Evidence map›Paper›PMID 36130766›Full record

ArticleBMJ open2022

Oral Janus kinase inhibitors and venous thromboembolic events in atopic dermatitis: protocols for a case-time control study and a nested case-control study based on the French national health insurance (SNDS) cohort.

Pauline Berthe, Lucie-Marie Scailteux, Alain Lescoat, Delphine Staumont, Guillaume Coiffier, Pierre Guéret, Alain Dupuy, Emmanuel Oger, Catherine Droitcourt

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
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  4. Article
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

9 authors at 3 institutions in 2 countries.

Pauline BertheDepartment of Dermatology, CHU Rennes, Rennes, France pauline.berthe@chu-rennes.fr.ORCID 0000-0001-9335-5799
Lucie-Marie ScailteuxPharmacovigilance and Pharmacoepidemiology, CHU Rennes, Rennes, France.ORCID 0000-0001-7047-9107
Alain LescoatUniv Rennes, INSERM, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, Rennes, France.ORCID 0000-0003-2081-8558
Delphine StaumontDepartment of Dermatology, Lille University Hospital Center, Lille, France.
Guillaume CoiffierDepartment of Rheumatology, CH Dinan, Dinan, France.
Pierre GuéretHaemostasis Department, CHU Rennes, Rennes, France.
Alain DupuyDepartment of Dermatology, CHU Rennes, Rennes, France.
Emmanuel OgerPharmacovigilance and Pharmacoepidemiology, CHU Rennes, Rennes, France.
Catherine DroitcourtDepartment of Dermatology, CHU Rennes, Rennes, France.
Inserm · FRCentre Hospitalier Universitaire de Rennes · FRUniversité de Lille · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAtopic dermatitis (AD) is a highly prevalent, chronic, inflammatory skin disease. Several orally administered Janus kinase inhibitors (JAKis, including baricitinib, upadacitinib and abrocitinib) have received a marketing authorisation for AD.Clinical trials in rheumatoid arthritis (RA) have flagged up a potential risk of JAKi-induced venous thromboembolic events (VTEs). Accordingly, the summary of product characteristics for a JAKi must mention VTEs as potential adverse drug reactions. In contrast to RA, AD per se is not associated with an elevated risk of VTEs. Assessing this potential risk among patients with AD would shed further light on the putative underlying relationship between JAKis and VTEs.Our research question is to investigate whether JAKi administration increases the risk of VTEs in adults with AD. Our primary objective is to assess the risk of VTEs in adults with AD exposed to JAKis compared to AD adults not exposed to JAKis, and our secondary objective is to evaluate whether JAKi initiation acts as a trigger of VTEs in adults with AD within 3 months. METHODS AND ANALYSIS: Hence, we have designed (1) a nested case-control study and (2) a case-time control study in a cohort of adults with AD with data from the French national health insurance system (2017-2025).Here, we describe the study protocol, our methodological choices and certain novel aspects, including the combined value of the two assumptions and the use of an exhaustive national health insurance database with potentially greater statistical power for studying rare events in the population of patients with AD at a low risk of VTEs (thus limiting the influence of confounding factors). ETHICS AND DISSEMINATION: The protocol has been approved by an independent ethics committee and registered with the French National Data Protection Commission. The study's findings will be published in peer-reviewed scientific journals and presented at international conferences.

Indexed as

Arthritis, RheumatoidDermatitis, AtopicJanus Kinase InhibitorsVenous ThromboembolismVenous ThrombosisAdultCase-Control StudiesHumansNational Health ProgramsJanus Kinase InhibitorsAdult dermatologyCLINICAL PHARMACOLOGYEczemaRisk managementThromboembolism

Identifiers

PMID36130766
PMCPMC9494565
OpenAlexW4296564657

What OpenQuestion holds

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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.