Evidence map›Paper›PMID 27723271›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2017

Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment.

Roy Fleischmann, Michael Schiff, Désirée van der Heijde, Cesar Ramos-Remus, Alberto Spindler, Marina Stanislav, Cristiano A F Zerbini, Sirel Gurbuz, Christina Dickson, Stephanie de Bono and 6 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 203 papers, 29 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
203citing papers in PubMed, 29 pooled it
34.1field-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.

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
NCT05827497 phase4unknown statusnot on this mapstarted 2023, after this paper: background citation

Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial

TypeinterventionalSponsorBangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshRan2023 to 2024Enrolled132ConditionsRheumatoid ArthritisArmsBaricitinib 2 MG, Methotrexate 25mg
3 · Its place in the literature

Who cites it

203 citing papers in PubMed, 29 syntheses or guidelines pooled it, 411 citations in OpenAlex.

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  5. European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
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  20. Efficacy of methotrexate in reducing the risk of bone erosion in patients with rheumatoid arthritis: a systematic review of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Pooled it

143 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

16 authors at 7 institutions in 5 countries.

Roy FleischmannMetroplex Clinical Research Center, Dallas, Texas.
Michael SchiffUniversity of Colorado, Denver.
Désirée van der HeijdeLeiden University Medical Center, Leiden, The Netherlands, and Imaging Rheumatology BV, Meerssen, The Netherlands.
Cesar Ramos-RemusUnidad de Investigacion en Enfermedades Cronico-Degenerativas, Guadalajara, Mexico.
Alberto SpindlerCentro Medico Privado de Reumatologia, Tucuman, Argentina.
Marina StanislavScientific Research Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russia.
Cristiano A F ZerbiniCentro Paulista de Investigação Clinica, São Paulo, Brazil.
Sirel GurbuzEli Lilly and Company, Indianapolis, Indiana.
Christina DicksonEli Lilly and Company, Indianapolis, Indiana.
Stephanie de BonoEli Lilly and Company, Indianapolis, Indiana.
Douglas SchlichtingEli Lilly and Company, Indianapolis, Indiana.
Scott BeattieEli Lilly and Company, Indianapolis, Indiana.
Wen-Ling KuoEli Lilly and Company, Indianapolis, Indiana.
Terence RooneyEli Lilly and Company, Indianapolis, Indiana.
William MaciasEli Lilly and Company, Indianapolis, Indiana.
Tsutomu TakeuchiKeio University School of Medicine, Tokyo, Japan.
Eli Lilly (United States) · USCentro Paulista de Investigação Clinica · BRHospital Privado · ARKeio University · JPLeiden University Medical Center · NLMetroplex Clinical Research Center · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe undertook this phase III study to evaluate baricitinib, an orally administered JAK-1/JAK-2 inhibitor, as monotherapy or combined with methotrexate (MTX) compared to MTX monotherapy in patients with active rheumatoid arthritis (RA) who had received no or minimal conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and who were naive to biologic DMARDs.

methodsA total of 588 patients were randomized 4:3:4 to receive MTX monotherapy (once weekly), baricitinib monotherapy (4 mg once daily), or the combination of baricitinib and MTX for 52 weeks. The primary end point assessment was a noninferiority comparison of baricitinib monotherapy to MTX monotherapy based on the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 24.

resultsThe study met its primary objective. Moreover, baricitinib monotherapy was found to be superior to MTX monotherapy at week 24, with a higher ACR20 response rate (77% versus 62%; P ≤ 0.01). Similar results were observed for combination therapy. Compared to MTX monotherapy, significant improvements in disease activity and physical function were observed for both baricitinib groups as early as week 1. Radiographic progression was reduced in both baricitinib groups compared to MTX monotherapy; the difference was statistically significant for baricitinib plus MTX. The rates of serious adverse events (AEs) were similar across treatment groups, while rates of some treatment-emergent AEs, including infections, were increased with baricitinib plus MTX. Three deaths were reported, all occurring in the MTX monotherapy group. Malignancies, including nonmelanoma skin cancer, were reported in 1 patient receiving MTX monotherapy, 1 receiving baricitinib monotherapy, and 4 receiving baricitinib plus MTX.

conclusionBaricitinib alone or in combination with MTX demonstrated superior efficacy with acceptable safety compared to MTX monotherapy as initial therapy for patients with active RA.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAzetidinesDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedPurinesPyrazolesSulfonamidesAntirheumatic AgentsAzetidinesbaricitinibMethotrexatePurinesPyrazolesSulfonamides

Identifiers

PMID27723271
PMCPMC5347954
OpenAlexW2530335997

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.