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Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study
Health-related quality of life (HRQoL) is impaired in multiple sclerosis (MS) but can be improved by disease-modifying therapies such as natalizumab. However, the predictive factors and neuropsychiatric correlates of HRQoL improvement are unknown. In this study, 48 patients with relapsing-remitting...
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| Published in: | Journal of the neurological sciences 2017-11, Vol.382, p.148-154 |
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| container_title | Journal of the neurological sciences |
| container_volume | 382 |
| creator | Planche, Vincent Moisset, Xavier Morello, Remy Dumont, Emilie Gibelin, Marion Charré-Morin, Julie Saubusse, Aurore Mondou, Audrey Reuter, Françoise Defer, Gilles Pelletier, Jean Brochet, Bruno Clavelou, Pierre |
| description | Health-related quality of life (HRQoL) is impaired in multiple sclerosis (MS) but can be improved by disease-modifying therapies such as natalizumab. However, the predictive factors and neuropsychiatric correlates of HRQoL improvement are unknown.
In this study, 48 patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the disease-specific MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6months, 12months, 18months and 36months after starting natalizumab therapy.
Compared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6months after the beginning of natalizumab therapy, with medium effect-size (58.6±16.2 vs 69.8±18.9, p |
| doi_str_mv | 10.1016/j.jns.2017.10.008 |
| format | article |
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In this study, 48 patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the disease-specific MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6months, 12months, 18months and 36months after starting natalizumab therapy.
Compared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6months after the beginning of natalizumab therapy, with medium effect-size (58.6±16.2 vs 69.8±18.9, p<0.001, Cohen's d=0.63). This improvement was maintained over time for up to 3years and mainly concerned activity of daily living, psychological well-being, symptoms and coping (p<0.001 for every dimensions). The variation of global HRQoL after 3years was negatively correlated with the variation of fatigue score (r=−0.44, p=0.015). Furthermore, a higher fatigue score at baseline was correlated with improvement in global HRQoL 3years afterwards (r=0.34, p=0.041), independently of age, educational level, disease duration and disability at baseline (β=2.45, p=0.020). Disability at baseline, cognitive impairment, anxiety and depression failed to predict or correlate with global HRQoL improvement in multivariate analyses.
Natalizumab improved HRQoL quickly and sustainably in patients with relapsing-remitting MS. In terms of HRQoL, natalizumab seems to benefit mostly patients with more marked fatigue at baseline.
•Natalizumab significantly increased HRQoL 6months after the beginning of treatment.•This improvement is maintained over time for up to 3years.•The variation of HRQoL is negatively correlated with the variation of fatigue.•Higher fatigue score at baseline is independently correlated with improvement in HRQoL 3years afterwards.</description><identifier>ISSN: 0022-510X</identifier><identifier>EISSN: 1878-5883</identifier><identifier>DOI: 10.1016/j.jns.2017.10.008</identifier><identifier>PMID: 29111011</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adult ; Cognition ; Depression ; Disability Evaluation ; Disease Progression ; Fatigue ; Fatigue - drug therapy ; Fatigue - physiopathology ; Fatigue - psychology ; Female ; Follow-Up Studies ; Health-related quality of life ; Humans ; Immunologic Factors - therapeutic use ; Life Sciences ; Male ; Multiple sclerosis ; Multiple Sclerosis, Relapsing-Remitting - drug therapy ; Multiple Sclerosis, Relapsing-Remitting - physiopathology ; Multiple Sclerosis, Relapsing-Remitting - psychology ; Natalizumab ; Natalizumab - therapeutic use ; Neurons and Cognition ; Neuropsychological Tests ; Quality of Life ; Treatment Outcome</subject><ispartof>Journal of the neurological sciences, 2017-11, Vol.382, p.148-154</ispartof><rights>2017 Elsevier B.V.