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Cover of Drug Class Review: Disease-Modifying Drugs for Multiple Sclerosis: Single Drug Addendum: Fingolimod

Drug Class Review: Disease-Modifying Drugs for Multiple Sclerosis: Single Drug Addendum: Fingolimod

Final Original Report

Drug Class Reviews

, PharmD.

Portland (OR): Oregon Health & Science University; .

Structured Abstract


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® 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.


Drug Effectiveness Review Project: Marian McDonagh, PharmD, Principal Investigator
Oregon Evidence-based Practice Center: Mark Helfand, MD, MPH, Director

Acknowledgments: We thank Leah Williams, our publications editor, for putting this report into its present form for you to read. We also thank Allison Low, BS, for assistance with data abstraction, retrieval of articles, and assistance with editing and formatting.

Funding: The Drug Effectiveness Review Project, composed of 12 organizations including 11 state Medicaid agencies, and the Canadian Agency for Drugs and Technology in Health commissioned and funded for this report. These organizations selected the topic of the report and had input into its Key Questions. The content and conclusions of the report were entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report.

Suggested citation:

McDonagh MS. Disease-modifying drugs for multiple sclerosis: Single drug addendum: Fingolimod. Final original report.

The Agency for Healthcare Research and Quality has not yet seen or approved this report

The purpose of Drug Effectiveness Review Project reports is to make available information regarding the comparative clinical effectiveness and harms of different drugs. Reports are not usage guidelines, nor should they be read as an endorsement of or recommendation for any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports.

Copyright © 2011 by Oregon Health & Science University.
Bookshelf ID: NBK65419PMID: 22132431


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