Comparative analysis of first-year fingolimod and natalizumab drug discontinuation among Swedish patients with multiple sclerosis

Mult Scler. 2016 Jan;22(1):85-93. doi: 10.1177/1352458515579216. Epub 2015 Apr 28.


Background: Natalizumab (NTZ) and fingolimod (FGL) are mainly used second line in relapsing-remitting multiple sclerosis (MS), although pivotal trials included mainly treatment-naïve patients.

Objective: This study aims to provide real-world data on safety and discontinuation rates.

Methods: Using IMSE, a drug monitoring registry for all newer MS drugs in Sweden, we analysed differences in baseline characteristics and 1-year drug survival for patients registered 2011-2013, initiating treatment with NTZ (n=640) or FGL (n=876). Among FGL initiators, n=383 (44%) had previously used NTZ (FGL(afterNTZ)).

Results: Compared with NTZ, the FGL cohort was older and more often male (36/38 years, 24%/33% males). Baseline Expanded Disability Status Scale was similar across groups, but MS Severity Score was higher in NTZ patients, and Symbol Digit Modalities Test and MS Impact Scale (MSIS-29) was higher in FGL(afterNTZ) versus FGL(NTZ-naïve) patients. Proportion on drug after 1 year was high, NTZ=87%, FGL(NTZ-naïve)=83% and FGL(afterNTZ)=76%. Adverse events was the most frequent reason for discontinuing FGL (FGL(NTZ-naïve)=9%, FGL(afterNTZ)=12%), and was significantly higher than on NTZ (3%). In contrast, the proportion of patients stopping treatment due to lack of effect was more similar: NTZ=4%, FGL(NTZ-naïve)=3%, FGL(afterNTZ)=8%.

Conclusion: FGL and NTZ were both well tolerated, but FGL less so than NTZ, especially in patients switching to FGL from NTZ. Group differences were not explained by differences in recorded baseline characteristics.

Keywords: Multiple sclerosis; drug survival; fingolimod; health services research; natalizumab; treatment outcome.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Fingolimod Hydrochloride / adverse effects
  • Fingolimod Hydrochloride / therapeutic use*
  • Humans
  • Immunologic Factors / adverse effects
  • Immunologic Factors / therapeutic use*
  • Male
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Natalizumab / adverse effects
  • Natalizumab / therapeutic use*
  • Registries*
  • Severity of Illness Index
  • Sex Factors
  • Sweden
  • Time Factors
  • Treatment Outcome


  • Immunologic Factors
  • Natalizumab
  • Fingolimod Hydrochloride