Comparison of multiple sclerosis patients with or without rebound activity after fingolimod cessation: Five-year clinical outcomes

Eur J Neurol. 2023 Sep;30(9):2745-2751. doi: 10.1111/ene.15913. Epub 2023 Jun 23.

Abstract

Background: Patients with multiple sclerosis (MS) who discontinue fingolimod might present with rebound activity. The reasons for the development of rebound have been identified, but there are limited data on the long-term clinical outcomes of these patients. This study aimed to compare the long-term outcomes of patients with MS with and without rebound activity after fingolimod discontinuation.

Methods: A total of 31 patients who discontinued fingolimod for various reasons with a minimum follow-up of 5 years were included in the study. Of these, 10 were assigned to the rebound group and 21 to the non-rebound group. Clinical and demographic data and 5-year clinical outcomes of both groups were prospectively examined.

Results: At fingolimod initiation, there were no significant differences in age, disease duration, and Expanded Disability Status Scale (EDSS) score. The annualized relapse rate (ARR) was significantly higher in the rebound group than in the non-rebound group before the fingolimod treatment (p = 0.005). In the rebound group, EDSS scores 2 months after rebound treatment and at the 5-year follow-up were not significantly different than before fingolimod initiation (p = 0.14 and p = 0.46, respectively). The last recorded EDSS was significantly higher in the non-rebound group than in the rebound group (3.6 ± 2.3 vs. 2.15 ± 1.4, p = 0.045). At the last follow-up, one patient was diagnosed with secondary progressive multiple sclerosis in the rebound group (10%), and 11 patients were in the non-rebound group (52.4%, p = 0.05).

Conclusion: When rebound activity is well-monitored and treated after fingolimod discontinuation, no overall EDSS change is expected in the long-term follow-up.

Keywords: annualized relapse rate; clinical outcome; fingolimod cessation; fingolimod rebound; multiple sclerosis.

MeSH terms

  • Fingolimod Hydrochloride / therapeutic use
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Multiple Sclerosis* / drug therapy
  • Multiple Sclerosis, Chronic Progressive* / drug therapy
  • Multiple Sclerosis, Relapsing-Remitting* / drug therapy
  • Recurrence

Substances

  • Fingolimod Hydrochloride
  • Immunosuppressive Agents