-modifying drugs in the treatment of multiple sclerosis. DATA SOURCES: We searched Ovid MEDLINE(r) and the Cochrane Library and the Database of Abstracts of Reviews of Effects through November 2010. For additional data we also hand searched reference lists, US Food and Drug Administration medical and statistical reviews, and dossiers submitted by pharmaceutical companies. REVIEW METHODS: Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to standard Drug Effectiveness Review Project review methods. RESULTS AND CONCLUSIONS: In patients with relapsing-remitting multiple sclerosis, fingolimod 0.5 mg and 1.25 mg once daily was superior to interferon beta-1a in improving relapse-related outcomes, including annualized relapse rates and proportion without relapse, over a 1 year period. Progression of disability was not different between the treatments at 12 months. The higher dose (1.25 mg once daily) of fingolimod resulted in higher numbers and more severe adverse events, including herpes zoster infections and symptomatic bradycardia after the first dose, as well as more patients discontinuing treatment. Differences in adverse events between 0.5 mg fingolimod (the dose approved by the US Food and Drug Administration) and interferon beta-1a were limited to more patients with pyrexia, myalgia, and flu-like symptoms with interferon, and more patients with elevated liver enzymes with fingolimod. While the absolute event rates were low, ongoing concerns with the safety of fingolimod included the risk of macular edema, the effect of lung function, cancers, and serious viral infections. Further studies are underway to better determine the risk with fingolimod
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