The impact of very short transition times on switching from Natalizumab to Fingolimod on imaging and clinical effectiveness outcomes in multiple sclerosis

J Neurol Sci. 2018 Jul 15;390:89-93. doi: 10.1016/j.jns.2018.04.021. Epub 2018 Apr 13.

Abstract

Background: Due to the recurrence of disease activity in multiple sclerosis (MS) patients, a washout period of <3 months has been suggested for the transition from natalizumab (NTZ) to fingolimod (FTY). However, very short transition periods of <1 month may be more beneficial.

Methods: Retrospective analysis of patients from the Rocky Mountain MS Center at the University of Colorado who were: a) on NTZ for ≥6 months prior to switching to FTY; b) had a transition period ≤ 6 months; and c) initiated FTY treatment prior to November 2013. Transition periods were grouped as follows: <1 month, 1-2 months, and 3-6 months. Outcomes assessed include clinical and MRI measures within one year of FTY initiation.

Results: Thirty-seven, 56 and 24 patients had a transition period < 1 month, 1-2 months and 3-6 months, respectively. Baseline characteristics were well matched: mean age 45-49 years (p = 0.17), disease duration 11-13 years (p = 0.42), and ~70% women (p = 1.00). Following the switch (including transition period), clinical relapses were observed in 0% (<1 month), 12.5% (1-2 months), 37.5% (3-6 month) (p < 0.001) of patients. New gadolinium enhancing lesions occurred in 3.3% (<1 month), 13% (1-2 months), 21.4% (3-6 months) (p = 0.13) patients. New T2 lesions were observed in 11.1% (<1 month), 16.3% (1-2 months), 33.3% (3-6 months) (p = 0.28) of patients. There were no unexpected adverse events or PML observed.

Conclusions: Minimizing transition times from NTZ to FTY was beneficial and safe.

Keywords: Disease modifying therapy; Drug sequencing; Gilenya; Tysabri; Washout period.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Contrast Media
  • Drug Administration Schedule
  • Female
  • Fingolimod Hydrochloride / administration & dosage*
  • Gadolinium
  • Humans
  • Immunologic Factors / administration & dosage*
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Multiple Sclerosis / diagnostic imaging*
  • Multiple Sclerosis / drug therapy*
  • Natalizumab / administration & dosage*
  • Retrospective Studies
  • Survival Analysis
  • Time Factors
  • Treatment Outcome

Substances

  • Contrast Media
  • Immunologic Factors
  • Natalizumab
  • Gadolinium
  • Fingolimod Hydrochloride