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 : 002108 ( Pmc/Curation ); précédent : 002107; suivant : 002109Patient-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 [Autriche] ; Joel M. Kremer [États-Unis] ; Carol L. Gaich [États-Unis] ; Amy M. Delozier [États-Unis] ; Douglas E. Schlichting [États-Unis] ; Li Xie [États-Unis] ; Ivaylo Stoykov [États-Unis] ; Terence Rooney [États-Unis] ; Paul Bird [Australie] ; Juan Miguel Sánchez Burs N [Espagne] ; Mark C. Genovese [États-Unis] ; Bernard Combe [France]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2016.
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).
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.
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).
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.
Url:
DOI: 10.1136/annrheumdis-2016-209821
PubMed: 27799159
PubMed Central: 5530360
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: Pour aller vers cette notice dans l'étape Curation :002258
Links to Exploration step
PMC:5530360Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><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 wicri:level="1"><nlm:aff id="af1"><institution>Medical University of Vienna and Hietzing Hospital</institution>,<addr-line>Vienna</addr-line>,<country>Austria</country></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Albany Medical College</institution>,<addr-line>Albany, New York</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>University of New South Wales</institution>,<addr-line>Sydney, New South Wales</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af5"><addr-line>Divisions of Rheumatology, Ophthalmology and Immunology</addr-line>,<institution>Valme University Hospital</institution>,<addr-line>Sevilla</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af6"><institution>Stanford University Medical Center</institution>,<addr-line>Palo Alto, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Lapeyronie Hospital, Montpellier University</institution>,<addr-line>Montpellier</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27799159</idno><idno type="pmc">5530360</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5530360</idno><idno type="RBID">PMC:5530360</idno><idno type="doi">10.1136/annrheumdis-2016-209821</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">002258</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002258</idno><idno type="wicri:Area/Pmc/Curation">002108</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002108</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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 wicri:level="1"><nlm:aff id="af1"><institution>Medical University of Vienna and Hietzing Hospital</institution>,<addr-line>Vienna</addr-line>,<country>Austria</country></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Albany Medical College</institution>,<addr-line>Albany, New York</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>University of New South Wales</institution>,<addr-line>Sydney, New South Wales</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af5"><addr-line>Divisions of Rheumatology, Ophthalmology and Immunology</addr-line>,<institution>Valme University Hospital</institution>,<addr-line>Sevilla</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="af6"><institution>Stanford University Medical Center</institution>,<addr-line>Palo Alto, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Lapeyronie Hospital, Montpellier University</institution>,<addr-line>Montpellier</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of the Rheumatic Diseases</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives</title><p>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).</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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).</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Trial registration number</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01721044">NCT01721044</ext-link>; Results.