Two-year macular volume assessment in multiple sclerosis patients treated with fingolimod
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Two-year macular volume assessment in multiple sclerosis patients treated with fingolimod Alessandro d’Ambrosio 1 & Rocco Capuano 1 & Settimio Rossi 2 & Alvino Bisecco 1 & Michele Lanza 2 & Carlo Gesualdo 2 & Letizia Leocani 3 & Mariaemma Rodegher 3 & Massimo Filippi 3 & Clara Marino 4 & Davide Maimone 5 & Gioacchino Tedeschi 1 & Francesca Simonelli 2 & Antonio Gallo 1 Received: 13 August 2020 / Accepted: 5 October 2020 # Fondazione Società Italiana di Neurologia 2020
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. Keywords Multiple sclerosis . Macular volume . Fingolimod . Safety . Optical coherence tomography
Introduction Fingolimod (FNG)—an approved drug for the treatment of relapsing remitting multiple sclerosis (RRMS)—is associated with cystoid macular edema (ME) in a small subset of patients, presenting with an acute, painless, and mostly d’Ambrosio Alessandro and Capuano Rocco share the first authorship * Antonio Gallo [email protected] 1
Multiple Sclerosis Center, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy
2
Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy
3
Neurology Unit and Neurophysiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
4
Ophtalmology Unit, ARNAS Garibaldi Hospital, Catania, Italy
5
Multiple Sclerosis Center, Neurology Unit, ARNAS Garibaldi Hospital, Catania, Italy
reversible visual acuity drop [1, 2]. This adverse event might be linked to the effect of FNG on its main target, the sphingosine-1-phosphate (S1P) receptor, that is also expressed on the blood-retina barrier endothelium [1, 2]. Spectral domain optical coherence tomography (SD-OCT) is considered a very sensitive tool (more than fundus examination) for ME detection, even in a presymptomatic stage [3]. Previous real-life studies showed that, independently of visual symptoms, an increase in the total macular volume (TMV) can be detected in a rather large percentage of patients during the first months af
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