A longitudinal real-life comparison study of natalizumab and fingolimod

Acta Neurol Scand. 2017 Sep;136(3):217-222. doi: 10.1111/ane.12718. Epub 2016 Dec 15.

Abstract

Background: Different retrospective studies compared natalizumab and fingolimod in relapsing-remitting multiple sclerosis (RRMS), with conflicting results. We aimed to explore the prescriptive attitude and the clinical outcome of the two therapies.

Methods: We retrospectively included all RRMS patients treated with natalizumab (n=101) or fingolimod (n=78) as their first second-line therapy with at least 24-month follow-up. Demographic and clinical features were recorded to calculate the propensity score (PS). Outcomes of interest were annualized relapse rate (ARR), risk of relapse, and change in the EDSS RESULTS: At baseline, natalizumab patients were younger and had a shorter disease duration, a higher number of relapse in 1 year (1yR) and 2 years (2yR) and overall (ARR-PT) pretherapy, compared to fingolimod patients. On therapy, the proportion of relapsing patients and the mean RR were similar in the two groups. However, the change in the ARR was higher in natalizumab than in fingolimod group (P<.002), but, using PS as a covariate, it was comparable (P=.960). Similarly, the change in EDSS was significantly different for the two groups (P<.004), but not after adjusting for the PS (P=.321).

Conclusion: We observed a comparable efficacy on ARR reduction and on EDSS progression with natalizumab and fingolimod correcting through PS, suggesting that the efficacy difference observed before correction might derive from the clinical attitude in prescribing natalizumab in more active MS patients in real life.

Keywords: DMT; fingolimod; multiple sclerosis; natalizumab; propensity score.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Female
  • Fingolimod Hydrochloride / administration & dosage
  • Fingolimod Hydrochloride / adverse effects
  • Fingolimod Hydrochloride / therapeutic use*
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Natalizumab / administration & dosage
  • Natalizumab / adverse effects
  • Natalizumab / therapeutic use*
  • Retrospective Studies

Substances

  • Immunosuppressive Agents
  • Natalizumab
  • Fingolimod Hydrochloride