</rights><rights>Copyright © 2017 Elsevier B.V. All rights reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c387t-7306f33417de0dd5705f91ca502514c6f4b9fa85ac78014b3dfa345be02c0eae3</citedby><cites>FETCH-LOGICAL-c387t-7306f33417de0dd5705f91ca502514c6f4b9fa85ac78014b3dfa345be02c0eae3</cites><orcidid>0000-0003-3713-227X ; 0000-0001-9730-7567 ; 0000-0003-3824-2796 ; 0000-0002-8799-0750</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29111011$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://uca.hal.science/hal-01680874$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Planche, Vincent</creatorcontrib><creatorcontrib>Moisset, Xavier</creatorcontrib><creatorcontrib>Morello, Remy</creatorcontrib><creatorcontrib>Dumont, Emilie</creatorcontrib><creatorcontrib>Gibelin, Marion</creatorcontrib><creatorcontrib>Charré-Morin, Julie</creatorcontrib><creatorcontrib>Saubusse, Aurore</creatorcontrib><creatorcontrib>Mondou, Audrey</creatorcontrib><creatorcontrib>Reuter, Françoise</creatorcontrib><creatorcontrib>Defer, Gilles</creatorcontrib><creatorcontrib>Pelletier, Jean</creatorcontrib><creatorcontrib>Brochet, Bruno</creatorcontrib><creatorcontrib>Clavelou, Pierre</creatorcontrib><title>Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study</title><title>Journal of the neurological sciences</title><addtitle>J Neurol Sci</addtitle><description>Health-related quality of life (HRQoL) is impaired in multiple sclerosis (MS) but can be improved by disease-modifying therapies such as natalizumab. However, the predictive factors and neuropsychiatric correlates of HRQoL improvement are unknown.
In this study, 48 patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the disease-specific MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6months, 12months, 18months and 36months after starting natalizumab therapy.
Compared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6months after the beginning of natalizumab therapy, with medium effect-size (58.6±16.2 vs 69.8±18.9, p<0.001, Cohen's d=0.63). This improvement was maintained over time for up to 3years and mainly concerned activity of daily living, psychological well-being, symptoms and coping (p<0.001 for every dimensions). The variation of global HRQoL after 3years was negatively correlated with the variation of fatigue score (r=−0.44, p=0.015). Furthermore, a higher fatigue score at baseline was correlated with improvement in global HRQoL 3years afterwards (r=0.34, p=0.041), independently of age, educational level, disease duration and disability at baseline (β=2.45, p=0.020). Disability at baseline, cognitive impairment, anxiety and depression failed to predict or correlate with global HRQoL improvement in multivariate analyses.
Natalizumab improved HRQoL quickly and sustainably in patients with relapsing-remitting MS. In terms of HRQoL, natalizumab seems to benefit mostly patients with more marked fatigue at baseline.
•Natalizumab significantly increased HRQoL 6months after the beginning of treatment.•This improvement is maintained over time for up to 3years.•The variation of HRQoL is negatively correlated with the variation of fatigue.•Higher fatigue score at baseline is independently correlated with improvement in HRQoL 3years afterwards.