Efficacy And Safety Of Fingolimod In Hispanic Patients: Pooled Data From Three Phase 3 Clinical Trials (P2.208)

OBJECTIVE: To assess the efficacy and safety of fingolimod in Hispanic patients with relapsing-remitting multiple sclerosis (RRMS) from a pooled population from three controlled phase 3 trials (FREEDOMS, FREEDOMS II and TRANSFORMS). BACKGROUND: Multiple sclerosis (MS) is increasingly recognized amongst individuals living in Latin America and among Hispanics living in the USA. There is a need to characterize the efficacy and safety profile of fingolimod in Hispanic patients. DESIGN/METHODS: FREEDOMS and FREEDOMS II compared the efficacy and safety of once-daily fingolimod (0.5mg and 1.25mg) with placebo over 2 years; TRANSFORMS compared fingolimod (0.5mg and 1.25mg) with weekly intramuscular interferon beta-1a (IFNβ-1a; 30µg) over 1 year. In the pooled Hispanic subgroup, annualized relapse rate (ARR) was assessed using a negative binomial regression model with treatment, study, number of relapses in the previous 2 years and baseline Expanded Disability Scale Score as exploratory variables, and duration of exposure as an offset variable. All adverse events (AEs) and severe AEs (SAEs) were recorded. Results presented here focus on the approved fingolimod 0.5mg dose. RESULTS: Hispanic patients receiving fingolimod (0.5mg; n=89), placebo (n=27) and IFNβ-1a (n=65) had ARRs of 0.22 (95% CI, 0.14-0.35), 0.46 (95% CI, 0.24-0.88) and 0.46 (95% CI, 0.18-0.63), respectively, representing a 52% ARR reduction relative to both placebo and IFNβ-1a. Overall, 7.9%, 11.1% and 1.5% of patients discontinued owing to an AE in fingolimod 0.5mg, placebo and IFNβ-1a groups, respectively. SAEs were reported in 7.9% (fingolimod 0.5mg), 3.7% (placebo) and 1.5% (IFNβ-1a). No novel safety events were apparent in this patient subgroup. CONCLUSIONS: In this post hoc subgroup analysis based on three pooled fingolimod phase 3 trials, Hispanic patients with RRMS treated with fingolimod exhibited less relapse activity than patients receiving placebo or IFNβ-1a, confirming efficacy of fingolimod in this group. The efficacy and safety profile was consistent with the overall study population. Study Supported by: Novartis Pharmaceuticals Corporation. Disclosure: Dr. Chinea has nothing to disclose. Dr. Alvarenga has nothing to disclose. Dr. Tomic has received personal compensation for activities with Novartis as an employee. Dr. Tomic holds stock and/or stock options in Novartis. Dr. Dibernardo has received personal compensation for activities with Novartis as an employee. Dr. Dibernardo holds stock and/or stock options in Novartis. Dr. Meng has received personal compensation for activities with Novartis. Dr. Meng holds stock and/or stock options in Novartis which sponsored research in which Dr. Meng was involved as an investigator. Dr. Hawker has received personal compensation for activities with Novartis. Dr. Hawker holds stock and/or stock options in Novartis.