AustralieFrV1, PubMed, Corpus, bibRecord, 000E91

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).

Identifieur interne : 000E91 ( PubMed/Corpus ); précédent : 000E90; suivant : 000E92

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).

Auteurs : Josef S. Smolen ; Joel M. Kremer ; Carol L. Gaich ; Amy M. Delozier ; Douglas E. Schlichting ; Li Xie ; Ivaylo Stoykov ; Terence Rooney ; Paul Bird ; Juan Miguel Sánchez Burs N ; Mark C. Genovese ; Bernard Combe

Source :

Annals of the rheumatic diseases [ 1468-2060 ] ; 2017.

RBID : pubmed:27799159

English descriptors

KwdEn :
- Adult, Arthritis, Rheumatoid (complications), Arthritis, Rheumatoid (drug therapy), Azetidines (therapeutic use), Double-Blind Method, Efficiency, Humans, Pain Measurement, Patient Reported Outcome Measures, Presenteeism, Protein Kinase Inhibitors (therapeutic use), Quality of Life, Severity of Illness Index, Sulfonamides (therapeutic use), Surveys and Questionnaires, Young Adult.
MESH :
- chemical , therapeutic use : Azetidines, Protein Kinase Inhibitors, Sulfonamides.
- complications : Arthritis, Rheumatoid.
- drug therapy : Arthritis, Rheumatoid.
- Adult, Double-Blind Method, Efficiency, Humans, Pain Measurement, Patient Reported Outcome Measures, Presenteeism, Quality of Life, Severity of Illness Index, Surveys and Questionnaires, Young Adult.

Abstract

To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).

