An observational comparison of natalizumab vs. fingolimod using JCV serology to determine therapy

Mult Scler. 2014 Sep;20(10):1381-90. doi: 10.1177/1352458514535282. Epub 2014 May 22.


Background: The lack of prospective trial data comparing certain multiple sclerosis (MS) therapies could be addressed with observational research.

Objective: The objective of this paper is to investigate outcomes of natalizumab versus fingolimod treatment in an MS cohort using a novel method of patient selection.

Methods: We reviewed entries from our clinic's database for all relapsing-remitting MS patients started on fingolimod and natalizumab where JCV serology was used to determine treatment. We analyzed each group for time to first relapse and in a second analysis, time to first relapse or gadolinium-enhancing lesion.

Results: Sixty-nine patients on natalizumab and 36 on fingolimod met our inclusion criteria and had adequate follow-up for analysis. The baseline clinical characteristics at the time of treatment switch were similar. With a mean follow-up of 1.5 years for both treatment groups, there was a trend favoring natalizumab in time to first relapse, although this was not statistically significant (2.20 (0.87, 5.55) p = 0.095). There was a significant difference in the secondary outcome, time to relapse or gadolinium-enhancing lesion (2.31 (1.03, 5.17) p = 0.041), favoring natalizumab. Adjusted analyses favored natalizumab for both outcomes (p < 0.05).

Conclusion: This work employed an observational study design where treatment allocation by JCV serology allowed for treatment groups with well-balanced characteristics.

Keywords: JCV serology; Natalizumab; fingolimod; observational data.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Antibodies, Viral / blood*
  • Biomarkers / blood
  • Contrast Media
  • Databases, Factual
  • Disease-Free Survival
  • Female
  • Fingolimod Hydrochloride
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • JC Virus / immunology*
  • Kaplan-Meier Estimate
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / blood
  • Multiple Sclerosis, Relapsing-Remitting / diagnosis
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / immunology
  • Multiple Sclerosis, Relapsing-Remitting / virology
  • Natalizumab
  • Predictive Value of Tests
  • Propylene Glycols / therapeutic use*
  • Retrospective Studies
  • Serologic Tests*
  • Sphingosine / analogs & derivatives*
  • Sphingosine / therapeutic use
  • Time Factors
  • Treatment Outcome


  • Antibodies, Monoclonal, Humanized
  • Antibodies, Viral
  • Biomarkers
  • Contrast Media
  • Immunosuppressive Agents
  • Natalizumab
  • Propylene Glycols
  • Fingolimod Hydrochloride
  • Sphingosine