Retrospectively acquired cohort study to evaluate the long-term impact of two different treatment strategies on disability outcomes in patients with relapsing multiple sclerosis (RE.LO.DI.MS): data from the Italian MS Register

J Neurol. 2019 Dec;266(12):3098-3107. doi: 10.1007/s00415-019-09531-6. Epub 2019 Sep 18.


Background: The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies.

Objective: To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS 'real-world' settings.

Methods: Multicentre, observational, retrospectively acquired cohort study evaluating the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register.

Results: We evaluated 1152 RMS-naïve patients after propensity-score adjustment. Patients included were receiving: interferon beta-1a (IFN-β1a) 44 µg switching to fingolimod (FTY; IFN-switchers; n = 97); FTY only (FTY-stayers; n = 157); IFN-β1a only (IFN-stayers; n = 849). CDP and relapses did not differ between FTY-stayers and IFN-switchers [HR (95% CI) 0.99 (0.48-2.04), p = 0.98 and 0.81 (0.42-1.58), p = 0.55, respectively]. However, IFN-stayers showed increased risk of relapses compared with FTY-stayers [HR (95% CI) 1.46 (1.00-2.12), p = 0.05].

Conclusion: The ideal treatment option for MS is becoming increasingly complex, with the need to balance benefit and risks. Our results suggest that starting with FTY affects the long-term disease outcome similarly to escalating from IFN-β1a to FTY.

Keywords: EDSS score; Interferons; Long-term outcomes; Multiple sclerosis; Real-world setting; Treatment sequences.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Disease Progression*
  • Drug Administration Schedule
  • Female
  • Fingolimod Hydrochloride / administration & dosage
  • Fingolimod Hydrochloride / pharmacology*
  • Humans
  • Immunologic Factors / administration & dosage
  • Immunologic Factors / pharmacology*
  • Interferon beta-1a / administration & dosage
  • Interferon beta-1a / pharmacology*
  • Italy
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / physiopathology*
  • Outcome Assessment, Health Care*
  • Registries*
  • Retrospective Studies
  • Severity of Illness Index*


  • Immunologic Factors
  • Fingolimod Hydrochloride
  • Interferon beta-1a