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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)

Identifieur interne : 001978 ( Main/Exploration ); précédent : 001977; suivant : 001979

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 [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 :

RBID : PMC:5530360

Descripteurs français

English descriptors

Abstract

Objectives

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).

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.

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).

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.

Trial registration number

NCT01721044; Results.


Url:
DOI: 10.1136/annrheumdis-2016-209821
PubMed: 27799159
PubMed Central: 5530360


Affiliations:


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<country xml:lang="fr">États-Unis</country>
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<country xml:lang="fr">Australie</country>
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<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>
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<country xml:lang="fr">Espagne</country>
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<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>
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<term>Quality of Life</term>
<term>Severity of Illness Index</term>
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<term>Inhibiteurs de protéines kinases (usage thérapeutique)</term>
<term>Jeune adulte</term>
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<term>Qualité de vie</term>
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<term>Arthritis, Rheumatoid</term>
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<term>Polyarthrite rhumatoïde</term>
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<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>
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<term>Adulte</term>
<term>Enquêtes et questionnaires</term>
<term>Humains</term>
<term>Indice de gravité médicale</term>
<term>Jeune adulte</term>
<term>Mesure de la douleur</term>
<term>Mesures des résultats rapportés par les patients</term>
<term>Méthode en double aveugle</term>
<term>Polyarthrite rhumatoïde</term>
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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>
</div>
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