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
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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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,<addr-line>Montpellier</addr-line>
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<country xml:lang="fr">France</country>
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<series><title level="j">Annals of the Rheumatic Diseases</title>
<idno type="ISSN">0003-4967</idno>
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<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>
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<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>
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