Evidence map›Paper›PMID 35504889›Full record

Observational studyScientific reports2022

Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database.

Léa Hoisnard, Bénédicte Lebrun-Vignes, Sébastien Maury, Matthieu Mahevas, Khalil El Karoui, Lydia Roy, Anissa Zarour, Marc Michel, José L Cohen, Aurélien Amiot and 4 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 94 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 1 pooled it
22.7field-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

94 citing papers in PubMed, 1 synthesis or guideline pooled it, 153 citations in OpenAlex.

  1. Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
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34 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

14 authors at 5 institutions in 1 country.

Léa HoisnardFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France. lea.hoisnard@aphp.fr.
Bénédicte Lebrun-VignesDepartment of Pharmacology, Pharmacovigilance Unit, Assistance Publique-Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Paris, France.
Sébastien MauryFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Matthieu MahevasFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Khalil El KarouiFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Lydia RoyHematology Department, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital & Faculté de Santé, UPEC (Université Paris Est Créteil), 94010, Créteil, France.
Anissa ZarourFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Marc MichelFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
José L CohenFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Aurélien AmiotFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Pascal ClaudepierreFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Pierre WolkensteinFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Philippe GrimbertFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Emilie SbidianFédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, 94010, Créteil, France.
Assistance Publique – Hôpitaux de Paris · FRFédération Hospitalo-Universitaire, Paris Center for Microbiome Medicine · FRHôpitaux Universitaires Henri-Mondor · FRInstitut Mondor de Recherche Biomédicale · FRUniversité Paris-Est Créteil · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Increasing number of Janus kinase (JAK) inhibitors have been approved for chronic haematopoietic neoplasms and inflammatory/autoimmune diseases. We aimed to assess safety of the first three approved JAK inhibitors: ruxolitinib, tofacitinib and baricitinib. In this retrospective observational study, pharmacovigilance data were extracted from the World Health Organization database. Adverse events are classified according to Medical Dictionary for Regulatory Activities hierarchy. Until February 28, 2021, all Individual Case Safety Reports [ICSRs] with the suspected drug ruxolitinib, tofacitinib or baricitinib were included. Disproportionality analysis was performed and the information component (IC) was estimated. Adverse events were considered a significant signal if the lower end of the 95% credibility interval of the IC (IC025) was positive. We identified 126,815 ICSRs involving JAK inhibitors. Ruxolitinib, tofacitinib and baricitinib were associated with infectious adverse events (IC025 1.7, especially with viral [herpes and influenza], fungal, and mycobacterial infectious disorders); musculoskeletal and connective tissue disorders (IC025 1.1); embolism and thrombosis (IC025 0.4); and neoplasms (IC025 0.8, especially malignant skin neoplasms). Tofacitinib was associated with gastrointestinal perforation events (IC025 1.5). We did not find a significant increase in the reporting of major cardiovascular events. We identified significant association between adverse events and ruxolitinib, tofacinitib and baricitinib in international pharmacovigilance database.

Indexed as

Autoimmune DiseasesJanus Kinase InhibitorsDatabases, FactualHumansPharmacovigilanceWorld Health OrganizationJanus Kinase Inhibitors

Identifiers

PMID35504889
PMCPMC9065106
OpenAlexW4225416290

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.