A decade of fingolimod in multiple sclerosis: Insights from a large real-world cohort study - 13/06/23
, K. Bigaut a, b, c, É. Berger d, M. Debouverie e, T. Moreau f, J. de Sèze a, b, cHighlights |
• | Annualized relapse rate stays low after several years of fingolimod treatment. |
• | Relapse risk depends on the number of relapses preceding fingolimod initiation, baseline EDSS, sex, age and the number or types of previous treatments. |
• | Disability risk is only influenced by sex. |
• | Sex, annualized relapse rate or disease duration at baseline were not associated with persistence or discontinuation of fingolimod. |
Abstract |
Background and objectives |
Ten years after its authorization, data about fingolimod use in real-world setting is still scarce. Here we describe the long-term evolution of fingolimod-treated relapsing-remitting MS (RRMS) patients and determine baseline characteristics associated with risk of relapses or disability.
Methods |
We analyzed baseline characteristics and clinical evolution of 1227 patients with RRMS treated with fingolimod from 2010 to 2019 in 4 French MS referral centers. We used Cox models to determine risks factors of relapses and sustained EDSS worsening.
Results |
Median follow-up duration was 50 months, and 63% of patients remained fingolimod-treated at the end of follow-up. Mean 5-years annualized relapse rate (ARR) decreased from 0.63 (0.60–0.67) to 0.26 (0.24–0.29, P<0.001), while the mean EDSS rose from 2.5 (2.4–2.6) to 3.0 (2.8–3.1, P<0.001). Female sex, lower age, higher EDSS and use of natalizumab were associated with relapse risk. Female sex was associated with sustained EDSS increase risk.
Conclusions |
Based on a large real-world cohort, our results confirm the durable reduction of the ARR described in pivot studies. Switching from moderate-efficacy DMT to fingolimod decreased the relapse risk. Switching patients from high-efficacy DMT increased risk of relapse, but the overall five-years ARR remained stable.
Le texte complet de cet article est disponible en PDF.Keywords : Multiple sclerosis, Relapsing remitting, Fingolimod, Follow-up studies, Risk factors, Treatment outcome, France
Plan
Vol 179 - N° 6
P. 576-584 - juin 2023 Retour au numéro
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