Evidence map›Paper›PMID 36371760›Full record

ArticleRheumatology and therapy2023

Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases.

Claudia A Salinas, Anthony Louder, Jennifer Polinski, Tancy C Zhang, Hannah Bower, Syd Phillips, Yufei Song, Emaan Rashidi, Rafia Bosan, Hsiu-Ching Chang and 15 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 3 pooled it
15.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 3 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Pooled it
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  10. The risk of venous thromboembolism in RA.Rheumatology (Oxford, England) · 2026
    Review
  11. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 9 institutions in 4 countries.

Claudia A SalinasEli Lilly and Company Corporate Center, 893 Delaware St., Indianapolis, IN, 46225, USA. claudia.salinas@lilly.com.
Anthony LouderAetion, New York, NY, USA.
Jennifer PolinskiAetion, New York, NY, USA.
Tancy C ZhangAetion, New York, NY, USA.
Hannah BowerClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Syd PhillipsIQVIA, Epidemiology and Drug Safety, IQVIA, Durham, NC, USA.
Yufei SongIQVIA, Epidemiology and Drug Safety, IQVIA, Durham, NC, USA.
Emaan RashidiIQVIA, Epidemiology and Drug Safety, IQVIA, Durham, NC, USA.
Rafia BosanIQVIA, Epidemiology and Drug Safety, IQVIA, Durham, NC, USA.
Hsiu-Ching ChangIQVIA, Epidemiology and Drug Safety, IQVIA, Durham, NC, USA.
Nicole FosterCorEvitas, Waltham, MA, USA.
Bernice GershensonCorEvitas, Waltham, MA, USA.
Hisashi YamanakaRheumatology, Sanno Medical Center, Tokyo, Japan.
Mitsumasa KishimotoDepartment of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Peter FischerEli Lilly and Company Corporate Center, 893 Delaware St., Indianapolis, IN, 46225, USA.
Baojin ZhuEli Lilly and Company Corporate Center, 893 Delaware St., Indianapolis, IN, 46225, USA.
Douglas FariesEli Lilly and Company Corporate Center, 893 Delaware St., Indianapolis, IN, 46225, USA.
Xiaodan MaiHealthCore Inc., Wilmington, DE, USA.
Brett T DohertyHealthCore Inc., Wilmington, DE, USA.
Angela GrelaudBordeaux PharmacoEpi, INSERM CIC-P 1401, Univ. Bordeaux, Bordeaux, France.
Nicolas H ThurinBordeaux PharmacoEpi, INSERM CIC-P 1401, Univ. Bordeaux, Bordeaux, France.
Johan AsklingClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Walter DeberdtEli Lilly and Company Corporate Center, 893 Delaware St., Indianapolis, IN, 46225, USA.
B023 Study Consortium
Eli Lilly (United States) · USIQVIA (United States) · USAetion (United States) · USKarolinska Institutet · SEUniversité de Bordeaux · FRWilmington University · USKyorin University · JPSanno Medical Center · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this work is to evaluate baricitinib safety with respect to venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and serious infection relative to tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA).

methodsPatients with RA from 14 real-world data sources (three disease registries, eight commercial and three government health insurance claims databases) in the United States (n = 9), Europe (n = 3), and Japan (n = 2) were analyzed using a new user active comparator design. Propensity score matching (1:1) controlled for potential confounding. Meta-analysis of incidence rate ratios (IRR) and incidence rate differences (IRD) for each outcome, from each data source was executed using modified Poisson regression and Cochran-Mantel-Haenszel analysis.

resultsOf 9013 eligible baricitinib-treated patients, 7606 were propensity score-matched with TNFi-treated patients, contributing 5879 and 6512 person-years of baricitinib and TNFi exposure, respectively. Across data sources, 97 patients (56 baricitinib) experienced VTE during follow-up, 93 experienced MACE (54 baricitinib), and 321 experienced serious infection (176 baricitinib). Overall IRRs comparing baricitinib with TNFi treatment were 1.51 (95% CI 1.10, 2.08) for VTE, 1.54 (95% CI 0.93, 2.54) for MACE, and 1.36 (95% CI 0.86, 2.13) for serious infection. IRDs for VTE, MACE, and serious infection, respectively, were 0.26 (95% CI -0.04, 0.57), 0.22 (95% CI -0.07, 0.52), and 0.57 (95% CI -0.07, 1.21) per 100 person-years greater for baricitinib than TNFi.

conclusionsOverall results suggest increased risk of VTE with baricitinib versus TNFi, with consistent point estimates from the two largest data sources. A numerically greater risk was observed for MACE and serious infection when comparing baricitinib versus TNFi, with different point estimates from the two largest data sources. Findings from this study and their impact on clinical practice should be considered in context of limitations and other evidence regarding the safety and efficacy of baricitinib and other Janus kinase inhibitors.

trial registrationEU PAS Register ( http://encepp.eu ), identifier #32271.

Indexed as

BaricitinibJAK inhibitorsMajor adverse cardiovascular eventRheumatoid arthritisSerious infectionTumor necrosis factor inhibitorsVenous thromboembolism

Identifiers

PMID36371760
PMCPMC9660195
OpenAlexW4309047518

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.