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An observational comparison of natalizumab vs. fingolimod using JCV serology to determine therapy.
Mult Scler 2014; 20(10):1381-90MS

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.

Authors+Show Affiliations

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

Pub Type(s)

Comparative Study
Journal Article
Observational Study

Language

eng

PubMed ID

24852928

Citation

Carruthers, Robert L., et al. "An Observational Comparison of Natalizumab Vs. Fingolimod Using JCV Serology to Determine Therapy." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 20, no. 10, 2014, pp. 1381-90.
Carruthers RL, Rotstein DL, Healy BC, et al. An observational comparison of natalizumab vs. fingolimod using JCV serology to determine therapy. Mult Scler. 2014;20(10):1381-90.
Carruthers, R. L., Rotstein, D. L., Healy, B. C., Chitnis, T., Weiner, H. L., & Buckle, G. J. (2014). An observational comparison of natalizumab vs. fingolimod using JCV serology to determine therapy. Multiple Sclerosis (Houndmills, Basingstoke, England), 20(10), pp. 1381-90. doi:10.1177/1352458514535282.
Carruthers RL, et al. An Observational Comparison of Natalizumab Vs. Fingolimod Using JCV Serology to Determine Therapy. Mult Scler. 2014;20(10):1381-90. PubMed PMID: 24852928.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An observational comparison of natalizumab vs. fingolimod using JCV serology to determine therapy. AU - Carruthers,Robert L, AU - Rotstein,Dalia L, AU - Healy,Brian C, AU - Chitnis,Tanuja, AU - Weiner,Howard L, AU - Buckle,Guy J, Y1 - 2014/05/22/ PY - 2014/5/24/entrez PY - 2014/5/24/pubmed PY - 2015/10/28/medline KW - JCV serology KW - Natalizumab KW - fingolimod KW - observational data SP - 1381 EP - 90 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult. Scler. VL - 20 IS - 10 N2 - 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. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/24852928/An_observational_comparison_of_natalizumab_vs__fingolimod_using_JCV_serology_to_determine_therapy_ L2 - http://journals.sagepub.com/doi/full/10.1177/1352458514535282?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -