4 Years Safety of Fingolimod in Real World: PANGAEA, a Non-Interventional Study of Safety, Effectiveness and Pharmacoeconomic Data for Fingolimod Patients in Daily Clinical Practice (P2.077)

Objective: PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients) is a non-interventional study, to investigate long-term safety, tolerability and effectiveness in daily clinical practice. Background: Once-daily fingolimod (Gilenya®, Novartis Pharma AG) is a sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing MS. More than 125.000 patients have been treated with fingolimod; total patient exposure now exceeds 240.000 patient-years. Design/Methods: Recruitment into the study finished in 2013. 4229 patients from 374 German centers were enrolled. In this interim-analysis we present safety data from patients that are treated with fingolimod for up to 4 years. Results: The proportion of female patients was 71.6[percnt] and the mean age(±SD) was 39.4(± 10.0) years. The mean time since diagnosis at baseline was 8.2±6.3 years. Study discontinuation rates in each year of treatment decrease from 14[percnt](year 1) to 12[percnt](year 3). Discontinuation rates due toadverse events decrease over time (4.7[percnt] first year; 2.3[percnt] second year of treatment). Proportion of patients discontinuing treatment due to lack of efficacy or disease progression remained low at 2.6[percnt] in year 1 and 3.1[percnt] at year 2. The safety profile of fingolimod in real life is comparable to that observed in phase III clinical trials. Common adverse events are related to the fingolimod mode of action (reductions in lymphocyte counts), increase in liver enzyme values, upper respiratory tract infections (e.g. nasopharyngitis, 9.9[percnt]; bronchitis, 2.4[percnt]; cough, 2.2[percnt]), and potentially MS related adverse events like fatigue(3.4[percnt]) and depression(2.6[percnt]). 45.4[percnt] of the patients experienced no adverse events so far. 3.9[percnt] off all adverse events were rated as serious. Conclusions: The results of the 4 year interim analysis of PANGAEA support the positive benefit-risk profile fingolimod demonstrated in phase III clinical trials with real world evidence data. The number of reported adverse events is consistent with previous findings from clinical trials. Disclosure: Dr. Ziemssen has received personal compensation for activities with Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceutical, and Almirall. Dr. Albrecht has received personal compensation for activities with Genzyme -Sanofi, Novartis, and Biogen. Dr. Haas has received personal compensation for activities with Bayer Schering, Teva Aventis, Merck Serono, Biogen Idec, Allergan Inc., Octapharma as a consultant. Dr. Klotz has received personal compensation from Genzyme, Novartis, Merck Serono, and CSL Behring as a speaker and/or advisor. Dr. Lang has received personal compensation for activities with Novartis, Biogen Idec, Bayer, Teva, EMD Serono and Genzyme. Dr. Lassek has received personal compensation for activities with Teva, EMD Serono, Genzyme, Novartis, Bayer, and Biogen,. Dr. Schmidt received personal compensation for activities with Bayer Vital, Biogen Idec, MerckSerono, Teva, Sanofi, and Novartis as a scientific advisory board member and a speaker. Dr. Tackenberg has received personal compensation for activities with Bayer Pharmaceuticals Corp., Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Tackenberg has received research support. Dr. Cornelissen has received personal compensation for activities with Novartis as an employee.