Evidence map›Paper›PMID 28923098›Full record

Trial reportArthritis research & therapy2017

Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment.

Michael Schiff, Tsutomu Takeuchi, Roy Fleischmann, Carol L Gaich, Amy M DeLozier, Douglas Schlichting, Wen-Ling Kuo, Ji-Eon Won, Tara Carmack, Terence Rooney and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01711359 (A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib), which is not on this map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 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.

NCT01711359 phase3completednot on this map

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2015Enrolled588ConditionsRheumatoid ArthritisArmsBaricitinib, Methotrexate, Baricitinib Placebo, MTX Placebo, Folic Acid
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  20. Pain and Affected Symptoms of Patients with Rheumatoid Arthritis During COVID-19 Period.Pain management nursing : official journal of the American Society of Pain Management Nurses · 2022
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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

15 authors.

Michael SchiffUniversity of Colorado School of Medicine, Denver, CO, 80045, USA. michael.schiff@me.com.
Tsutomu TakeuchiKeio University, Tokyo, Japan.
Roy FleischmannMetroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, 75231, USA.
Carol L GaichEli Lilly and Company, Indianapolis, IN, 46285, USA.
Amy M DeLozierEli Lilly and Company, Indianapolis, IN, 46285, USA.
Douglas SchlichtingEli Lilly and Company, Indianapolis, IN, 46285, USA.
Wen-Ling KuoEli Lilly and Company, Indianapolis, IN, 46285, USA.
Ji-Eon WonEli Lilly and Company, Seoul, Republic of Korea.
Tara CarmackEli Lilly and Company, Indianapolis, IN, 46285, USA.
Terence RooneyEli Lilly and Company, Indianapolis, IN, 46285, USA.
Patrick DurezService et Pôle de Rhumatologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Saeed ShaikhMcMaster University, Hamilton, ON, Canada.
Rodolfo Pardo HidalgoCER, San Juan, Argentina.
Ronald van VollenhovenAmsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.
Cristiano A F ZerbiniCentro Paulista de Investigação Clinica, São Paulo, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs.

methodsPatients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models.

resultsCompared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52.

conclusionsIn this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures.

trial registrationClinicalTrials.gov, NCT01711359 . Registered on 18 October 2012.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidAzetidinesDouble-Blind MethodFemaleHumansMaleMethotrexateMiddle AgedPatient Reported Outcome MeasuresPurinesPyrazolesSulfonamidesTreatment OutcomeAntirheumatic AgentsAzetidinesbaricitinibMethotrexatePurinesPyrazolesSulfonamidesBaricitinibHAQ-DIHealth-related quality of lifehealth status indicatorsJAK inhibitorPRORARheumatoidtsDMARD

Identifiers

PMID28923098
PMCPMC5604362

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.