Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study
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ORIGINAL ARTICLE
Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study Giancarlo Comi 1 & Carlo Pozzilli 2,3 & Vincenzo Brescia Morra 4 & Antonio Bertolotto 5 & Francesca Sangalli 1 & Luca Prosperini 3,6 & Antonio Carotenuto 4 & Pietro Iaffaldano 7 & Marco Capobianco 5 & Delia Colombo 8 & Mihaela Nica 8 & Sara Rizzoli 9 & Maria Trojano 7 Received: 22 October 2019 / Accepted: 27 March 2020 # The Author(s) 2020
Abstract Background Fingolimod is the first oral agent approved for treatment of relapsing-remitting multiple sclerosis (RRMS). We aimed to evaluate fingolimod effectiveness in a real-world sample of RRMS patients. Methods A retrospective, multicentre study in patients treated with fingolimod, whom clinical and radiological data were collected in the 2 years preceding and following the initiation of fingolimod. Results Out of 414 patients, 56.8% received prior first-line injectable disease-modifying therapies, 25.4% were previously treated with natalizumab, 1.2% with immunosuppressant agents, and 16.7% were treatment naive. The annualized relapse rate decreased by 65% in the first year and by 70% after two years of treatment. Age ≤ 40 years, ≥ 1 relapse in the 24 months before fingolimod initiation and previous treatment with natalizumab were risk factors for relapses. Overall, 67.9% patients had no evidence of disease activity (NEDA3) after 1 year and 54.6% after 2 years of treatment. A higher proportion of naïve (81.2% in 1 year and 66.7% after 2 years) or first-line injected patients (70.2% and 56.6%) achieved NEDA-3 than those previously treated with natalizumab (54.3% and 42.9%). Conclusions Fingolimod appeared to be effective in naive patients and after first-line treatment failure in reducing risk of relapse and disease activity throughout the 2-year follow-up. Keywords Relapsing-remitting multiple sclerosis . Fingolimod . NEDA-3 . Annualized relapse rate Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10072-020-04380-y) contains supplementary material, which is available to authorized users. * Delia Colombo [email protected] 1
San Raffaele Hospital, Milan, Italy
2
Department of Human Neuroscience, Sapienza University, Rome, Italy
3
Multiple Sclerosis Center, S. Andrea Hospital, Rome, Italy
4
Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, Naples, Italy
5
A.O.U. San Luigi Gonzaga, Orbassano, Turin, Italy
6
Department of Neurosciences, S. Camillo-Forlanini Hospital, Rome, Italy
7
Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy
8
Novartis Farma S.p.A, Origgio, VA, Italy
9
MediNeos Observational Research, Modena, Italy
Introduction Fingolimod (FNG), proven efficacious in three large phase III trials [1–3] and in their extensions [4, 5], is a widely used oral medication licensed in the USA for the first-line treatment of relapsing-remitting form of multiple s
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