Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine.
Identifieur interne : 002B92 ( Ncbi/Merge ); précédent : 002B91; suivant : 002B93Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine.
Auteurs : Richard Macdonell [Australie] ; Guy Nagels [Belgique] ; David-Axel Laplaud [France] ; Carlo Pozzilli [Italie] ; Brigit De Jong [Pays-Bas] ; Ana Martins Da Silva [Portugal] ; Richard Nicholas [Royaume-Uni] ; Jeannette Lechner-Scott [Australie] ; Julia A. Gaebler [États-Unis] ; Sonalee Agarwal [États-Unis] ; Ping Wang [États-Unis] ; Michael Yeh [États-Unis] ; Maria Hovenden [États-Unis] ; Per Soelberg S Rensen [Danemark]Source :
- Multiple sclerosis (Houndmills, Basingstoke, England) [ 1477-0970 ] ; 2016.
Abstract
Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives.
DOI: 10.1177/1352458515606809
PubMed: 26447066
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Laennec, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre Hospitalier Universitaire de Nantes, Hôpital G. et R. Laennec</wicri:regionArea><wicri:noRegion>Hôpital G. et R. Laennec</wicri:noRegion><wicri:noRegion>Hôpital G. et R. Laennec</wicri:noRegion></affiliation></author><author><name sortKey="Pozzilli, Carlo" sort="Pozzilli, Carlo" uniqKey="Pozzilli C" first="Carlo" last="Pozzilli">Carlo Pozzilli</name><affiliation wicri:level="1"><nlm:affiliation>The Department of Neurology and Psychiatry, Sapienza University, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>The Department of Neurology and Psychiatry, Sapienza University</wicri:regionArea><wicri:noRegion>Sapienza University</wicri:noRegion></affiliation></author><author><name sortKey="De Jong, Brigit" sort="De Jong, Brigit" uniqKey="De Jong B" first="Brigit" last="De Jong">Brigit De Jong</name><affiliation wicri:level="1"><nlm:affiliation>Radboud University Medical Center, Nijmegen and the Neurology Department of Jeroen Bosch Hospital, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Radboud University Medical Center, Nijmegen and the Neurology Department of Jeroen Bosch Hospital</wicri:regionArea><wicri:noRegion>Nijmegen and the Neurology Department of Jeroen Bosch Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Martins Da Silva, Ana" sort="Martins Da Silva, Ana" uniqKey="Martins Da Silva A" first="Ana" last="Martins Da Silva">Ana Martins Da Silva</name><affiliation wicri:level="1"><nlm:affiliation>Neurosciences Department, Hospital Santo António-Centro Hospitalar do Porto, Portugal.</nlm:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Neurosciences Department, Hospital Santo António-Centro Hospitalar do Porto</wicri:regionArea><wicri:noRegion>Hospital Santo António-Centro Hospitalar do Porto</wicri:noRegion></affiliation></author><author><name sortKey="Nicholas, Richard" sort="Nicholas, Richard" uniqKey="Nicholas R" first="Richard" last="Nicholas">Richard Nicholas</name><affiliation wicri:level="1"><nlm:affiliation>Imperial College, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Imperial College</wicri:regionArea></affiliation></author><author><name sortKey="Lechner Scott, Jeannette" sort="Lechner Scott, Jeannette" uniqKey="Lechner Scott J" first="Jeannette" last="Lechner-Scott">Jeannette Lechner-Scott</name><affiliation wicri:level="1"><nlm:affiliation>Hunter Medical Research Institute, The University of Newcastle, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Hunter Medical Research Institute, The University of Newcastle</wicri:regionArea><wicri:noRegion>The University of Newcastle</wicri:noRegion></affiliation></author><author><name sortKey="Gaebler, Julia A" sort="Gaebler, Julia A" uniqKey="Gaebler J" first="Julia A" last="Gaebler">Julia A. Gaebler</name><affiliation wicri:level="2"><nlm:affiliation>Biogen, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Biogen, Cambridge, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Agarwal, Sonalee" sort="Agarwal, Sonalee" uniqKey="Agarwal S" first="Sonalee" last="Agarwal">Sonalee Agarwal</name><affiliation wicri:level="2"><nlm:affiliation>Biogen, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Biogen, Cambridge, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Wang, Ping" sort="Wang, Ping" uniqKey="Wang P" first="Ping" last="Wang">Ping Wang</name><affiliation wicri:level="2"><nlm:affiliation>Biogen, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Biogen, Cambridge, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Yeh, Michael" sort="Yeh, Michael" uniqKey="Yeh M" first="Michael" last="Yeh">Michael Yeh</name><affiliation wicri:level="2"><nlm:affiliation>Biogen, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Biogen, Cambridge, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Hovenden, Maria" sort="Hovenden, Maria" uniqKey="Hovenden