Evidence map›Paper›PMID 40121611›Full record

ArticleDrug safety2025

Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database.

Raffaella Di Napoli, Christophe Richez, Cristina Scavone, Allison Singier, Maxime Demourgues, Annamaria Mascolo, Annalisa Capuano, Francesco Salvo

Erratum issuedAbstract read
In one paragraph

Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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.

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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Raffaella Di NapoliCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy. raffaella.dinapoli@unicampania.it.ORCID http://orcid.org/0009-0009-4497-3836
Christophe RichezService de Rhumatologie, Centre de référence des maladies auto-immunes systémiques rares RESO, Hôpital Pellegrin, Centre Hospitalier Universitaire, Bordeaux, France.
Cristina ScavoneCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Allison SingierUniversité de Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team, 33000, Bordeaux, France.
Maxime DemourguesCHU de Bordeaux, Service de Pharmacologie Médicale, Centre Régional de Pharmacovigilance Bordeaux-DROM, 33000, Bordeaux, France.
Annamaria MascoloCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Annalisa CapuanoCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Francesco SalvoUniversité de Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team, 33000, Bordeaux, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRheumatoid arthritis (RA) is commonly treated with Janus kinase inhibitors (JAKis) and anti-tumor necrosis factor-α (anti-TNFα), but the cardiovascular safety profiles of these drugs remain unclear.

objectiveThe aim of this study was to describe the individual case safety reports of major adverse cardiac events (MACE) or stroke and to determine whether there was a difference in the frequency of reporting of cardiovascular events between JAKis and anti-TNFα used in RA.

methodsA case/non-case study was conducted using the WHO VigiBase

resultsA total of 18,099 cases of MACE were identified, of which 2543 (14%) were associated with JAKis, predominantly in women (65.4%) and in patients aged ≥65 years (49.9%). The median time to onset was 210 days (IQR 60-510) for JAKis and 690 days (210-1460) for anti-TNFα. JAKis were associated with higher odds of reporting MACE (ROR 1.38 [95% CI 1.32-1.44]), mainly due to non-fatal stroke (1.65 [1.55-1.75]). Stroke as a whole showed similar results (1.62 [1.53-1.72]). The ROR of MACE was also slightly increased in patients aged <65 years treated with JAKis (1.29 [1.21-1.39]).

conclusionsCompared with anti-TNFα, JAKis were more associated with MACE, especially stroke, and with a shorter time to onset. These data support the hypothesis of a different cardiovascular reporting frequency between JAKis and anti-TNFα. In patients with identified cardiovascular risk, anti-TNFα should be preferred to JAKis until more definitive results are available.

Indexed as

Antirheumatic AgentsCardiovascular DiseasesJanus Kinase InhibitorsAdultAdverse Drug Reaction Reporting SystemsAgedArthritis, RheumatoidDatabases, FactualFemaleHumansMaleMiddle AgedStrokeTumor Necrosis Factor-alphaWorld Health OrganizationAntirheumatic AgentsJanus Kinase InhibitorsTumor Necrosis Factor-alpha

Identifiers

PMID40121611
PMCPMC12259736

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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.