Evidence map›Paper›PMID 27689735›Full record

Trial reportAnnals of the rheumatic diseases2017

Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study.

Maxime Dougados, Désirée van der Heijde, Ying-Chou Chen, Maria Greenwald, Edit Drescher, Jiajun Liu, Scott Beattie, Sarah Witt, Inmaculada de la Torre, Carol Gaich and 4 more

Erratum issued 2 registry-linked trialsAbstract 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. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 196 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
196citing papers in PubMed, 22 pooled it
–field-weighted citation impact
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.

NCT01721057 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2014Enrolled684ConditionsRheumatoid ArthritisArmsPlacebo, Baricitinib, cDMARD
NCT05660655 phase4completednot on this mapstarted 2022, after this paper: background citation

Efficacy and Safety of Baricitinib in Different Doses for the Treatment of Moderate to Severe Rheumatoid Arthritis

TypeinterventionalSponsorBangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshRan2022 to 2023Enrolled94ConditionsRheumatoid ArthritisArmsBaricitinib 4 MG Oral Tablet, Baricitinib 2 MG
3 · Its place in the literature

Who cites it

196 citing papers in PubMed, 22 syntheses or guidelines pooled it.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Maxime DougadosDepartment of Rheumatology, Paris Descartes University, Hôpital Cochin, Assistance Publique, Hôpitaux de Paris, INSERM (U1151), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France.
Désirée van der HeijdeLeiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5781-158X
Ying-Chou ChenDivision of Rheumatology, Department of Internal Medicine, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan; Chang Gung Memorial Hospital - Kaohsiung Medical Center, Chang Gung University College of Medicine, Taiwan.
Maria GreenwaldDesert Medical Advances, Palm Desert, California, USA.
Edit DrescherVeszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.
Jiajun LiuEli Lilly and Company, Indianapolis, Indiana, USA.
Scott BeattieEli Lilly and Company, Indianapolis, Indiana, USA.
Sarah WittEli Lilly and Company, Indianapolis, Indiana, USA.
Inmaculada de la TorreEli Lilly and Company, Indianapolis, Indiana, USA.
Carol GaichEli Lilly and Company, Indianapolis, Indiana, USA.
Terence RooneyEli Lilly and Company, Indianapolis, Indiana, USA.
Douglas SchlichtingEli Lilly and Company, Indianapolis, Indiana, USA.
Stephanie de BonoEli Lilly and Company, Indianapolis, Indiana, USA.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, NIHR Leeds Musculoskeletal Biomedical Research Unit, LTHT, University of Leeds, Leeds, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBaricitinib is an oral, reversible, selective Janus kinase 1 and 2 inhibitor.

methodsIn this phase III, double-blind 24-week study, 684 biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with rheumatoid arthritis and inadequate response or intolerance to ≥1 conventional synthetic DMARDs were randomly assigned 1:1:1 to placebo or baricitinib (2 or 4 mg) once daily, stratified by region and the presence of joint erosions. Endpoint measures included American College of Rheumatology 20% response (ACR20, primary endpoint), Disease Activity Score (DAS28) and Simplified Disease Activity Index (SDAI) score ≤3.3.

resultsMore patients achieved ACR20 response at week 12 with baricitinib 4 mg than with placebo (62% vs 39%, p≤0.001). Compared with placebo, statistically significant improvements in DAS28, SDAI remission, Health Assessment Questionnaire-Disability Index, morning joint stiffness, worst joint pain and worst tiredness were observed. In a supportive analysis, radiographic progression of structural joint damage at week 24 was reduced with baricitinib versus placebo. Rates of adverse events during the treatment period and serious adverse events (SAEs), including serious infections, were similar among groups (SAEs: 5% for baricitinib 4 mg and placebo). One patient had an adverse event of tuberculosis (baricitinib 4 mg); one patient had an adverse event of non-melanoma skin cancer (baricitinib 4 mg). Two deaths and three major adverse cardiovascular events occurred (placebo). Baricitinib was associated with a decrease in neutrophils and increases in low-density and high-density lipoprotein.

conclusionsIn patients with rheumatoid arthritis and an inadequate response or intolerance to conventional synthetic DMARDs, baricitinib was associated with clinical improvement and inhibition of progression of radiographic joint damage. TRIAL REGISTRATION NUMBER: NCT01721057; Results.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidAzetidinesDouble-Blind MethodFemaleHumansJanus Kinase 1Janus Kinase 2MaleMiddle AgedProtein Kinase InhibitorsPurinesPyrazolesRadiographyRetreatmentAntirheumatic AgentsAzetidinesbaricitinibJanus Kinase 1Janus Kinase 2Protein Kinase InhibitorsPurinesPyrazolesSulfonamidesDMARDs (synthetic)Rheumatoid ArthritisTreatment

Identifiers

PMID27689735
PMCPMC5264214

What OpenQuestion holds

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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.