M" first="Maria" last="Hovenden">Maria Hovenden</name><affiliation wicri:level="2"><nlm:affiliation>Excel Scientific Solutions, Southport, CT, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Excel Scientific Solutions, Southport, CT</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Soelberg S Rensen, Per" sort="Soelberg S Rensen, Per" uniqKey="Soelberg S Rensen P" first="Per" last="Soelberg S Rensen">Per Soelberg S Rensen</name><affiliation wicri:level="1"><nlm:affiliation>Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet</wicri:regionArea><wicri:noRegion>Copenhagen University Hospital Rigshospitalet</wicri:noRegion></affiliation></author></analytic><series><title level="j">Multiple sclerosis (Houndmills, Basingstoke, England)</title><idno type="eISSN">1477-0970</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">26447066</PMID><DateCreated><Year>2016</Year><Month>06</Month><Day>03</Day></DateCreated><DateRevised><Year>2016</Year><Month>06</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1477-0970</ISSN><JournalIssue CitedMedium="Internet"><Volume>22</Volume><Issue>7</Issue><PubDate><Year>2016</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Multiple sclerosis (Houndmills, Basingstoke, England)</Title><ISOAbbreviation>Mult. Scler.</ISOAbbreviation></Journal><ArticleTitle>Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine.</ArticleTitle><Pagination><MedlinePgn>944-54</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1177/1352458515606809</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">ENABLE assessed the effect of long-term prolonged-release (PR) fampridine (dalfampridine extended release in the United States) treatment on patient-perceived health impact in patients with MS with walking impairment.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">ENABLE was a 48-week, open-label, Phase 4 study of PR-fampridine 10 mg twice daily. Patients who showed any improvement in Timed 25-Foot Walk walking speed at weeks 2 and 4 and any improvement in 12-item MS Walking Scale score at week 4 remained on treatment. The primary endpoint was change from baseline in 36-Item Short-Form Health Survey (SF-36) physical component summary (PCS) score.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">At week 4, 707/901 (78.5%) patients met the criteria to remain on treatment. Patients on treatment demonstrated significant and clinically meaningful improvements in SF-36 PCS scores from baseline (mean change (95% confidence interval)) to week 12 (4.30 (3.83, 4.78); p < 0.0001), week 24 (3.75 (3.23, 4.27); p < 0.0001), week 36 (3.46 (2.95, 3.97); p < 0.0001), and week 48 (3.24 (2.72, 3.77); p < 0.0001). Significant improvements from baseline were also demonstrated in secondary health measures in patients on treatment.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">PR-fampridine improved patient-perceived physical and psychological health impact of MS measured in a real-life setting.</AbstractText><CopyrightInformation>© The Author(s), 2015.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Macdonell</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Department of Neurology, Austin Health, University of Melbourne, Australia Richard.Macdonell@austin.org.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nagels</LastName><ForeName>Guy</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>National Multiple Sclerosis Center Melsbroek and Center for Neurosciences, Vrije Universiteit Brussel, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Laplaud</LastName><ForeName>David-Axel</ForeName><Initials>DA</Initials><AffiliationInfo><Affiliation>Centre Hospitalier Universitaire de Nantes, Hôpital G. et R. Laennec, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pozzilli</LastName><ForeName>Carlo</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>The Department of Neurology and Psychiatry, Sapienza University, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Jong</LastName><ForeName>Brigit</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Radboud University Medical Center, Nijmegen and the Neurology Department of Jeroen Bosch Hospital, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Martins da Silva</LastName><ForeName>Ana</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Neurosciences Department, Hospital Santo António-Centro Hospitalar do Porto, Portugal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nicholas</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Imperial College, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lechner-Scott</LastName><ForeName>Jeannette</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Hunter Medical Research Institute, The University of Newcastle, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gaebler</LastName><ForeName>Julia A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Biogen, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Agarwal</LastName><ForeName>Sonalee</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Biogen, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Ping</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Biogen, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yeh</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Biogen, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hovenden</LastName><ForeName>Maria</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Excel Scientific Solutions, Southport, CT, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Soelberg Sørensen</LastName><ForeName>Per</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, Denmark.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>10</Month><Day>07</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Mult Scler</MedlineTA><NlmUniqueID>9509185</NlmUniqueID><ISSNLinking>1352-4585</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Fampridine</Keyword><Keyword MajorTopicYN="N">multiple sclerosis</Keyword><Keyword MajorTopicYN="N">patient-reported outcome</Keyword><Keyword MajorTopicYN="N">quality of life</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>02</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>08</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>10</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>10</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>10</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26447066</ArticleId><ArticleId IdType="pii">1352458515606809</ArticleId><ArticleId IdType="doi">10.1177/1352458515606809</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Danemark</li><li>France</li><li>Italie</li><li>Pays-Bas</li><li>Portugal</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Connecticut</li><li>Massachusetts</li><li>Victoria (État)</li></region><settlement><li>Melbourne</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="Australie"><region name="Victoria (État)"><name sortKey="Macdonell, Richard" sort="Macdonell, Richard" uniqKey="Macdonell R" first="Richard" last="Macdonell">Richard Macdonell</name></region><name sortKey="Lechner Scott, Jeannette" sort="Lechner Scott, Jeannette" uniqKey="Lechner Scott J" first="Jeannette" last="Lechner-Scott">Jeannette Lechner-Scott</name></country><country name="Belgique"><noRegion><name sortKey="Nagels, Guy" sort="Nagels, Guy" uniqKey="Nagels G" first="Guy" last="Nagels">Guy Nagels</name></noRegion></country><country name="France"><noRegion><name sortKey="Laplaud, David Axel" sort="Laplaud, David Axel" uniqKey="Laplaud D" first="David-Axel" last="Laplaud">David-Axel Laplaud</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Pozzilli, Carlo" sort="Pozzilli, Carlo" uniqKey="Pozzilli C" first="Carlo" last="Pozzilli">Carlo Pozzilli</name></noRegion></country><country name="Pays-Bas"><noRegion><name sortKey="De Jong, Brigit" sort="De Jong, Brigit" uniqKey="De Jong B" first="Brigit" last="De Jong">Brigit De Jong</name></noRegion></country><country name="Portugal"><noRegion><name sortKey="Martins Da Silva, Ana" sort="Martins Da Silva, Ana" uniqKey="Martins Da Silva A" first="Ana" last="Martins Da Silva">Ana Martins Da Silva</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Nicholas, Richard" sort="Nicholas, Richard" uniqKey="Nicholas R" first="Richard" last="Nicholas">Richard Nicholas</name></noRegion></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Gaebler, Julia A" sort="Gaebler, Julia A" uniqKey="Gaebler J" first="Julia A" last="Gaebler">Julia A. Gaebler</name></region><name sortKey="Agarwal, Sonalee" sort="Agarwal, Sonalee" uniqKey="Agarwal S" first="Sonalee" last="Agarwal">Sonalee Agarwal</name><name sortKey="Hovenden, Maria" sort="Hovenden, Maria" uniqKey="Hovenden M" first="Maria" last="Hovenden">Maria Hovenden</name><name sortKey="Wang, Ping" sort="Wang, Ping" uniqKey="Wang P" first="Ping" last="Wang">Ping Wang</name><name sortKey="Yeh, Michael" sort="Yeh, Michael" uniqKey="Yeh M" first="Michael" last="Yeh">Michael Yeh</name></country><country name="Danemark"><noRegion><name sortKey="Soelberg S Rensen, Per" sort="Soelberg S Rensen, Per" uniqKey="Soelberg S Rensen P" first="Per" last="Soelberg S Rensen">Per Soelberg S Rensen</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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