James Hughes, MD
In patients with relapsing–remitting multiple sclerosis (MS), what are the relative efficacy and safety of oral fingolimod compared with intramuscular interferon β-1a?
Randomized controlled trial (Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing–Remitting Multiple Sclerosis [TRANSFORMS]). ClinicalTrials.gov NCT00340834.
Blinded (patients, clinicians, study personnel, outcome assessors, steering-committee members, and study statistician).*
172 centers in 18 countries.
1292 patients 18 to 55 years of age (mean age 36 y, 67% women) who had been diagnosed with MS that met the revised McDonald criteria and had a relapsing–remitting course, had had ≥ 1 documented relapse in the previous year or ≥ 2 documented relapses in the previous 2 years, and scored 0 to 5.5 on the Expanded Disability Status Scale (range 0 to 10, worst). Exclusion criteria were documented relapse or corticosteroid treatment in ≤ 30 days, active infection, macular edema, immunosuppression, and clinically important comorbidity.
Oral fingolimod, 1.25 mg/d (n = 426) or 0.5 mg/d (n = 431), or intramuscular interferon β-1a, 30 µg/wk (n = 435), for 12 months.
Annualized relapse rate (number of confirmed relapses during a 12-mo period), number of new or enlarged hyperintense lesions on T2-weighted magnetic resonance imaging scans, confirmed disability progression, and adverse events.
89% (intention-to-treat analysis).
Compared with the interferon group, both fingolimod groups had lower relapse rates (with no difference between fingolimod doses), larger proportions of patients without relapse, longer time to first relapse, and fewer new or enlarged lesions (Table). Groups did not differ for proportion of patients without confirmed disability progression (Table). Serious adverse events were reported for 11% of the 1.25-mg fingolimod group (including 2 deaths related to herpesvirus infection), 7.0% of the 0.5-mg fingolimod group, and 5.8% of the interferon group, with the most frequent events being bradycardia, atrioventricular block, infection, and cancer.
In patients with relapsing–remitting multiple sclerosis, both doses of oral fingolimod were more effective than interferon β-1a but the higher dose was associated with more serious adverse events.
Fingolimod vs interferon β-1a for relapsing–remitting multiple sclerosis†
†SD = standard deviation; CI defined in Glossary. P < 0.001 for all comparisons between fingolimod and interferon, except for No disability progression (not significant).
Hughes J. Oral fingolimod was more effective than intramuscular interferon for relapsing–remitting multiple sclerosis. Ann Intern Med. 2010;152:JC5–6. doi: 10.7326/0003-4819-152-10-201005180-02006
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Published: Ann Intern Med. 2010;152(10):JC5-6.
Multiple Sclerosis, Neurology.
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