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Carr, A" uniqKey="Carr A">A Carr</name></author><author><name sortKey="Hewlett, S" uniqKey="Hewlett S">S Hewlett</name></author><author><name sortKey="Hughes, R" uniqKey="Hughes R">R Hughes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Strand, V" uniqKey="Strand V">V Strand</name></author><author><name sortKey="Cohen, S" uniqKey="Cohen S">S Cohen</name></author><author><name sortKey="Crawford, B" uniqKey="Crawford B">B Crawford</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Klarenbeek, Nb" uniqKey="Klarenbeek N">NB Klarenbeek</name></author><author><name sortKey="Guler Yuksel, M" uniqKey="Guler Yuksel M">M Güler-Yüksel</name></author><author><name sortKey="Van Der Kooij, Sm" uniqKey="Van Der Kooij S">SM van der Kooij</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Drossaers Bakker, Kw" uniqKey="Drossaers Bakker K">KW Drossaers-Bakker</name></author><author><name sortKey="De Buck, M" uniqKey="De Buck M">M de Buck</name></author><author><name sortKey="Van Zeben, D" uniqKey="Van Zeben D">D van Zeben</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Aletaha, D" uniqKey="Aletaha D">D Aletaha</name></author><author><name sortKey="Smolen, J" uniqKey="Smolen J">J Smolen</name></author><author><name sortKey="Ward, Mm" uniqKey="Ward M">MM Ward</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Aletaha, D" uniqKey="Aletaha D">D Aletaha</name></author><author><name sortKey="Grisar, Jc" uniqKey="Grisar J">JC Grisar</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Aletaha, D" uniqKey="Aletaha D">D Aletaha</name></author><author><name sortKey="Strand, V" uniqKey="Strand V">V Strand</name></author><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Aletaha, D" uniqKey="Aletaha D">D Aletaha</name></author><author><name sortKey="Ward, Mm" uniqKey="Ward M">MM Ward</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Aletaha, D" uniqKey="Aletaha D">D Aletaha</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Landewe, R" uniqKey="Landewe R">R Landewé</name></author><author><name sortKey="Breedveld, Fc" uniqKey="Breedveld F">FC Breedveld</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Singh, Ja" uniqKey="Singh J">JA Singh</name></author><author><name sortKey="Saag, Kg" uniqKey="Saag K">KG Saag</name></author><author><name sortKey="Bridges, Sl" uniqKey="Bridges S">SL Bridges</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sanderson, T" uniqKey="Sanderson T">T Sanderson</name></author><author><name sortKey="Morris, M" uniqKey="Morris M">M Morris</name></author><author><name sortKey="Calnan, M" uniqKey="Calnan M">M Calnan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gossec, L" uniqKey="Gossec L">L Gossec</name></author><author><name sortKey="Dougados, M" uniqKey="Dougados M">M Dougados</name></author><author><name sortKey="Dixon, W" uniqKey="Dixon W">W Dixon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Aletaha, D" uniqKey="Aletaha D">D Aletaha</name></author><author><name sortKey="Landewe, R" uniqKey="Landewe R">R Landewe</name></author><author><name sortKey="Karonitsch, T" uniqKey="Karonitsch T">T Karonitsch</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="O Shea, Jj" uniqKey="O Shea J">JJ O'Shea</name></author><author><name sortKey="Holland, Sm" uniqKey="Holland S">SM Holland</name></author><author><name sortKey="Staudt, Lm" uniqKey="Staudt L">LM Staudt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name></author><author><name sortKey="Kremer, J" uniqKey="Kremer J">J Kremer</name></author><author><name sortKey="Zamani, O" uniqKey="Zamani O">O Zamani</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Brazier, Je" uniqKey="Brazier J">JE Brazier</name></author><author><name sortKey="Harper, R" uniqKey="Harper R">R Harper</name></author><author><name sortKey="Jones, Nm" uniqKey="Jones N">NM Jones</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ware, Je" uniqKey="Ware J">JE Ware</name></author><author><name sortKey="Sherbourne, Cd" uniqKey="Sherbourne C">CD Sherbourne</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Strand, V" uniqKey="Strand V">V Strand</name></author><author><name sortKey="Singh, Ja" uniqKey="Singh J">JA Singh</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kosinski, M" uniqKey="Kosinski M">M Kosinski</name></author><author><name sortKey="Zhao, Sz" uniqKey="Zhao S">SZ Zhao</name></author><author><name sortKey="Dedhiya, S" uniqKey="Dedhiya S">S Dedhiya</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Brooks, R" uniqKey="Brooks R">R Brooks</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Herdman, M" uniqKey="Herdman M">M Herdman</name></author><author><name sortKey="Gudex, C" uniqKey="Gudex C">C Gudex</name></author><author><name sortKey="Lloyd, A" uniqKey="Lloyd A">A Lloyd</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cella, D" uniqKey="Cella D">D Cella</name></author><author><name sortKey="Yount, S" uniqKey="Yount S">S Yount</name></author><author><name sortKey="Sorensen, M" uniqKey="Sorensen M">M Sorensen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Strand, V" uniqKey="Strand V">V Strand</name></author><author><name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name></author><author><name sortKey="Zerbini, Ca" uniqKey="Zerbini C">CA Zerbini</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Keystone, E" uniqKey="Keystone