Abstract | BACKGROUND: OBJECTIVES: The aim of this analysis was to evaluate the net benefits and risks for patients with RRMS receiving natalizumab treatment compared with fingolimod, interferon-β, and no treatment across PML risk sub-groups. RESEARCH DESIGN AND METHODS: Based on previously validated MS model structures, a Markov cohort model was developed to assess the impact of treatment on quality-adjusted life years (QALYs). Natalizumab-treated patients were classified by PML risk sub-groups and analysed separately for short-term (2 years) and long-term (20 years) time horizons. MAIN OUTCOME MEASURES: Main outcome measures included total QALYs by PML risk sub-group and the increase in PML risk associated with natalizumab treatment which offsets the quality of life benefit of comparator treatments. RESULTS: Results showed higher QALYs with natalizumab versus all other comparators across PML risk sub-groups over both time horizons. For the QALYs of natalizumab to equal the QALYs of fingolimod, interferon-β, and no treatment, the risk of PML would have to increase 4.6-84.2 times, 24.0-444.3 times, and 5.7-106.1 times, respectively (short term), and 1.4-123.4 times, 1.5-138.3 times, and 2.2-193.7 times, respectively (long term). CONCLUSION: This study shows that natalizumab generates the most net health benefits in terms of quality-adjusted life years compared with fingolimod, interferon-β, or no treatment, even when the risk of natalizumab-associated PML is taken into consideration. This study is limited by the availability of published data around natalizumab-associated PML, as well as the constraints of the model used to conduct the analysis.
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Authors | Anna Walker, Crystal Watson, Stamatia T Alexopoulos, Baris Deniz, Ryan Arnold, David Bates |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 30
Issue 4
Pg. 629-35
(Apr 2014)
ISSN: 1473-4877 [Electronic] England |
PMID | 24289170
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal, Humanized
- Natalizumab
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Topics |
- Antibodies, Monoclonal, Humanized
(adverse effects)
- Humans
- Leukoencephalopathy, Progressive Multifocal
(chemically induced)
- Multiple Sclerosis, Relapsing-Remitting
(drug therapy)
- Natalizumab
- Quality-Adjusted Life Years
- Risk
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