Evidence map›Paper›PMID 28798049›Full record

Trial reportAnnals of the rheumatic diseases2017

Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study.

Edward C Keystone, Peter C Taylor, Yoshiya Tanaka, Carol Gaich, Amy M DeLozier, Anna Dudek, Jorge Velasco Zamora, Jose Arturo Covarrubias Cobos, Terence Rooney, Stephanie de Bono and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01710358 (A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy), which is not on this map. Cited by 60 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 7 pooled it
10.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01710358 phase3completednot on this map

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2015Enrolled1,307ConditionsRheumatoid ArthritisArmsAdalimumab, Baricitinib, Methotrexate, Adalimumab Placebo, Baricitinib Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 7 syntheses or guidelines pooled it, 117 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 4 countries.

Edward C KeystoneThe Rebecca MacDonald Centre for Arthritis, Mt. Sinai Hospital, Toronto, Canada.
Peter C TaylorKennedy Institute of Rheumatology, University of Oxford, Oxford, UK.
Yoshiya TanakaUniversity of Occupational and Environmental Health, Fukuoka, Japan.
Carol GaichEli Lilly and Company, Indianapolis, Indiana, USA.
Amy M DeLozierEli Lilly and Company, Indianapolis, Indiana, USA.
Anna DudekMedica Pro Familia, Warsaw, Poland.
Jorge Velasco ZamoraInstituto Médico CER, Buenos Aires, Argentina.
Jose Arturo Covarrubias CobosUnidad Reumatologica Las Americas S.C.P. Médico, Mexico, USA.
Terence RooneyEli Lilly and Company, Indianapolis, Indiana, USA.
Stephanie de BonoEli Lilly and Company, Indianapolis, Indiana, USA.
Vipin AroraEli Lilly and Company, Indianapolis, Indiana, USA.
Bruno LinetzkyEli Lilly and Company, Indianapolis, Indiana, USA.
Michael E WeinblattBrigham and Women's Hospital, Boston, Massachusetts, USA.
Eli Lilly (United States) · USBrigham and Women's Hospital · USUniversity of Occupational and Environmental Health Japan · JPUniversity of Oxford · GBUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX).

methodsIn this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330) with background MTX. PROs included the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analogue scale, 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 and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and measures collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was at week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables.

resultsCompared with placebo and adalimumab, baricitinib showed statistically significant improvements (p≤0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures assessed to week 52. Statistically significant improvement in patient diary measures (MJS duration and severity), worst tiredness and worst joint pain were observed for baricitinib versus placebo and adalimumab at week 12 (p≤0.05).

conclusionsBaricitinib provided significantly greater improvement in most PROs compared with placebo and adalimumab, including physical function MJS, pain, fatigue and quality of life. Improvement was maintained to the end of the study (week 52).

trial registrationNCT01710358.

Indexed as

Patient Reported Outcome MeasuresAdalimumabAdultAnalysis of VarianceAntirheumatic AgentsArthralgiaArthritis, RheumatoidAzetidinesDouble-Blind MethodFatigueFemaleHumansLogistic ModelsMaleMiddle AgedPain MeasurementAdalimumabAntirheumatic AgentsAzetidinesbaricitinibPurinesPyrazolesSulfonamidesoutcomes researchpatient perspectiverheumatoid arthritis

Identifiers

PMID28798049
PMCPMC5705852
OpenAlexW2742515995

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.