DOI: 10.1136/annrheumdis-2016-209821
PubMed: 27799159

Links to Exploration step

pubmed:27799159

Le document en format XML

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</affiliation>
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<author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name>
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</affiliation>
</author>
<author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name>
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<author><name sortKey="Delozier, Amy M" sort="Delozier, Amy M" uniqKey="Delozier A" first="Amy M" last="Delozier">Amy M. Delozier</name>
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<author><name sortKey="Schlichting, Douglas E" sort="Schlichting, Douglas E" uniqKey="Schlichting D" first="Douglas E" last="Schlichting">Douglas E. Schlichting</name>
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<author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name>
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<author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name>
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<author><name sortKey="Sanchez Burs N, Juan Miguel" sort="Sanchez Burs N, Juan Miguel" uniqKey="Sanchez Burs N J" first="Juan Miguel" last="Sánchez Burs N">Juan Miguel Sánchez Burs N</name>
<affiliation><nlm:affiliation>Divisions of Rheumatology, Ophthalmology and Immunology, Valme University Hospital, Sevilla, Spain.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Genovese, Mark C" sort="Genovese, Mark C" uniqKey="Genovese M" first="Mark C" last="Genovese">Mark C. Genovese</name>
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<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).</title>
<author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
<affiliation><nlm:affiliation>Medical University of Vienna and Hietzing Hospital, Vienna, Austria.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name>
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<author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name>
<affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Delozier, Amy M" sort="Delozier, Amy M" uniqKey="Delozier A" first="Amy M" last="Delozier">Amy M. Delozier</name>
<affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Schlichting, Douglas E" sort="Schlichting, Douglas E" uniqKey="Schlichting D" first="Douglas E" last="Schlichting">Douglas E. Schlichting</name>
<affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name>
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</affiliation>
</author>
<author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name>
<affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name>
<affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name>
<affiliation><nlm:affiliation>University of New South Wales, Sydney, New South Wales, Australia.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Sanchez Burs N, Juan Miguel" sort="Sanchez Burs N, Juan Miguel" uniqKey="Sanchez Burs N J" first="Juan Miguel" last="Sánchez Burs N">Juan Miguel Sánchez Burs N</name>
<affiliation><nlm:affiliation>Divisions of Rheumatology, Ophthalmology and Immunology, Valme University Hospital, Sevilla, Spain.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Genovese, Mark C" sort="Genovese, Mark C" uniqKey="Genovese M" first="Mark C" last="Genovese">Mark C. Genovese</name>
<affiliation><nlm:affiliation>Stanford University Medical Center, Palo Alto, California, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
<affiliation><nlm:affiliation>Lapeyronie Hospital, Montpellier University, Montpellier, France.</nlm:affiliation>
</affiliation>
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<series><title level="j">Annals of the rheumatic diseases</title>
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<imprint><date when="2017" type="published">2017</date>
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<term>Arthritis, Rheumatoid (complications)</term>
<term>Arthritis, Rheumatoid (drug therapy)</term>
<term>Azetidines (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Efficiency</term>
<term>Humans</term>
<term>Pain Measurement</term>
<term>Patient Reported Outcome Measures</term>
<term>Presenteeism</term>
<term>Protein Kinase Inhibitors (therapeutic use)</term>
<term>Quality of Life</term>
<term>Severity of Illness Index</term>
<term>Sulfonamides (therapeutic use)</term>
<term>Surveys and Questionnaires</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Azetidines</term>
<term>Protein Kinase Inhibitors</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Double-Blind Method</term>
<term>Efficiency</term>
<term>Humans</term>
<term>Pain Measurement</term>
<term>Patient Reported Outcome Measures</term>
<term>Presenteeism</term>
<term>Quality of Life</term>
<term>Severity of Illness Index</term>
<term>Surveys and Questionnaires</term>
<term>Young Adult</term>
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<front><div type="abstract" xml:lang="en">To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27799159</PMID>
<DateCreated><Year>2016</Year>
<Month>11</Month>
<Day>01</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>06</Month>
<Day>06</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>08</Month>
<Day>01</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1468-2060</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>76</Volume>
<Issue>4</Issue>
<PubDate><Year>2017</Year>
<Month>04</Month>
</PubDate>
</JournalIssue>
<Title>Annals of the rheumatic diseases</Title>
<ISOAbbreviation>Ann. Rheum. Dis.</ISOAbbreviation>
</Journal>
<ArticleTitle>Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).</ArticleTitle>
<Pagination><MedlinePgn>694-700</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1136/annrheumdis-2016-209821</ELocationID>
<Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION NUMBER" NlmCategory="BACKGROUND">NCT01721044; Results.</AbstractText>
<CopyrightInformation>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Smolen</LastName>
<ForeName>Josef S</ForeName>
<Initials>JS</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0002-8899-9087</Identifier>
<AffiliationInfo><Affiliation>Medical University of Vienna and Hietzing Hospital, Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kremer</LastName>
<ForeName>Joel M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Albany Medical College, Albany, New York, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gaich</LastName>
<ForeName>Carol L</ForeName>
<Initials>CL</Initials>
<AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>DeLozier</LastName>
<ForeName>Amy M</ForeName>
<Initials>AM</Initials>
<AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schlichting</LastName>
<ForeName>Douglas E</ForeName>
<Initials>DE</Initials>
<AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Xie</LastName>
<ForeName>Li</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Stoykov</LastName>
<ForeName>Ivaylo</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rooney</LastName>
<ForeName>Terence</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bird</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>University of New South Wales, Sydney, New South Wales, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sánchez Bursón</LastName>
<ForeName>Juan Miguel</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Divisions of Rheumatology, Ophthalmology and Immunology, Valme University Hospital, Sevilla, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Genovese</LastName>
<ForeName>Mark C</ForeName>
<Initials>MC</Initials>
<AffiliationInfo><Affiliation>Stanford University Medical Center, Palo Alto, California, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Combe</LastName>
<ForeName>Bernard</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Lapeyronie Hospital, Montpellier University, Montpellier, France.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>10</Month>
<Day>31</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Ann Rheum Dis</MedlineTA>
<NlmUniqueID>0372355</NlmUniqueID>
<ISSNLinking>0003-4967</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D001384">Azetidines</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D047428">Protein Kinase Inhibitors</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D013449">Sulfonamides</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>ISP4442I3Y</RegistryNumber>
<NameOfSubstance UI="C000596027">baricitinib</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
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<CommentsCorrections RefType="Cites"><RefSource>Arthritis Rheum. 2008 Oct 15;59(10):1371-7</RefSource>
<PMID Version="1">18821648</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2016 Mar 31;374(13):1243-52</RefSource>
<PMID Version="1">27028914</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Arthritis Rheum. 1993 Jun;36(6):729-40</RefSource>
<PMID Version="1">8507213</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>BMJ. 1992 Jul 18;305(6846):160-4</RefSource>
<PMID Version="1">1285753</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Drugs. 2010;70(2):121-45</RefSource>
<PMID Version="1">20108988</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2013 Jan 10;368(2):161-70</RefSource>
<PMID Version="1">23301733</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Arthritis Rheum. 2006 Sep;54(9):2784-92</RefSource>
<PMID Version="1">16947781</PMID>
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<Keyword MajorTopicYN="Y">Outcomes research</Keyword>
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   |texte=   Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).
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Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).

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