E">E Keystone</name></author><author><name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name></author><author><name sortKey="Furie, R" uniqKey="Furie R">R Furie</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bruce, B" uniqKey="Bruce B">B Bruce</name></author><author><name sortKey="Fries, Jf" uniqKey="Fries J">JF Fries</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ramey, Dr" uniqKey="Ramey D">DR Ramey</name></author><author><name sortKey="Fries, Jf" uniqKey="Fries J">JF Fries</name></author><author><name sortKey="Singh, G" uniqKey="Singh G">G Singh</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wells, Ga" uniqKey="Wells G">GA Wells</name></author><author><name sortKey="Tugwell, P" uniqKey="Tugwell P">P Tugwell</name></author><author><name sortKey="Kraag, Gr" uniqKey="Kraag G">GR Kraag</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Reilly, Mc" uniqKey="Reilly M">MC Reilly</name></author><author><name sortKey="Zbrozek, As" uniqKey="Zbrozek A">AS Zbrozek</name></author><author><name sortKey="Dukes, Em" uniqKey="Dukes E">EM Dukes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Navarro Compan, V" uniqKey="Navarro Compan V">V Navarro-Compán</name></author><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Huizinga, Twj" uniqKey="Huizinga T">TWJ Huizinga</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Felson, Dt" uniqKey="Felson D">DT Felson</name></author><author><name sortKey="Anderson, Jj" uniqKey="Anderson J">JJ Anderson</name></author><author><name sortKey="Boers, M" uniqKey="Boers M">M Boers</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Strand, V" uniqKey="Strand V">V Strand</name></author><author><name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name></author><author><name sortKey="Ogale, S" uniqKey="Ogale S">S Ogale</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Westhovens, R" uniqKey="Westhovens R">R Westhovens</name></author><author><name sortKey="Cole, Jc" uniqKey="Cole J">JC Cole</name></author><author><name sortKey="Li, T" uniqKey="Li T">T Li</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Kay, J" uniqKey="Kay J">J Kay</name></author><author><name sortKey="Doyle, Mk" uniqKey="Doyle M">MK Doyle</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Strand, V" uniqKey="Strand V">V Strand</name></author><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Van Vollenhoven, Rf" uniqKey="Van Vollenhoven R">RF van Vollenhoven</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Keystone, Ec" uniqKey="Keystone E">EC Keystone</name></author><author><name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name></author><author><name sortKey="Klareskog, L" uniqKey="Klareskog L">L Klareskog</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name></author><author><name sortKey="Blanco, R" uniqKey="Blanco R">R Blanco</name></author><author><name sortKey="Charles Schoeman, C" uniqKey="Charles Schoeman C">C Charles-Schoeman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Keystone, Ec" uniqKey="Keystone E">EC Keystone</name></author><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Kavanaugh, A" uniqKey="Kavanaugh A">A Kavanaugh</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name></author><author><name sortKey="Schiff, M" uniqKey="Schiff M">M Schiff</name></author><author><name sortKey="Luggen, M" uniqKey="Luggen M">M Luggen</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="iso-abbrev">Ann. Rheum. Dis</journal-id><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title-group><journal-title>Annals of the Rheumatic Diseases</journal-title></journal-title-group><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group</publisher-name><publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27799159</article-id><article-id pub-id-type="pmc">5530360</article-id><article-id pub-id-type="publisher-id">annrheumdis-2016-209821</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2016-209821</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject></subj-group><subj-group subj-group-type="heading"><subject>Clinical and Epidemiological Research</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>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)</article-title></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid" authenticated="false">http://orcid.org/0000-0002-8899-9087</contrib-id><name><surname>Smolen</surname><given-names>Josef S</given-names></name><xref ref-type="aff" rid="af1">1</xref></contrib><contrib contrib-type="author"><name><surname>Kremer</surname><given-names>Joel M</given-names></name><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Gaich</surname><given-names>Carol