Interim Results of the PANGAEA and PEARL Studies, Comparing Treatment Satisfaction and Pharmaco-Economic Data of Fingolimod (Gilenya®) and First-Line Therapies in Multiple Sclerosis Patients in Germany (P03.220)

OBJECTIVE: To investigate the safety and efficacy of fingolimod in daily practice, a large national 5-year non-interventional study (NIS) is being conducted (PANGAEA). A further NIS (PEARL) collects analogous data in a first-line setting, allowing comparison of treatment satisfaction and health resource utilization between fingolimod and first-line therapy. BACKGROUND: Fingolimod is licensed in the European Union as escalation treatment for patients with relapsing-remitting multiple sclerosis (RRMS); its efficacy has been demonstrated in a large clinical trial program, but data from everyday settings are not yet available. DESIGN/METHODS: Already 1800 patient in the PEARL study and 200 patients of the PANGAEA study have completed month 9 and are part of this analysis. RESULTS: The populations are comparable regarding gender and age with a slight difference in disease duration (8.4 vs 5.4 years, fingolimod vs first-line). 98.8 % of the fingolimod patients but only 66.1 % of the patients with first-line therapy found their medication easy to take (easy: 5.4 vs 26.6 %; very easy 6.6 vs 20.0 %; extremely easy 86.7 vs 19.5 %, fingolimod vs first-line). Twice as many patients receiving fingolimod are overall extremely satisfied with their medication (42.2 vs 21.4 %). The relative number of sick certificates was comparable (9.5 % vs 10.2 %), the median number of days absent from work, however, was three times lower in patients receiving fingolimod (5±6.45 vs 14±26.54; days±SD). CONCLUSIONS: These first results suggest that patients are more satisfied with fingolimod, which is taken orally once daily, compared to injectable first-line IFN-beta and GA. This might translate to better compliance and effectiveness. . Apart from that, the lower count of sick days under fingolimod holds a chance of reducing health costs caused by MS-related sick-leave. Supported by: Novartis Pharma GmbH. Disclosure: Dr. Ziemssen has received personal compensation for activities with Almirall, Biogen Idec, Bayer Pharmaceuticals Corporation, Genzyme Corporation, GlaxoSmithKline, Merck Sharp & Dohme Limited, Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals, Inc., Teva Neuroscience, Synthon as a consultant. Dr. Ziemssen has received research support from Biogen Idec, Bayer Pharmaceuticals Corporation, Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals, Inc. and Teva Neuroscience. Dr. Vollmar has nothing to disclose. Dr. Meergans has received personal compensation for activities with Novartis Pharma GmbH as an employee. Dr. Tracik has received personal compensation for activities with Novartis. Dr. Lorente has received personal compensation for activities with Novartis. Dr. Neidhardt has received personal compensation for activities with Novartis. Dr. Van Lokven has received personal compensation for activities with Novartis as an employee.