Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients

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2017
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Heesen, Christoph
Kleiter, Ingo
Meuth, Sven G.
Krämer, Julia
Kasper, Jürgen
Köpke, Sascha
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Zusammenfassung

Background

Natalizumab (NAT) is associated with the risk of progressive multifocal leukoencephalopathy (PML). Risk stratification algorithms have been developed, however, without detectable reduction of PML incidence.

Objective

To evaluate to which extent patients and physicians understand and accept risks associated with NAT treatment.

Methods

Prospective observational cohort study in German MS centers (n = 73) among NAT-treated MS patients (n = 801) and their neurologists (n = 99). Patients included in this study had mean disease duration of 10.2 years and a mean NAT treatment duration of 24 months.

Results

More than 90% of patients and physicians voted for shared decision making or an informed choice decision making approach. Patients and physicians perceived a similar threat from MS as serious disease and both overestimated treatment benefits from NAT based on trial data. Men perceived MS more severe than women and perception of seriousness increased with age in both groups and in patients as well with increasing disability. Although patients evaluated their PML risk higher, their risk acceptance was significantly higher than of their neurologists. Risk stratification knowledge was good among neurologists and significantly lower among patients.

Conclusion

While patients and physicians seem to have realistic risk perception of PML and knowledge of risk stratification concepts, the threat of MS and the perception of treatment benefits may explain the ongoing high acceptance of PML risk.

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Fachgebiet (DDC)
150 Psychologie
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Multiple sclerosis, Natalizumab, Progressive multifocal leukoencephalopathy, Risk perception, Risk attribution, Risk knowledge, Shared decision making
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ISO 690HEESEN, Christoph, Ingo KLEITER, Sven G. MEUTH, Julia KRÄMER, Jürgen KASPER, Sascha KÖPKE, Wolfgang GAISSMAIER, 2017. Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients. In: Journal of the Neurological Sciences. 2017, 376, pp. 181-190. ISSN 0022-510X. eISSN 1878-5883. Available under: doi: 10.1016/j.jns.2017.03.001
BibTex
@article{Heesen2017-03Benef-38190,
  year={2017},
  doi={10.1016/j.jns.2017.03.001},
  title={Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients},
  volume={376},
  issn={0022-510X},
  journal={Journal of the Neurological Sciences},
  pages={181--190},
  author={Heesen, Christoph and Kleiter, Ingo and Meuth, Sven G. and Krämer, Julia and Kasper, Jürgen and Köpke, Sascha and Gaissmaier, Wolfgang}
}
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    <dcterms:abstract xml:lang="eng">Background&lt;br /&gt;&lt;br /&gt;Natalizumab (NAT) is associated with the risk of progressive multifocal leukoencephalopathy (PML). Risk stratification algorithms have been developed, however, without detectable reduction of PML incidence.&lt;br /&gt;&lt;br /&gt;Objective&lt;br /&gt;&lt;br /&gt;To evaluate to which extent patients and physicians understand and accept risks associated with NAT treatment.&lt;br /&gt;&lt;br /&gt;Methods&lt;br /&gt;&lt;br /&gt;Prospective observational cohort study in German MS centers (n = 73) among NAT-treated MS patients (n = 801) and their neurologists (n = 99). Patients included in this study had mean disease duration of 10.2 years and a mean NAT treatment duration of 24 months.&lt;br /&gt;&lt;br /&gt;Results&lt;br /&gt;&lt;br /&gt;More than 90% of patients and physicians voted for shared decision making or an informed choice decision making approach. Patients and physicians perceived a similar threat from MS as serious disease and both overestimated treatment benefits from NAT based on trial data. Men perceived MS more severe than women and perception of seriousness increased with age in both groups and in patients as well with increasing disability. Although patients evaluated their PML risk higher, their risk acceptance was significantly higher than of their neurologists. Risk stratification knowledge was good among neurologists and significantly lower among patients.&lt;br /&gt;&lt;br /&gt;Conclusion&lt;br /&gt;&lt;br /&gt;While patients and physicians seem to have realistic risk perception of PML and knowledge of risk stratification concepts, the threat of MS and the perception of treatment benefits may explain the ongoing high acceptance of PML risk.</dcterms:abstract>
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