PT  - JOURNAL ARTICLE
AU  - Tjalf Ziemssen
AU  - Michael Lang
AU  - Björn Tackenberg
AU  - Stephan Schmidt
AU  - Holger Albrecht
AU  - Luisa Klotz
AU  - Judith Haas
AU  - Christoph Lassek
AU  - C. Anne-Marie Couto
AU  - John A. Findlay
AU  - Christian Cornelissen
AU  - on behalf of the PANGAEA study group
TI  - Real-world persistence and benefit–risk profile of fingolimod over 36 months in Germany
AID  - 10.1212/NXI.0000000000000548
DP  - 2019 May 01
TA  - Neurology - Neuroimmunology Neuroinflammation
PG  - e548
VI  - 6
IP  - 3
4099  - http://nn.neurology.org/content/6/3/e548.short
4100  - http://nn.neurology.org/content/6/3/e548.full
SO  - Neurol Neuroimmunol Neuroinflamm2019 May 01; 6
AB  - Objective To assess the long-term real-world benefit–risk profile of fingolimod in patients with relapsing MS in Germany.Methods This analysis used data from the noninterventional real-world study, Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA), to assess prospectively the persistence, effectiveness, and safety of fingolimod over 36 months (±90 days) in Germany. For inclusion in the effectiveness analysis (n = 2,537), patients were required to have received fingolimod for the first time in PANGAEA, to have at least 12 months of data, and to have completed each 12-month follow-up period. For the safety analysis (n = 3,266), patients were additionally allowed to have received fingolimod before enrollment.Results At baseline, 94.7% of patients in the effectiveness analysis had received a previous disease-modifying therapy. After 36 months, 70.4% of patients were still receiving fingolimod. Over this period, annualized relapse rates decreased to 0.265 (95% CI: 0.244–0.286) from 1.79 (95% CI: 1.75–1.83), and mean Expanded Disability Status Scale scores remained stable (mean change from baseline: +0.049 [95% CI: −0.015 to +0.114]). In total, 16% of patients had 6-month confirmed disability improvement, 12.5% had 6-month confirmed disability worsening, and 52.4% were free from relapses and 6-month confirmed disability worsening. Adverse events (AEs) and serious AEs were experienced by up to 23.4% and 3.9% of patients, respectively, during any of the 12-month follow-up periods. The frequency and nature of AEs were in line with previous findings.Conclusions Using systematically collected data from PANGAEA, this analysis demonstrates the sustained effectiveness, high persistence, and manageable safety profile of fingolimod over 36 months.AE=adverse event; ARR=annualized relapse rate; DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; PANGAEA=Post-Authorization Non-interventional German sAfety study of GilEnyA; RCT=randomized controlled trial; RMS=relapsing MS; SAE=serious AE; SmPC=summary of product characteristic