Table 9Summary of the evidence by key question

Key questionStrength of evidenceConclusion
Key Question 1. What is the comparative effectiveness of disease-modifying treatments for multiple sclerosis, including use of differing routes and schedules of administration?Fingolimod 1.25 mg or 0.5 mg once daily vs. interferon beta-1a: Moderate
All others: Insufficient
Fingolimod 0.5 mg once daily and 1.25 mg once daily resulted in lower annualized relapse rates than interferon beta-1a (0.16, 0.20, 0.33 respectively; P< 0.001). Fingolimod 0.5 mg once daily and 1.25 mg once daily resulted in more patients having no confirmed relapse at 1 year compared with interferon beta-1a (82.5%, 80.5%, and 70.1% respectively); NNT, 8.3 for fingolimod 0.5 mg and 10 for 1.25 mg daily.
 Differences were not found between the lower dose of fingolimod and the higher dose.
 Rates of confirmed disability progression were low, and similar between groups.
Key Question 5. Do disease-modifying treatments for multiple sclerosis differ in harms?Fingolimod 1.25 mg or 0.5 mg once daily vs. interferon beta-1a: Moderate
All others: Insufficient
Higher rates of pyrexia (RR, 4.26 (2.62 – 6.97), Influenza- like illness (RR, 10.55 (6.39 – 17.57)), and myalgia (RR, 3.13 (1.76 – 5.59)) were found with interferon beta-1a, while a higher rate of increased alanine aminotransferase (RR, 3.52 (1.66 – 7.50)) was found with fingolimod.
 The rate of herpes zoster infections was similar between fingolimod 0.5 mg once daily and interferon beta-1a. Fingolimod 1.25 mg was associated with higher risk of herpes virus infections than fingolimod 0.5 mg (RR, 2.61; 95% CI, 1.75 to 5.49; NNH, 30) or interferon beta-1a (RR, 1.97; 95% CI, 1.01 to 3.86; NNH, 37).
 Macular edema occurred in 4 patients in the 1.25 mg fingolimod group (1%), 2 in the 0.5 mg group (0.5%), and none in the interferon group.
 After the first dose of fingolimod, 1.2% of patients taking 1.25 mg fingolimod, 0.6% taking 0.5 mg fingolimod, 0.2% taking placebo, and 0% taking interferon experienced bradycardia.
 The risk of discontinuing drug due to an adverse event increased with fingolimod 1.25 mg once daily compared with fingolimod 0.5 mg once daily (RR, 1.79 (1.11 to 2.89); NNH, 23) and with interferon beta-1a (RR, 2.69 (1.55 to 4.69); NNH, 16).
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 one disease-modifying treatment is more effective or associated with fewer adverse events?Age, gender, baseline disability score: Moderate
All others: Insufficient
Differences in efficacy based on age, gender, or baseline disability score were not found with fingolimod.

Abbreviations: NNH, number needed to harm; NNT, number needed to treat; RR, relative risk.

From: Summary

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 [Internet].
McDonagh M.
Portland (OR): Oregon Health & Science University; 2011 Feb.
Copyright © 2011 by Oregon Health & Science University.

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