Abstract/summary
Background
Fingolimod (FNG) is associated with the development of symptomatic macular edema (ME) in a small subset of multiple sclerosis (MS) patients. By using spectral domain optical coherence tomography (SD-OCT), an increase in the total macular volume (TMV) was rarely detected during the first months of treatment.
Objectives
The objective of this study is to assess whether FNG treatment leads to long-term macular changes in a real-life setting.
Methods
Sixty RRMS patients starting FNG, according to therapeutic indication, were enrolled at three Italian MS centers and followed for 2 years.
Results
The mean TMV did not change between baseline and the follow-up. No patients experienced visual acuity drop during the follow-up.
Conclusions
Initiation of FNG in MS is associated with a modest, not significant, increase in macular volume followed by no further significant changes over 2 years, highlighting the good safety profile of such treatment in MS.
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Acknowledgments
The authors would like to thank Federica Giuliano and Annamaria Avella for helping in data acquisition.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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Conflict of interests
AdA, RC, SR, ML, CG, LL, MR, DM, and CM have no disclosures. AB has received speaker honoraria and/or compensation for consulting service from Biogen, Merck, and Genzyme. MF serves on scientific advisory boards for Teva Pharmaceutical Industries Ltd. and Genmab A/S; has received funding for travel from Bayer Schering Pharma, Biogen-Dompe, Genmab A/S, Merck Serono, and Teva Pharmaceutical Industries Ltd.; serves as Co-Editor in Chief for Journal of Neurology; serves on editorial boards of the American Journal of Neuroradiology, BMC Musculoskeletal Disorders, Clinical Neurology and Neurosurgery, Erciyes Medical Journal, Journal of Neuroimaging, Journal of Neurovirology, The Lancet Neurology, Magnetic Resonance Imaging, Multiple Sclerosis, and Neurological Sciences; serves as a consultant to Bayer Schering Pharma, Biogen-Dompe, Genmab A/S, Merck Serono, and Teva Pharmaceutical Industries Ltd.; serves on speakers bureaus for Bayer Schering Pharma, Biogen-Dompe, Genmab A/S, Merck Serono, and Teva Pharmaceutical Industries Ltd.; and receives research support from Bayer Schering Pharma, Biogen-Dompe, Genmab A/S, Merck Serono, Teva Pharmaceutical Industries Ltd. and Fondazione Italiana Sclerosi Multipla. GT has received compensation for consulting services and/or speaking activities from Biogen, Novartis, Merck, Genzyme, Roche, Teva, and receives research support from Biogen Idec, Merck Serono, and Fondazione Italiana Sclerosi Multipla. AG received honoraria for speaking and travel grants from Biogen, Merck, Genzyme, Teva, Mylan, Roche, and Novartis.
Ethical approval
The Ethics Committee of each participating MS center approved the study protocol.
Informed consent
All participants provided written informed consent.
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d’Ambrosio Alessandro and Capuano Rocco share the first authorship
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d’Ambrosio, A., Capuano, R., Rossi, S. et al. Two-year macular volume assessment in multiple sclerosis patients treated with fingolimod. Neurol Sci 42, 731–733 (2021). https://doi.org/10.1007/s10072-020-04802-x
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DOI: https://doi.org/10.1007/s10072-020-04802-x