Background: Fingolimod is a high-efficacy disease-modifying therapy for multiple sclerosis (MS) and was the first oral treatment approved for the disease. Adverse events include bradyarrhythmia, hypertension, macular oedema and increased risk of infections, mainly due to its main mechanism of action, the non-selective modulation of sphingosine-1-phosphate receptor.
Methods and Results: We report the baseline characteristics, effectiveness outcomes and adverse events of a prospective cohort of 177 patients with a median treatment duration of 24 months, in which four patients (2.3%) presented with otherwise non-provoked peripheral vascular events (PVE).
Conclusions: Further studies are still needed to evaluate the frequency and severity of PVE in fingolimod patients.
Competing Interests: Declaration of Competing Interest EC received the ECTRIMS Clinical Fellowship (2013-2014), ECTRIMS travel grant awards, and academic travel support from Novartis, Genzyme, Merck, Biogen and Roche, has been a member of advisory boards at Genzyme, Biogen, Merck and Novartis, has received sub-investigator fees from the ISS “Social Cognition in MS” project at Teva and sub-investigator fees from project CORFO 14PIE-26946 - InnoBioscience SpA. RUSM received academic travel support from Novartis, Genzyme, Merck, Biogen and Roche, has been a member of advisory boards at Genzyme, Biogen, Merck and Novartis. CC received academic travel support from Novartis, Genzyme, Merck, Biogen and Roche, has been a member of advisory boards at Genzyme, Biogen, Merck and Novartis, has received PI fees from the ISS “Social Cognition in MS” project at Teva, and PI fees from project CORFO 14PIE-26946 - InnoBioscience SpA. CP nothing to disclose. BS received academic travel support from Novartis, Teva, Merck and Biogen AR and EV nothing to disclose.
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