Transforming multiple sclerosis trials into practical reality

Comments on an article by Bhupendra Khatri et al. (see record [rid]2011-10856-019[/rid]). Khatri and colleagues report the results of a preplanned extension of TRANSFORMS.5 In the core study, patients were randomly assigned to receive two doses of fingolimod (oral 0·5 mg or 1·25 mg per day) or interferon beta-1a (intramuscular 30 μg per week). Patients who completed the 12-month double-blind treatment phase were eligible to enter the optional extension phase in which patients treated with fingolimod were continued on that treatment and those treated with interferon beta-1a were randomly reassigned (1:1) to receive 0·5 mg or 1·25 mg fingolimod. The extension study data are important and have direct relevance for clinical practice. Fingolimod was well tolerated in the extension study population,5 and the tolerability and safety profile closely resembled that known from previous trials. The extension study scenario mimics clinical practice since, at least in the countries in which fingolimod is approved as a second-line therapy, most patients switched to fingolimod will previously have been treated with interferon beta or glatiramer acetate. The extension of TRANSFORMS suggests that it is safe to switch directly from interferon beta-1a to fingolimod. Despite some clear limitations in the trial design and thus its interpretation, the TRANSFORMS extension study provides helpful and valid data on switching of treatment from interferon beta to fingolimod. (PsycInfo Database Record (c) 2022 APA, all rights reserved)