</description><subject>Adult</subject><subject>Cognition</subject><subject>Depression</subject><subject>Disability Evaluation</subject><subject>Disease Progression</subject><subject>Fatigue</subject><subject>Fatigue - drug therapy</subject><subject>Fatigue - physiopathology</subject><subject>Fatigue - psychology</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Health-related quality of life</subject><subject>Humans</subject><subject>Immunologic Factors - therapeutic use</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Multiple sclerosis</subject><subject>Multiple Sclerosis, Relapsing-Remitting - drug therapy</subject><subject>Multiple Sclerosis, Relapsing-Remitting - physiopathology</subject><subject>Multiple Sclerosis, Relapsing-Remitting - psychology</subject><subject>Natalizumab</subject><subject>Natalizumab - therapeutic use</subject><subject>Neurons and Cognition</subject><subject>Neuropsychological Tests</subject><subject>Quality of Life</subject><subject>Treatment Outcome</subject><issn>0022-510X</issn><issn>1878-5883</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp9kU1v1DAQhi0EotvCD-CCfIRDlnE-vXBaVUArrcQFJG6W40xYr5w49cdW4d_xz3Ca0iMn26NnnrHmJeQNgy0DVn84bU-j3-bAmvTeAvBnZMN4w7OK8-I52QDkeVYx-HlBLr0_AUDN-e4luch3jCUD25A_t8Pk7BkHHAO1Pb2L0ugwL1eje6Ry7KgOnjo0Mmg7-qOe6L0ORzpidHbyszpqGZxW1Mag7ICe6pFOCU5Gv6JDNEFPBqlXBp312lMfpAt6_EWDQxkepq9WGdIHfsdBth_pnhbZjNLR3hpj77M4rSqV8GWiD7GbX5EXvTQeXz-eV-THl8_fr2-yw7evt9f7Q6YK3oSsKaDui6JkTYfQdVUDVb9jSlaQV6xUdV-2u17ySqqGAyvboutlUVYtQq4AJRZX5P3qPUojJqcH6WZhpRY3-4NYaikRDrwpzyyx71Y27fYuog9i0F6hMXJEG71gu5rVZV3kkFC2oiotxjvsn9wMxJKyOImUslhSXkop5dTz9lEf2wG7p45_sSbg0wpgWshZoxNepTwUdtqhCqKz-j_6vw9rvYk</recordid><startdate>20171115</startdate><enddate>20171115</enddate><creator>Planche, Vincent</creator><creator>Moisset, Xavier</creator><creator>Morello, Remy</creator><creator>Dumont, Emilie</creator><creator>Gibelin, Marion</creator><creator>Charré-Morin, Julie</creator><creator>Saubusse, Aurore</creator><creator>Mondou, Audrey</creator><creator>Reuter, Françoise</creator><creator>Defer, Gilles</creator><creator>Pelletier, Jean</creator><creator>Brochet, Bruno</creator><creator>Clavelou, Pierre</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0003-3713-227X</orcidid><orcidid>https://orcid.org/0000-0001-9730-7567</orcidid><orcidid>https://orcid.org/0000-0003-3824-2796</orcidid><orcidid>https://orcid.org/0000-0002-8799-0750</orcidid></search><sort><creationdate>20171115</creationdate><title>Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study</title><author>Planche, Vincent ; Moisset, Xavier ; Morello, Remy ; Dumont, Emilie ; Gibelin, Marion ; Charré-Morin, Julie ; Saubusse, Aurore ; Mondou, Audrey ; Reuter, Françoise ; Defer, Gilles ; Pelletier, Jean ; Brochet, Bruno ; Clavelou, Pierre</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c387t-7306f33417de0dd5705f91ca502514c6f4b9fa85ac78014b3dfa345be02c0eae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Cognition</topic><topic>Depression</topic><topic>Disability Evaluation</topic><topic>Disease Progression</topic><topic>Fatigue</topic><topic>Fatigue - drug therapy</topic><topic>Fatigue - physiopathology</topic><topic>Fatigue - psychology</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Health-related quality of life</topic><topic>Humans</topic><topic>Immunologic Factors - therapeutic use</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Multiple sclerosis</topic><topic>Multiple Sclerosis, Relapsing-Remitting - drug therapy</topic><topic>Multiple Sclerosis, Relapsing-Remitting - physiopathology</topic><topic>Multiple Sclerosis, Relapsing-Remitting - psychology</topic><topic>Natalizumab</topic><topic>Natalizumab - therapeutic use</topic><topic>Neurons and Cognition</topic><topic>Neuropsychological Tests</topic><topic>Quality of Life</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Planche, Vincent</creatorcontrib><creatorcontrib>Moisset, Xavier</creatorcontrib><creatorcontrib>Morello, Remy</creatorcontrib><creatorcontrib>Dumont, Emilie</creatorcontrib><creatorcontrib>Gibelin, Marion</creatorcontrib><creatorcontrib>Charré-Morin, Julie</creatorcontrib><creatorcontrib>Saubusse, Aurore</creatorcontrib><creatorcontrib>Mondou, Audrey</creatorcontrib><creatorcontrib>Reuter, Françoise</creatorcontrib><creatorcontrib>Defer, Gilles</creatorcontrib><creatorcontrib>Pelletier, Jean</creatorcontrib><creatorcontrib>Brochet, Bruno</creatorcontrib><creatorcontrib>Clavelou, Pierre</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Journal