Baseline Characteristics of Pediatric Patients with Multiple Sclerosis Enrolled in the PARADIGMS Study: A Randomized, Double-Blind Study of Fingolimod versus Interferon-β-1a (P1.347)

Objective: To present baseline characteristics of the first 190 patients randomized in the PARADIGMS study. Background: The PARADIGMS study is the first global, controlled study investigating the efficacy and safety of fingolimod up to 0.5 mg vs interferon (IFN) β-1a in pediatric patients. Approximately 3–5% of patients with multiple sclerosis (MS) experience disease onset before 18 years of age. Design/Methods: PARADIGMS is an ongoing 24-month, double-blind, double-dummy, randomized, active-controlled, parallel-group, multicenter study. Patients with MS aged between 10 to Results: The mean±SD age of the patients was 15.3±1.82 years (41% in u003e14 to ≤16 years; 31% inu003e16 years and 10% in ≤12 years). The majority of patients were female (63%) and Caucasian (88%). Only 6 (3%) patients were pre-pubertal (Tanner Stage Conclusions: Patients enrolled in the PARADIGMS study had a high frequency of relapses and Gd+ lesions early in their course of the disease and the majority were at post-pubertal stage. These characteristics are in line with the previously known pediatric MS cohorts. The recruitment target has been successfully met; however recruitment remains open to enroll additional eligible pre-pubertal patients. Study Supported by: Novartis Pharma AG. Disclosure: Dr. Chitnis received personal compensation for activities with Roche-Genentech and Sanofi-Genzyme. Dr. Chitnis received research support from EMD Serono, Biogen, Novartis and Verily. Dr. Arnold has received personal compensation for activities with Coronado Biosciences, Consortium of Multiple Sclerosis Centers, Eli Lilly, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, MS Forum, NeuroRx Research, Novartis, Opexa Therapeutics, Roche, Merck Serono, S.A. Serono Symposia International Foundation, Teva, the Canadian Institutes of Health Research, and the Multiple Sclerosis Society of Canada. Dr. Arnold holds stock and/or stock options in NeuroRx Research. Dr. Banwell has received personal compensation for activities with Novartis. Dr. Banwell has received personal compensation in an editorial capacity for Multiple Sclerosis and Related Disorders. Dr. Brueck has received personal compensation for activities with Bayer Vital, Biogen, Merck Serono, Teva Pharma, Genzyme, Sanofi Aventis, and Novartis as a lecturer or member of scientific advisory boards. Dr. Ghezzi has received personal compensation for activities with Biogen Idec, Merk-Serono, Novartis, Genzyme, TEVA, Serono Symposia Int Found., Almirall, as a speaker, consultant or member of the scientific advisory board. Dr. Giovannoni has received personal compensation for activities with AbbVie, Bayer HealthCare, Biogen, Canbex, FivePrime, Genzyme, GlaxoSmithKline, GW Pharma, Merck Serono, Novartis, Protein Discovery Laboratories, Roche, Synthon, Teva Neuroscience, UCB, and Vertex for honoraria. Dr. Giovannoni has received personal compensation from Elsevier in a co-chief editor capacity of MS and Related Disorders. Dr. Giovannoni has received research support from Biogen, Ironwood, Merck Serono, Merz, and Novartis. Dr. Greenberg has received personal compensation for activities with Novartis Boston Pharmaceuticals, and MSAA. Dr. Greenberg has received personal compensation in an editorial capacity for JAMA Neurology. Dr. Greenberg has received research support from Medimmune, Acorda, and Chugai. Dr. Krupp has received licensing and/or royalty fees from Johnson and Johnson, AbbVie, and Grifols. Dr. Rostasy has received personal compensation for activities with Merck Serono as a consultant and speaker. Dr. Tardieu has nothing to disclose. Dr. Waubant has received research support from Roche, Biogen Idec and Novartis. Dr. Wolinsky has received personal compensation for activities with AbbVie, AcademicCME, Alkermes, Bayer HealthCare, Forward Pharma A/S, Novartis, Roche/Genentech, Sanofi Genzyme, Takeda, Teva Pharmaceuticals, and WebMD. Dr. Wolinsky has received royalty payments from University of Texas Health Science Center at Houston. Dr. Bar-Or has received personal compensation for activities with Bayer, Bayhill Therapeutics, Berlex, Biogen Idec, BioMS, Diogenix, and Eli Lilly for consulting, serving on scientific advisory boards and/or as a speaker. Dr. Stites has received personal compensation for activities with Novartis Pharmaceuticals Corporation as an employee. Dr. Jessop has received personal compensation for activities with Novartis as an employee. Dr. Merschhemke has received personal compensation for activities with Novartis as an employee. Dr. Gaertner has received personal compensation from Bayer Vital, Biogen, Merck Serono, Teva, and Novartis as a consultant and for honoraria. Dr. Gaertner has received research support from Novartis and Biogen.