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Drug Class Review: Disease-Modifying Drugs for Multiple Sclerosis: Single Drug Addendum: Fingolimod
Drug Class Reviews
Marian McDonagh, PharmD.
Structured Abstract
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® 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.
Contents
- Introduction
- Methods
- Results
- Overview
- Key Question 1 What is the comparative effectiveness of fingolimod and other disease-modifying treatments for multiple sclerosis, including use of differing routes and schedules of administration?
- Key Question 2 [Do disease-modifying treatments for multiple sclerosis in effects on the development or recurrence of interferon beta neutralizing antibodies?]
- Key Question 3 [What is the evidence that interferon beta neutralizing antibody status has an impact on clinical outcomes (relapse and disease progression) in patients with multiple sclerosis?]
- Key Question 4 What is the effectiveness of fingolimod and other disease-modifying treatments for patients with a clinically isolated syndrome?
- Key Question 5 Do fingolimod and other disease-modifying treatments for multiple sclerosis differ in harms?
- Key Question 6 Are there subgroups of patients based on demographics (age, racial or ethnic groups, and gender), socioeconomic status, other medications, severity of disease, or co-morbidities for which fingolimod is more effective or associated with fewer adverse events than other disease-modifying treatment?
- Summary
- Conclusions
- References
- Appendixes
- Evidence Tables
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. http://derp.ohsu.edu/about/final-document-display.cfm
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.
- Review Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Final Update 1 Report[ 2010]Review Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Final Update 1 ReportSmith B, Carson S, Fu R, McDonagh M, Dana T, Chan BKS, Thakurta S, Gibler A. 2010 Aug
- Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.[N Engl J Med. 2010]Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al. N Engl J Med. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
- Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial.[Lancet Neurol. 2014]Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial.Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT, Vollmer T, Agius MA, Kappos L, Stites T, et al. Lancet Neurol. 2014 Jun; 13(6):545-56. Epub 2014 Mar 28.
- A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.[N Engl J Med. 2010]A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, et al. N Engl J Med. 2010 Feb 4; 362(5):387-401. Epub 2010 Jan 20.
- Review Drug Class Review: Drugs for Fibromyalgia: Final Original Report[ 2011]Review Drug Class Review: Drugs for Fibromyalgia: Final Original ReportSmith B, Peterson K, Fu R, McDonagh M, Thakurta S. 2011 Apr
- Drug Class Review: Disease-Modifying Drugs for Multiple Sclerosis: Single Drug A...Drug Class Review: Disease-Modifying Drugs for Multiple Sclerosis: Single Drug Addendum: Fingolimod
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