of the neurological sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Planche, Vincent</au><au>Moisset, Xavier</au><au>Morello, Remy</au><au>Dumont, Emilie</au><au>Gibelin, Marion</au><au>Charré-Morin, Julie</au><au>Saubusse, Aurore</au><au>Mondou, Audrey</au><au>Reuter, Françoise</au><au>Defer, Gilles</au><au>Pelletier, Jean</au><au>Brochet, Bruno</au><au>Clavelou, Pierre</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study</atitle><jtitle>Journal of the neurological sciences</jtitle><addtitle>J Neurol Sci</addtitle><date>2017-11-15</date><risdate>2017</risdate><volume>382</volume><spage>148</spage><epage>154</epage><pages>148-154</pages><issn>0022-510X</issn><eissn>1878-5883</eissn><abstract>Health-related quality of life (HRQoL) is impaired in multiple sclerosis (MS) but can be improved by disease-modifying therapies such as natalizumab. However, the predictive factors and neuropsychiatric correlates of HRQoL improvement are unknown.
In this study, 48 patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the disease-specific MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6months, 12months, 18months and 36months after starting natalizumab therapy.
Compared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6months after the beginning of natalizumab therapy, with medium effect-size (58.6±16.2 vs 69.8±18.9, p<0.001, Cohen's d=0.63). This improvement was maintained over time for up to 3years and mainly concerned activity of daily living, psychological well-being, symptoms and coping (p<0.001 for every dimensions). The variation of global HRQoL after 3years was negatively correlated with the variation of fatigue score (r=−0.44, p=0.015). Furthermore, a higher fatigue score at baseline was correlated with improvement in global HRQoL 3years afterwards (r=0.34, p=0.041), independently of age, educational level, disease duration and disability at baseline (β=2.45, p=0.020). Disability at baseline, cognitive impairment, anxiety and depression failed to predict or correlate with global HRQoL improvement in multivariate analyses.
Natalizumab improved HRQoL quickly and sustainably in patients with relapsing-remitting MS. In terms of HRQoL, natalizumab seems to benefit mostly patients with more marked fatigue at baseline.
•Natalizumab significantly increased HRQoL 6months after the beginning of treatment.•This improvement is maintained over time for up to 3years.•The variation of HRQoL is negatively correlated with the variation of fatigue.•Higher fatigue score at baseline is independently correlated with improvement in HRQoL 3years afterwards.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>29111011</pmid><doi>10.1016/j.jns.2017.10.008</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-3713-227X</orcidid><orcidid>https://orcid.org/0000-0001-9730-7567</orcidid><orcidid>https://orcid.org/0000-0003-3824-2796</orcidid><orcidid>https://orcid.org/0000-0002-8799-0750</orcidid></addata></record> |
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| ispartof | Journal of the neurological sciences, 2017-11, Vol.382, p.148-154 |
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| subjects | Adult Cognition Depression Disability Evaluation Disease Progression Fatigue Fatigue - drug therapy Fatigue - physiopathology Fatigue - psychology Female Follow-Up Studies Health-related quality of life Humans Immunologic Factors - therapeutic use Life Sciences Male Multiple sclerosis Multiple Sclerosis, Relapsing-Remitting - drug therapy Multiple Sclerosis, Relapsing-Remitting - physiopathology Multiple Sclerosis, Relapsing-Remitting - psychology Natalizumab Natalizumab - therapeutic use Neurons and Cognition Neuropsychological Tests Quality of Life Treatment Outcome |
| title | Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study |
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