Relapse Outcomes in Fingolimod-Treated Patients Previously Exposed to Natalizumab: Post-Hoc Analysis from the 4-Month, Open-Label FIRST Study (P07.103)

OBJECTIVE: To report relapse outcomes in relapsing multiple sclerosis (MS) patients treated with natalizumab prior to enrollment into the Fingolimod Initiation and caRdiac Safety Trial (FIRST) with fingolimod (0.5mg). BACKGROUND: The FIRST study was the first investigation in the fingolimod trial program to include patients who had been exposed to natalizumab up to 3 months prior to the study baseline. DESIGN/METHODS: 254 of 2417 enrolled relapsing MS patients had been previously exposed to natalizumab; 240 (94.5%) completed the study. Assessments included number, duration, severity and treatment of relapses. 135 patients received natalizumab more than 6 months before baseline (>6m group) and 119 patients received natalizumab between 3 and 6 months prior to baseline (3-6m group). 2163 patients had not been exposed to natalizumab (no natalizumab). RESULTS: In the first month of fingolimod treatment the proportion of patients with relapses was higher in the 3-6m group compared to the no natalizumab group (16.8% vs 4.9%) with an intermediate value for the >6m group (9.0%). In the second month of fingolimod treatment the proportion of patients with attacks decreased in all groups, with a larger reduction in the 3-6m group (16.8% to 5.9%) and remained low until the end of the study (month 4): 1.7% in 3-6m group, 3.8% in the >6m group and 1.6% in the no natalizumab group. Most relapses resulted in partial or complete recovery in both natalizumab-exposed groups (81.6% in >6m and 90.7% in 3-6m group) as well as in the no natalizumab group (85.3%). In the natalizumab-exposed groups there were no relapse-related study-drug discontinuations or study-drug interruptions. CONCLUSIONS: Patients with recent discontinuation of natalizumab had a higher risk of relapse which was in most cases improved with ongoing fingolimod treatment. No notably severe relapses were observed in this short term interventional safety study. Supported by: Novartis Pharma AG, Basel, Switzerland. Disclosure: Dr. Comi has received personal compensation for activities with Novartis, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Merck Serono, and Bayer Schering. Dr. Gold has received personal compensation for activities with Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Gold has received personal compensation in an editorial capacity for Therapeutic Advances in Neurological Disorders. Dr. Gold has received a license fee from Biogen Idec. Dr. Gold has received research support from Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Dahlke has received personal compensation for activities with Novartis. Dr. Sinha has received personal compensation for activities with Novartis as an employee. Dr. Von Rosenstiel has received personal compensation for activities with Novartis. Dr. Tomic-Wallis has received personal compensation for activities with Novartis as an employee. Dr. Kappos has receied personal compensation for activities with Actelion, Advancell, Allozyne, BaroFold, Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Bayhill, Biogen Idec, BioMarin, CLC Behring, Elan, Genmab, Genmark, GeNeuro SA and GlaxoSmithKline. Dr. Kappos has received research support from has received research support from Acorda, Actelion, Allozyne, BaroFold, Bayer HealthCare, Bayer Schering, Bayhill Therapeutics, Biogen Idec, Boehringer Ingelheim, Eisai, Elan, Genmab, GlaxoSmithKline, Glenmark, Merck Serono, MediciNova and Nova.