Evidence map›Paper›PMID 36802049›Full record

Trial reportAdvances in therapy2023

Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications.

Peter C Taylor, Thomas Bieber, Rieke Alten, Torsten Witte, James Galloway, Walter Deberdt, Maher Issa, Ewa Haladyj, Inmaculada De La Torre, Susanne Grond and 1 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2023. 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 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
9.2field-weighted citation impact, top 2% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Guideline
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. OX40 in the Pathogenesis of Atopic Dermatitis-A New Therapeutic Target.American journal of clinical dermatology · 2024
    Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Baricitinib triggering a central nervous system inflammatory-demyelinating disease: A case report.Multiple sclerosis journal - experimental, translational and clinical
    Article
  19. Review
  20. Association of Venous Thromboembolism Risk with Atopic Dermatitis and Janus Kinase Inhibitors Treatment: A Mendelian Randomization Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 5 countries.

Peter C TaylorThe Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK. peter.taylor@kennedy.ox.ac.uk.ORCID http://orcid.org/0000-0001-7766-6167
Thomas BieberDepartment of Dermatology and Allergy, University of Bonn, Bonn, Germany.
Rieke AltenDepartment of Internal Medicine and Rheumatology, Schlosspark-Klinik Charité, University Medicine Berlin, Berlin, Germany.
Torsten WitteClinical Immunology, Hannover Medical School, Hannover, Germany.
James GallowayCentre for Rheumatic Diseases, King's College London, London, UK.
Walter DeberdtEli Lilly and Company, Indianapolis, IN, USA.
Maher IssaEli Lilly and Company, Indianapolis, IN, USA.
Ewa HaladyjEli Lilly and Company, Indianapolis, IN, USA.
Inmaculada De La TorreEli Lilly and Company, Indianapolis, IN, USA.
Susanne GrondEli Lilly and Company, Indianapolis, IN, USA.
Andreas WollenbergDepartment of Dermatology and Allergology, Ludwig Maximilian University of Munich, Munich, Germany.
Eli Lilly (United States) · USKing's College London · GBMedizinische Hochschule Hannover · DENuffield Orthopaedic Centre · GBSchlosspark-Klinik · DEUniversity of Bonn · DEVrije Universiteit Brussel · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBaricitinib, a Janus kinase (JAK) 1/2 inhibitor, is an approved treatment for rheumatoid arthritis (RA), atopic dermatitis (AD), and alopecia areata (AA). Further characterisation of adverse events of special interest (AESI) for JAK inhibitors in at-risk populations will improve benefit-risk assessment for individual patients and diseases.

methodsData were pooled from clinical trials and long-term extensions in moderate-to-severe active RA, moderate-to-severe AD, and severe AA. Incidence rates (IR) per 100 patient-years of major adverse cardiovascular event (MACE), malignancy, venous thromboembolism (VTE), serious infection, and mortality were calculated for patients with low risk (younger than 65 years with no specified risk factors), and patients at risk (≥ 1 of: aged 65 years or older, atherosclerotic cardiovascular disease, diabetes mellitus, hypertension, current smoking, HDL cholesterol < 40 mg/dL, BMI ≥ 30 kg/m

resultsDatasets included baricitinib exposure up to 9.3 years with 14,744 person-years of exposure (PYE) (RA), 3.9 years with 4628 PYE (AD), and 3.1 years with 1868 PYE (AA). In patients with low risk (RA: 31%, AD: 48%, AA: 49%), IRs for MACE (0.05, 0.04, 0), malignancies (0.20, 0.13, 0), VTE (0.09, 0.04, 0), serious infection (1.73, 1.18, 0.6), and mortality (0.04, 0, 0) in the RA, AD, and AA datasets, respectively, were low. In patients at risk (RA: 69%, AD: 52%, AA: 51%), IRs were for MACE (0.70, 0.25, 0.10), malignancies (1.23, 0.45, 0.31), VTE (0.66, 0.12, 0.10), serious infection (2.95, 2.30, 1.05), and mortality (0.78, 0.16, 0) for RA, AD, and AA datasets, respectively.

conclusionPopulations with low risk have low incidence of the examined JAK inhibitor-related AESI. In the dermatologic indications, incidence is also low for patients at risk. Considering individual disease burden, risk factors, and response to treatment is relevant to make informed decisions for individual patients treated with baricitinib.

Indexed as

Arthritis, RheumatoidAzetidinesJanus Kinase InhibitorsVenous ThromboembolismHumansPurinesPyrazolesRisk FactorsSulfonamidesAzetidinesbaricitinibJanus Kinase InhibitorsPurinesPyrazolesSulfonamidesAdverse eventsBaricitinibJAK inhibitorsMACEMalignancyMortalitySafetySerious infectionVTE

Identifiers

PMID36802049
PMCPMC9939375
OpenAlexW4321478309

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.