A decade of fingolimod in multiple sclerosis: Insights from a large real-world cohort study

Rev Neurol (Paris). 2023 Jun;179(6):576-584. doi: 10.1016/j.neurol.2022.11.012. Epub 2023 Feb 24.

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.

Keywords: Fingolimod; Follow-up studies; France; Multiple sclerosis; Relapsing remitting; Risk factors; Treatment outcome.

MeSH terms

  • Cohort Studies
  • Female
  • Fingolimod Hydrochloride / therapeutic use
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Multiple Sclerosis* / drug therapy
  • Multiple Sclerosis* / epidemiology
  • Multiple Sclerosis, Relapsing-Remitting* / drug therapy
  • Multiple Sclerosis, Relapsing-Remitting* / epidemiology
  • Natalizumab / adverse effects
  • Recurrence

Substances

  • Fingolimod Hydrochloride
  • Natalizumab
  • Immunosuppressive Agents