L</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>DeLozier</surname><given-names>Amy M</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Schlichting</surname><given-names>Douglas E</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Xie</surname><given-names>Li</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Stoykov</surname><given-names>Ivaylo</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Rooney</surname><given-names>Terence</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Bird</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Sánchez Bursón</surname><given-names>Juan Miguel</given-names></name><xref ref-type="aff" rid="af5">5</xref></contrib><contrib contrib-type="author"><name><surname>Genovese</surname><given-names>Mark C</given-names></name><xref ref-type="aff" rid="af6">6</xref></contrib><contrib contrib-type="author"><name><surname>Combe</surname><given-names>Bernard</given-names></name><xref ref-type="aff" rid="af7">7</xref></contrib></contrib-group><aff id="af1"><label>1</label><institution>Medical University of Vienna and Hietzing Hospital</institution>,<addr-line>Vienna</addr-line>,<country>Austria</country></aff><aff id="af2"><label>2</label><institution>Albany Medical College</institution>,<addr-line>Albany, New York</addr-line>,<country>USA</country></aff><aff id="af3"><label>3</label><institution>Eli Lilly and Company</institution>,<addr-line>Indianapolis, Indiana</addr-line>,<country>USA</country></aff><aff id="af4"><label>4</label><institution>University of New South Wales</institution>,<addr-line>Sydney, New South Wales</addr-line>,<country>Australia</country></aff><aff id="af5"><label>5</label><addr-line>Divisions of Rheumatology, Ophthalmology and Immunology</addr-line>,<institution>Valme University Hospital</institution>,<addr-line>Sevilla</addr-line>,<country>Spain</country></aff><aff id="af6"><label>6</label><institution>Stanford University Medical Center</institution>,<addr-line>Palo Alto, California</addr-line>,<country>USA</country></aff><aff id="af7"><label>7</label><institution>Lapeyronie Hospital, Montpellier University</institution>,<addr-line>Montpellier</addr-line>,<country>France</country></aff><author-notes><fn><p><bold>Handling editor</bold> Tore K Kvien</p></fn><corresp><label>Correspondence to</label> Professor Josef S Smolen, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2nd Department of Medicine, Hietzing Hospital, Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria; <email>josef.smolen@wienkav.at</email></corresp></author-notes><pub-date pub-type="ppub"><month>4</month><year>2017</year></pub-date><pub-date pub-type="epub"><day>31</day><month>10</month><year>2016</year></pub-date><volume>76</volume><issue>4</issue><fpage>694</fpage><lpage>700</lpage><history><date date-type="received"><day>2</day><month>5</month><year>2016</year></date><date date-type="rev-recd"><day>9</day><month>9</month><year>2016</year></date><date date-type="accepted"><day>5</day><month>10</month><year>2016</year></date></history><permissions><copyright-statement>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/</copyright-statement><copyright-year>2016</copyright-year><license license-type="open-access"><license-p>This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">http://creativecommons.org/licenses/by-nc/4.0/</ext-link></license-p></license></permissions><self-uri xlink:title="pdf" xlink:href="annrheumdis-2016-209821.pdf"></self-uri><abstract><sec><title>Objectives</title><p>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).</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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).</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Trial registration number</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01721044">NCT01721044</ext-link>; Results.</p></sec></abstract><kwd-group><kwd>DMARDs (synthetic)</kwd><kwd>DMARDs (biologic)</kwd><kwd>Patient perspective</kwd><kwd>Rheumatoid Arthritis</kwd><kwd>Outcomes research</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>special-feature</meta-name><meta-value>unlocked</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Pmc/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002108 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd -nk 002108 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Asie
|area= AustralieFrV1
|flux= Pmc
|étape= Curation
|type= RBID
|clé= PMC:5530360
|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)
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Curation/RBID.i -Sk "pubmed:27799159" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd \
| NlmPubMed2Wicri -a AustralieFrV1
| This area was generated with Dilib version V0.6.33. |  |