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Medical information request
Medical information request

TRANSFORMS

Study design

Double-blind, randomized, double-dummy, active-controlled, one-year Phase 3 study in adults with RRMS

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A 1-year, randomized, double-blind, double-dummy, active-controlled (IFNβ-1a IM), phase 3 study of 1,292 adults with RRMS
Patients were randomly assigned to receive a once-daily dose of fingolimod 0.5 mg (n=431) or 1.25 mg (n=426) or IFNβ-1a IM injection at a weekly dose of 30 μg (n=435) for 1 year
Patient baseline characteristics:
                1. Between 18 and 55 years of age
                2. A diagnosis of RRMS with at least 1 documented relapse during the previous year or at least 2 documented relapses during the previous 2 years
                3. A score of 0.0 to 5.5 on the EDSS. Median score at baseline was 2.0
                4. Previous therapy with either any type of interferon-beta or glatiramer acetate was not a criterion for exclusion
Primary end point: the primary objective was to demonstrate that fingolimod 0.5 mg was superior to IFNβ-1a in terms of ARR in patients with RRMS treated for up to 12 months
Two key secondary end points: number of new or newly enlarged hyperintense lesions on T2-weighted MRI scans at 1 year and the time to 3-month confirmed disability progression as measured by at least a 1-point increase from baseline in EDSS (0.5-point increase for patients with baseline EDSS of 5.5) sustained for 3 month

AE profile of fingolimod versus interferon over 1 year: TRANSFORMS Core study​1

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AE profile of fingolimod over 4.5 years: TRANSFORMS Extension study2​**

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**All patients received fingolimod 0.5 mg in the extension 
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Abbreviations
ARR, annualized relapse rate; AE, adverse event; EDSS, Expanded Disability Status Scale; IFNβ-1a IM, interferon beta-1a intramuscular; MRI, magnetic resonance imaging; RRMS, relapsing-remitting multiple sclerosis; qd, once-daily
References
1. Cohen JA, et al; for TRANSFORMS Study Group. N Engl J Med. 2010.362(5):402-415.
2. Cohen JA, et al; for TRANSFORMS Study Group. J Neurol Neurosurg Psychiatry. 2016;87(5):468-475.
* Indication wording varies in different countries. The current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of fingolimod in the individual country.