4 Years PANGAEA: Long Term Data on Effectiveness and Safety from Patients on Natalizumab Switching to Fingolimod in Real World (P6.188)

Objective: PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients) is a non-interventional study (NIS), conducted in Germany, to investigate long-term safety, tolerability and effectiveness in daily clinical practice. Here we present data from patients on natalizumab who switched to fingolimod. 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 December 2013. 4229 patients from 374 centers were enrolled. 714 patients switched to fingolimod from natalizumab. Results: This analysis included 714 patients that switched after a natalizumab wash out period to fingolimod. The mean duration since last natalizumab infusion was 178.4 ±203.74 days. Patients were stratified by wash out time before Fingolimod first dose in monthly intervals from ≤60 days to >300 days. Patient numbers in the wash out intervals were evenly distributed between 10[percnt] and 13[percnt]. The mean annualized relapse rate of this cohortwas 0.9 (±0.08, 95[percnt]CI). The number of relapses increased in the definedwash out intervals from 0.07 (≤60 days) to 0.7 (>300 days). The mean annualized relapse rate in year one of PANGAEA was 0.68 (±0.1, 95[percnt]CI). The relapse rate within the first year of PANGAEA increased dependent on the length of the natalizumab wash out period (0.43 ±0.133; ≤60 days; 0,67 ±0.358; >300 days). Relapse rates in year 2, 3 and 4 remained constant independent of the length of the natalizumab wash out period. Conclusions: A short natalizumab wash-out period is associated with lower clinical reactivation The relapse rate in the first half year of PANGAEA depends on the length of the natalizumab wash out phase prior the fingolimod first dose. 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.