DX11
Efficacy and Safety of Fingolimod in Hispanic Patients: Pooled Data from Three Phase 3 Clinical Trials

Thursday, May 29, 2014
Trinity Exhibit Hall
Angel R Chinea Martinez, MD , San Juan Multiple Sclerosis Center, San Juan, PR
Davorka Tomic, MD , Novartis Pharma AG, Basel, Switzerland
Xiangyi Meng, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Kathleen Hawker, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ



Background: Multiple sclerosis (MS) is increasingly recognized among individuals living in Latin America and Hispanic people living in the USA. There is a need to characterize the efficacy and safety profiles of fingolimod in Hispanic patients.

Objectives: To assess the efficacy and safety of fingolimod in Hispanic patients with relapsing–remitting MS (RRMS) in a pooled population from three controlled phase 3 trials (FREEDOMS, FREEDOMS II and TRANSFORMS).

Methods: FREEDOMS and FREEDOMS II compared the efficacy and safety of once-daily fingolimod (0.5 mg and 1.25 mg) with placebo over 2 years; TRANSFORMS compared fingolimod (0.5 mg and 1.25 mg) with weekly intramuscular interferon
β-1a (IFNβ-1a IM; 30 µg) over 1 year. In the pooled Hispanic subgroup, annualized relapse rates (ARRs) were assessed using a negative binomial regression model with treatment, study, number of relapses in the previous 2 years and baseline Expanded Disability Status Scale score as exploratory variables, and duration of exposure as an offset variable. All adverse events (AEs) and serious AEs (SAEs) were recorded. Results presented here focus on the approved fingolimod 0.5 mg dose.

Results: Hispanic patients receiving fingolimod (0.5 mg; n = 89), placebo (n = 27) and IFNβ-1a IM (n = 65) had ARRs of 0.22 (95% confidence interval [CI]: 0.14–0.35), 0.46 (95% CI: 0.24–0.88) and 0.46 (95% CI: 0.18–0.63), respectively, equating to a 52% ARR reduction with fingolimod relative to both placebo and IFNβ-1a IM. Overall, 7.9% of patients in the fingolimod 0.5 mg group discontinued owing to an AE compared with 11.1% in the placebo and 1.5% in the IFNβ-1a IM groups. SAEs were reported in 7.9% (fingolimod 0.5 mg), 3.7% (placebo) and 1.5% (IFNβ-1a IM) of patients. No novel safety events were apparent in this subgroup.

Conclusions: In this post hoc subgroup analysis based on three pooled fingolimod phase 3 trials, Hispanic patients with RRMS treated with fingolimod had less relapse activity than those receiving placebo or IFNβ-1a IM, confirming efficacy of fingolimod in this subgroup. The efficacy and safety profiles were consistent with those of the overall study population.