Abstract Details

Title Effect of Switching from Intramuscular Interferon b-1a to Fingolimod on Time to Relapse in Patients with Relapsing-Remitting Multiple Sclerosis Enrolled in a 1-Year Extension of TRANSFORMS

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 107

Objective

Background BACKGROUND: In TRANSFORMS, a 12-month, phase 3, randomized, double-blind trial, oral fingolimod 0.5 or 1.25 mg significantly reduced the annualized relapse rate (ARR) by 52% and 38%, respectively, compared with IFNb-1a IM 30 [mu]g once weekly in patients with relapsing-remitting multiple sclerosis (RRMS). In a 1-year extension, IFNb-1a IM patients were re-randomized to fingolimod 0.5 or 1.25 mg; ARR was reduced by 30% and 36%, respectively, compared with the previous 12 months.

Design/Methods DESIGN/METHODS: The analysis included patients who switched from IFNb-1a IM to fingolimod during the extension (intent-to-treat). The Branson and Whitehead switch model (Branson M and Whitehead J. Stats Med. 2002;21:2449-2463) was used to estimate the ratio of the observed time to first confirmed relapse to the estimated time to first relapse if the patient had remained on IFN b-1a IM. Ratios >1 (greater time to relapse) show a benefit of switching to fingolimod.

Results RESULTS: Of 431 patients who received IFNb-1a IM in the original trial, 341 entered the extension; 167 switched to fingolimod 0.5 mg and 174 switched to fingolimod 1.25 mg. Overall, 31 patients had a relapse after switching. The estimated ratio of observed time to relapse vs estimated time was 2.09 (95% CI, 1.45-3.04; n=16) for the IFNb-1a IM to fingolimod 0.5 mg switch group and 1.84 (95% CI, 1.30-2.65; n=15) for the IFNb-1a IM to fingolimod 1.25 mg switch group.

Conclusions CONCLUSIONS: Observed time to first confirmed relapse after switching from IFN?-1a IM to fingolimod was approximately 2-fold longer than the estimated time to relapse had patients remained on IFN?-1a IM, complementing previous findings suggesting the benefit of switching.

Authors/Disclosures
PRESENTER	No disclosure on file
Gary R. Cutter, PhD (University of Alabama At Birmingham)	Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for onsulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP, Tenmile.. Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb, CSL Behring, Cynata Therapeutics, DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Peter S. Chin, MD (Denali)	No disclosure on file
Ron Hashmonay, MD	No disclosure on file
	No disclosure on file
	No disclosure on file

��ɫ��

��ɫ��