PANGAEA: 5 years effectiveness of fingolimod in daily clinical practice (P6.393)

Objective: PANGAEA is a non-interventional study, conducted in Germany, to investigate long-term safety, effectiveness and patient reported outcomes in daily clinical practice. Background: Once-daily fingolimod (Gilenya®) is a sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing MS. As of June 2017 more than 213.000 patients have been treated with fingolimod; total patient exposure exceeds 453.000 patient-years. Design/Methods: Recruitment into the study finished in December 2013. 4229 patients from 374 centers were enrolled. 3,179 patients were treated with fingolimod for the first time. By Jan 2018 over 800 patients finished the 5 year documentation period of fingolimod treatment. Results: The proportion of female patients was 71.6 % and the mean age was 39.9 (± 10.1SD) years. The mean annual relapse rate of PANGAEA patients improved from 1.6 ± 0.12 (95%CI; baseline) to 0.28 ± 0.07 in the third year of treatment and remained stable over the following two years. The mean baseline EDSS in PANGAEA was 3.0 (±0.03; 95%CI))and remained stable over 5 years. In each year of treatment app. 90% of the patients had a stable EDSS or experienced a 6 months confirmed improvement. In each year of treatment between 60.4% (year 1) and 71.1% (year 5) of the patients were free of relapses and 6 months confirmed disability progression. 42.8% of the patients neither had a relapse nor a 6 months confirmed disability progression over 4 years of treatment. Patient reported outcomes (EQ-5D, TSQM-9) evaluated in a substudy (n=830) over a period of 24 months confirmed the good effectiveness and convenience profile of fingolimod from a patient point of view. Conclusions: The results of the 5 year interim analysis of PANGAEA support the positive effectiveness profile of fingolimod demonstrated in phase III clinical trials with real world evidence data. Study Supported by: This study was funded by the Novartis Pharma GmbH, Nuremberg, Germany Disclosure: Dr. Ziemssen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Biogen, Bayer, Merck, Novartis, Roche, Sanofi, Teva for the consulting and speaking services. Dr. Ziemssen has received research support from Bayer, Biogen, Novartis, Teva, Sanofi Aventis. Dr. Albrecht has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Bayer Healthcare, Biogen Idec, Merck Serono, Genzyme, Novartis, Sanofi-Aventis, and Teva. Dr. Haas has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer Vital, Biogen Idec, CSL Behring, Grifols, Merck Serono, Novartis, Octapharma, Roche, Sanofi Genzyme, Teva, and UCB. Dr. Klotz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received compensation for serving on Scientific Advisory Boards for Genzyme and Novartis; received speaker honoraria and travel support from Novartis, Merck Sorono, and Genzyme and Biogen; and receives research support from Novartis and Biogen. Dr. Klotz has received research support from received compensation for serving on Scientific Advisory Boards for Genzyme and Novartis; received speaker honoraria and travel support from Novartis, Merck Sorono, and Genzyme and Biogen; and receives research support from Novartis and Biogen. Dr. Lang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen Idec, Merck Serono, Novartis, Sanofi Genzyme, and Teva. Dr. Lassek has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Genzyme, Novartis, Teva. Dr. Lassek has received research support from Biogen, Genzyme, Novartis, Teva. Dr. Schmidt has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, and Teva. Dr. Tackenberg has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer Healthcare, Biogen, CSL Behring, GRIFOLS, Merck Serono, Novartis, Octapharma, Roche, Sanofi Genzyme, TEVA und UCB Pharma. Dr. Tackenberg has received personal compensation in an editorial capacity for Frontiers Neurology. Dr. Tackenberg has received research support from Biogen, Novartis, Merck. Dr. Cornelissen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis Pharma GmbH.