RT Journal Article
SR Electronic
T1 Real-world persistence and benefit–risk profile of fingolimod over 36 months in Germany
JF Neurology - Neuroimmunology Neuroinflammation
JO Neurol Neuroimmunol Neuroinflamm
FD Lippincott Williams & Wilkins
SP e548
DO 10.1212/NXI.0000000000000548
VO 6
IS 3
A1 Tjalf Ziemssen
A1 Michael Lang
A1 Björn Tackenberg
A1 Stephan Schmidt
A1 Holger Albrecht
A1 Luisa Klotz
A1 Judith Haas
A1 Christoph Lassek
A1 C. Anne-Marie Couto
A1 John A. Findlay
A1 Christian Cornelissen
A1 on behalf of the PANGAEA study group
YR 2019
UL http://nn.neurology.org/content/6/3/e548.abstract
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