A detailed look at the European Medicines Agency's recommendations for use of Janus kinase inhibitors in patients with atopic dermatitis

Author:

Wollenberg Andreas1ORCID,Thyssen Jacob P.2ORCID,Bieber Thomas3,Chan Gary4,Kerkmann Urs5

Affiliation:

1. Department of Dermatology and Venerology Ludwig Maximillian University Munich Germany

2. Department of Dermatology, Bispebjerg Hospital University of Copenhagen Copenhagen Denmark

3. Department of Dermatology and Allergy University Hospital of Bonn Bonn Germany

4. Pfizer Inc Groton Connecticut USA

5. Pfizer Pharma GmbH Berlin Germany

Abstract

AbstractBackgroundOral Janus kinase inhibitors (JAKi) have been approved for the treatment of several chronic inflammatory conditions, including rheumatoid arthritis (RA) and atopic dermatitis (AD). Prompted by new evidence, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recently reassessed the benefit–risk balance of oral JAKi. The PRAC recommended that oral JAKi should be used only if no suitable alternatives are available in patients ≥65 years of age, or who have a history of atherosclerotic cardiovascular (CV) disease, other CV risk factors (e.g. history of long‐term smoking) or have malignancy risk factors, and used with caution in patients at risk of pulmonary embolism or deep vein thrombosis. The European Commission's final decision was issued in March 2023.ObjectivesOur goal was to highlight the PRAC recommendations, especially in the context of oral JAKi use in AD.MethodsAuthors summarized the PRAC recommendations, the new clinical evidence on oral JAKi safety and key differences between patients with RA and AD.ResultsRisk of developing adverse events of special interest (e.g. cardiovascular events, malignancy) is higher in patients with RA than in patients with AD, because of the higher prevalence of the underlying risk factors.ConclusionsThe benefit–risk profile of JAKi approved for AD remains favourable, including use as first‐line systemic therapy for patients with AD <65 years of age and without CV or malignancy risk factors.

Funder

Pfizer

Publisher

Wiley

Subject

Infectious Diseases,Dermatology

Reference17 articles.

1. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis

2. European Medicines Agency.EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders.2022Available from:https://www.ema.europa.eu/en/news/ema‐recommends‐measures‐minimise‐risk‐serious‐side‐effects‐janus‐kinase‐inhibitors‐chronic[Accessed 28th October 2022].

3. BuchMH BhattDL Charles‐SchoemanC GilesJT MikulsTR KochG et al.Risk of extended major adverse cardiovascular event endpoints with tofacitinib vs TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomized safety study. American College of Rheumatology (ACR) Convergence 2022; November 10–14 2022.

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