Evidence map›Paper›PMID 27799159›Full record

Trial reportAnnals of the rheumatic diseases2017

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).

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 Bursón and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized 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 NCT01721044 (A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib), which is not on this map. Cited by 61 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing 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.

NCT01721044 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

TypeinterventionalSponsorEli Lilly and CompanyRan2013 to 2014Enrolled527ConditionsRheumatoid ArthritisArmsPlacebo, Baricitinib, cDMARD
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 7 syntheses or guidelines pooled it, 112 citations in OpenAlex.

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1 more citing papers are in PubMed but not listed here.

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

12 authors at 7 institutions in 5 countries.

Josef S SmolenMedical University of Vienna and Hietzing Hospital, Vienna, Austria.ORCID http://orcid.org/0000-0002-8899-9087
Joel M KremerAlbany Medical College, Albany, New York, USA.
Carol L GaichEli Lilly and Company, Indianapolis, Indiana, USA.
Amy M DeLozierEli Lilly and Company, Indianapolis, Indiana, USA.
Douglas E SchlichtingEli Lilly and Company, Indianapolis, Indiana, USA.
Li XieEli Lilly and Company, Indianapolis, Indiana, USA.
Ivaylo StoykovEli Lilly and Company, Indianapolis, Indiana, USA.
Terence RooneyEli Lilly and Company, Indianapolis, Indiana, USA.
Paul BirdUniversity of New South Wales, Sydney, New South Wales, Australia.
Juan Miguel Sánchez BursónDivisions of Rheumatology, Ophthalmology and Immunology, Valme University Hospital, Sevilla, Spain.
Mark C GenoveseStanford University Medical Center, Palo Alto, California, USA.
Bernard CombeLapeyronie Hospital, Montpellier University, Montpellier, France.
Eli Lilly (United States) · USAlbany Medical Center Hospital · USHospital Universitario de Valme · ESKlinik Hietzing · ATStanford Medicine · USUniversité de Montpellier · FRUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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).

methodsIn 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.

results527 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).

conclusionsBaricitinib 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.

Indexed as

Patient Reported Outcome MeasuresAdultArthritis, RheumatoidAzetidinesDouble-Blind MethodEfficiencyHumansPain MeasurementPresenteeismProtein Kinase InhibitorsPurinesPyrazolesQuality of LifeSeverity of Illness IndexSulfonamidesSurveys and QuestionnairesAzetidinesbaricitinibProtein Kinase InhibitorsPurinesPyrazolesSulfonamidesDMARDs (biologic)DMARDs (synthetic)Outcomes researchPatient perspectiveRheumatoid Arthritis

Identifiers

PMID27799159
PMCPMC5530360
OpenAlexW2540974094

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.