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

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

Author information

1
Harvard Medical School, USA/Partners Multiple Sclerosis Center, Brigham and Women's Hospital, USA.
2
Harvard Medical School, USA/Partners Multiple Sclerosis Center, Brigham and Women's Hospital, USA/Biostatistics Center, Massachusetts General Hospital, USA.
3
Harvard Medical School, USA/Partners Multiple Sclerosis Center, Brigham and Women's Hospital, USA gbuckle@partners.org.

Abstract

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

PMID:
24852928
DOI:
10.1177/1352458514535282
[Indexed for MEDLINE]

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