Abstract:
BACKGROUND:Natalizumab is a highly effective treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Treatment with natalizumab has been associated with progressive multifocal leukoencephalopathy (PML), a rare yet serious disease of the brain. Published studies have quantified the PML risk by the presence of anti-JC virus antibodies, previous immunosuppressant use, and duration of natalizumab treatment. 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.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Walker A,Watson C,Alexopoulos ST,Deniz B,Arnold R,Bates Ddoi
10.1185/03007995.2013.869492subject
Has Abstractpub_date
2014-04-01 00:00:00pages
629-35issue
4eissn
0300-7995issn
1473-4877journal_volume
30pub_type
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journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2012.695731
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journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Current medical research and opinion
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journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
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journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
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doi:10.1185/03007995.2016.1168291
更新日期:2016-07-01 00:00:00
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journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
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abstract:INTRODUCTION:Phenylketonuria (PKU) is a rare autosomal recessive disorder caused by a deficiency of phenylalanine hydroxylase (PAH). Its prevalence is estimated to be 1:10,000 in Europe. PKU is the commonest congenital inborn error of metabolism. The aim of our study was to investigate the characteristics of clinical p...
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journal_title:Current medical research and opinion
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doi:
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pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2011-02-01 00:00:00