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BRIEF RESEARCH REPORT article

Front. Immunol.
Sec. Autoimmune and Autoinflammatory Disorders: Autoinflammatory Disorders
Volume 15 - 2024 | doi: 10.3389/fimmu.2024.1445680

Use of Janus kinase inhibitors before and after European Medicines Agency safety recommendations: a retrospective study

Provisionally accepted
Patrick-Pascal Strunz Patrick-Pascal Strunz 1*Linus M. Risser Linus M. Risser 2Matthias Englbrecht Matthias Englbrecht 3Torsten Witte Torsten Witte 2Matthias Fröhlich Matthias Fröhlich 1Marc Schmalzing Marc Schmalzing 1Michael Gernert Michael Gernert 1Sebastian Hueper Sebastian Hueper 4Peter Bartz-Bazzanella Peter Bartz-Bazzanella 5,6,7Cay von der Decken Cay von der Decken 5,6,7,8Kristen Karberg Kristen Karberg 7,9Georg Gauler Georg Gauler 10,7Susanna Spaethling-Mestekemper Susanna Spaethling-Mestekemper 11,7Christoph Kuhn Christoph Kuhn 12,7Wolfgang Vorbrüggen Wolfgang Vorbrüggen 7,8Martin Welcker Martin Welcker 13,7Stefan Kleinert Stefan Kleinert 1,14,7
  • 1 Department of Internal Medicine II, University Hospital of Wuerzburg, Wuerzburg, Germany
  • 2 Hannover Medical School, Hanover, Lower Saxony, Germany
  • 3 Freelance Healthcare Data Scientist, Greven, Germany
  • 4 Praxis für Rheumatologie und Osteologie, Hildesheim, Germany
  • 5 Klinik für Internistische Rheumatologie, Rhein-Maas-Klinikum, Würselen, Germany
  • 6 Medizinisches Versorgungszentrum, Stolberg, Germany
  • 7 RHADAR – RheumaDatenRheport GbR, Planegg, Germany
  • 8 Verein zur Förderung der Rheumatologie e.V., Würselen, Germany
  • 9 Rheumatologisches Versorgungszentrum Steglitz, Berlin, Germany
  • 10 Rheumatology Practice, Osnabrück, Germany
  • 11 Rheumapraxis München, München, Germany
  • 12 Praxis für Rheumatologie, Karlsruhe, Baden-Württemberg, Germany
  • 13 Medizinisches Versorgungszentrum für Rheumatologie Dr. M. Welcker GmbH, Planegg, Germany
  • 14 Praxisgemeinschaft Rheumatologie-Nephrologie, Erlangen, Germany

The final, formatted version of the article will be published soon.

    Background: Safety recommendations for Janus kinase inhibitors (JAKi) issued by the European Medical Agency (EMA) in 2023 could potentially influence treatment patterns for rheumatoid arthritis (RA) drugs, but little is known about the impact of these recommendations in routine clinical care.We retrospectively analyzed the German RHADAR rheumatology database for adult patients with RA and documentation of a new therapy with a JAKi, tumour necrosis factor inhibitor (TNFi), or interleukin-6 receptor inhibitor (IL-6Ri). Data were grouped into half-yearly intervals from quarter (Q)2/2020 to Q3/2023. The period from Q4/2022 to Q1/2023 immediately followed the initial EMA endorsement of Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and Q2/2023-Q3/2023 immediately followed the direct healthcare provider communication (DHPC) containing the new safety JAKi recommendations.Results: Between April 1, 2020 and September 23, 2023, 3008 newly initiated therapies for TNFi (1499 [49.8%]), JAKi (1126 [37.4%]), and ) were documented by the treating physicians. JAKi were increasingly used in the first two halfyear periods (from 29.7% of these therapies in Q2/2020-Q3/2020 to 46.7% in Q2/2021-Q3/2021; odds ratio [OR] 2.08; p<0.001). The proportion of initiated JAKi therapies decreased significantly after the PRAC recommendations (32.9%; OR vs peak 0.56; p=0.001) and the DHPC letter (26.1%; OR vs peak 0.40; p<0.001). JAKi were more likely to be used as >3 rd -line therapy in later time periods.Conclusions: This exploratory study suggests that EMA safety recommendations for JAKi influenced treatment patterns of RA patients who received JAKi in Germany.

    Keywords: Janus kinase inhibitors, Rheumatoid arthritis, Safety, European Medicines Agency, Treatment, Tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors

    Received: 07 Jun 2024; Accepted: 02 Aug 2024.

    Copyright: © 2024 Strunz, Risser, Englbrecht, Witte, Fröhlich, Schmalzing, Gernert, Hueper, Bartz-Bazzanella, von der Decken, Karberg, Gauler, Spaethling-Mestekemper, Kuhn, Vorbrüggen, Welcker and Kleinert. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Patrick-Pascal Strunz, Department of Internal Medicine II, University Hospital of Wuerzburg, Wuerzburg, Germany

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.