To assess the long-term real-world benefit–risk profile of fingolimod in patients with relapsing MS in Germany.
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.
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.
(1) Bayer Healthcare (2) Biogen Idec (3) Novartis (4) Merck Serono (5) Teva (6) Genzyme (7) Roche (8) Celgene; all commercial
Speaker honorarium for all commercial entities (1) Bayer Healthcare (2) Biogen Idec (3) Sanofi Genzyme (4) Celgene (5) Roche (6) Novartis (7) Teva (8) Almirall (o) Merck
Served on scientific advisory boards for (1) Biogen-idec Germany and USA, (2) Bayer Healthcare Germany and USA, (3) Novartis Germany and Int(4) Merck-Serono Germany and Int, (5) Octapharma Germany, (6) CSL Behring Germany, (7) GRIFOLS Germany and Int, (8) Alexion Int, (9) Celgene Int, (10) Sanofi Genzyme Int
received speaker honoraria from (1) Biogen-idec Germany and USA, (2) Bayer Healthcare Germany and USA, (3) Novartis Germany and Int(4) Merck-Serono Germany and Int, (5) Octapharma Germany, (6) CSL Behring Germany, (7) GRIFOLS Germany and Int, (8) Alexion Int, (9) Celgene Int, (10) Sanofi Genzyme Int
received Consultancy fees from (1) Biogen-idec Germany and USA, (2) Bayer Healthcare Germany and USA, (3) Novartis Germany and Int(4) Merck-Serono Germany and Int, (5) Octapharma Germany, (6) CSL Behring Germany, (7) GRIFOLS Germany and Int, (8) Alexion Int, (9) Celgene Int, (10) Sanofi Genzyme Int
(1) Bayer Healthcare, (2) Biogen-idec Int, (3) Novartis Germany, (4) Sanofi-Aventis Germany
F?rderverein Neurologie e. V. (FN) German Myasthenia gravis Society (DMG) German Society of Neurology (DGN)
(1) Novartis; (2) Merck Serono; (3) Bayer Vital; (4) Biogen Idec; (5) Genzyme; (6) TEVA
(1) Novartis; (2) Merck Serono; (3) Bayer Vital; (4) Biogen Idec; (5) Genzyme; (6) TEVA
Bayer Vital. Grant for a clinical study entitled: Aerobic endurance exercise in mildly disabled MS patients
(1) Novartis, speaker honoraria and travel support (2) Merck Serono, speaker honoraria and travel support (3) Biogen, speaker honoraria and travel support (4) Roche, speaker honoraria and travel support (5) Genzyme, speaker honoraria and travel Support (6) CSL Behring, speaker honoraria and travel Support
(1) (CRC) SFB TR-128 Impact of dietary factors on the gut-CNS-axis ? implications for CNS autoimmunity A08, Project leader, 2016-2020 (2) (CRC) SFB 1009 ?Immune-cell interactions with endothelial cells and pericytes at the blood-brain- barrier: mechanisms and consequences? A03, Sub-project Leader, 2012-2020 (3) CRC; ?The role of the nuclear receptor NR4A1 in acute ischemic stroke: pathophysiology, therapy evaluation and human translation';Sub-Project leader, 2018-2020 (4) Federal Ministry of Education and Research (BMBF) Competence Network Multiple Sklerose: ?Multi-parameter immune cell-profiling: identification of biosignatures to understand heterogeneity, prognosis and treatment response factors in MS?, 3.1 Sub-project Leader, 2016-2020
(1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018
1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018
1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018
1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018
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