Robert L Carruthers1, Dalia L Rotstein1, Brian C Healy2, Tanuja Chitnis1, Howard L Weiner1, Guy J Buckle3. 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.
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 MSpatients 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.
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