Comparison of first-line fingolimod efficacy compared with first-line interferon-beta or glatiramer therapy in MS patients with active disease using propensity-matched registry data (P3.247)

OBJECTIVE: Investigate time to relapse and discontinuation in a propensity-matched sample of MS patients on first-line fingolimod compared with first line interferon-beta (IFNβ) or glatiramer acetate (GA) following relapse. BACKGROUND: Outcomes in patients initiating first-line fingolimod relative to IFNβ or GA following relapse are not known. Comparisons of treatment effectiveness from observational registry data can be confounded as treatment assignments are non-random. Propensity score matching is a statistical technique to adjust for covariate imbalances across cohorts. DESIGN/METHODS: The MSBase study is a global, longitudinal registry for Multiple Sclerosis. At time of data extraction, the registry contained 31,429 patients from 104 centres across 30 countries. All patients included in the analysis had at least one relapse in the 12 months prior to baseline. First line fingolimod initiations were 1:1 propensity matched to first-line IFNβ/GA commencements using sex, age, country, disease duration, EDSS and pre-treatment relapse activity as baseline matching characteristics. Predictors of time to first relapse and time to treatment discontinuation were investigated using a clustered marginal Cox model. RESULTS: A total of 180 first-line fingolimod patients were successfully matched to 180 IFNβ/GA commencements. Relapse rate in first line fingolimod was 18.4 relapse per 100 person-years (95[percnt] CI 13.8-24.7) compared with 25.1 relapse per 100 person-years with first-line IFNβ/GA (95[percnt] CI 20.8, 30.2). First line fingolimod was associated with a 46[percnt] reduction in the rate of on-treatment relapse compared with first-line IFNβ/GA (HR 0.54, 95[percnt] CI 0.35-0.83). Similarly first-line fingolimod was associated with a 42[percnt] reduction in treatment discontinuation compared with IFNβ/GA (HR 0.58, 95[percnt] CI 0.34, 0.96). The restricted sample size did not permit meaningful comparisons of confirmed disability progression. CONCLUSIONS: The efficacy of fingolimod initiation, as assessed by time to first relapse and treatment discontinuation, was superior to that of IFNβ/GA in a first-line setting in propensity-matched MS patients. Disclosure: Dr. Spelman has received personal compensation for activities with Biogen Idec as a speaker. Dr. Bergvall has received personal compensation for activities with Novartis as an employee. Dr. Izquierdo has received personal compensation for activities with Biogen Idec, Merck & Co. Inc., Bayer Pharmaceuticals Corp., Sanofi-Aventis Pharmaceuticals Inc., Teva Neuroscience, and Novartis. Dr. Alroughani has received personal compensation for activities with Bayer, Biologix, GlaxoSmithKline, Inc., Merck-Sorono, Novartis, as an advisor and/or speaker. Dr. McCombe has received personal compensation for activities with Bayer Schering and Sanofi-Adventis Pharmaceuticals. Dr. Fernandez Bolanos has nothing to disclose. Dr. Horakova has received research support from Biogen Idec. Dr. Havrdovahas received personal compensation for activities with Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals Inc., Genzyme Corp., and Teva Neuroscience. Dr. Oreja-Guevara has received research support from Biogen Idec and Merck Serono. Dr. Lechner-Scott has received personal compensation for activities with Biogen Idec, Bayer Pharmaceuticals Corp., EDM Serono, and Sanofi-Aventis Pharmaceuticals as a consultant and/or speaker. Dr. Slee has nothing to disclose. Dr. Trojano has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals, Inc., Biogen Idec, Novartis and Bayer Schering Pharma as a consultant and/or speaker. Dr. Butzkueven has received personal compensation for activities with Novartis, Merck Serono, and Biogen Idec as a consultant and/or advisor.