Background <p>Regulatory safety recommendations regarding Janus kinase inhibitors (JAKi) led to a&#xa0;marked decline in new prescriptions in Germany. In the meantime, professional medical societies have also issued differentiated recommendations.</p> Objectives <p>The aim was to investigate the RHADAR (RheumaDatenRhePort) registry to check whether JAKi prescriptions recovered thereafter.</p> Materials and methods <p>A&#xa0;retrospective analysis of new prescriptions for JAKi, tumor necrosis factor inhibitors (TNFi), and interleukin‑6 receptor inhibitors (IL-6Ri) in patients with rheumatoid arthritis between 1&#xa0;April&#xa0;2020, and 30&#xa0;September 2024. The primary endpoint was the proportion of JAKi among all new prescriptions of these three drug classes per half-year. The treatment line of JAKi use was additionally assessed.</p> Results <p>A&#xa0;total of 3492 treatment initiations were recorded in the registry during the observation period (TNFi: <i>n</i> = 1770, 50.7%, JAKi: <i>n</i> = 1269, 36.3%, IL-6Ri: <i>n</i> = 453, 13.0%). The proportion of JAKi initially rose from 29.5% (Q2–Q3/2020) to 46.9% (Q2–Q3/2021), followed by a&#xa0;decline to 24.4% (Q2–Q3/2023) after the regulatory safety communications. Since Q4/2023, a&#xa0;renewed increase has been observed (32.8%), though not yet reaching previous peak levels. JAKi were increasingly shifted from early to advanced treatment lines (≥ 3rd&#xa0;line).</p> Conclusion <p>Following the decline in JAKi prescriptions due to European Medicines Agency safety recommendations, a&#xa0;renewed increase has been observed. Since then, JAKi have been predominantly used in later treatment lines, indicating a&#xa0;more differentiated approach to this drug class.</p>

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Wiederanstieg der Januskinaseinhibitor-Neuverordnungen

  • Patrick-Pascal Strunz,
  • Linus Maximilian Risser,
  • Matthias Englbrecht,
  • Torsten Witte,
  • Matthias Fröhlich,
  • Marc Schmalzing,
  • Michael Gernert,
  • Johannes Heck,
  • Peter Bartz-Bazzanella,
  • Cay von der Decken,
  • Kirsten Karberg,
  • Georg Gauler,
  • Susanna Späthling-Mestekemper,
  • Christoph Kuhn,
  • Wolfgang Vorbrüggen,
  • Martin Welcker,
  • Stefan Kleinert

摘要

Background

Regulatory safety recommendations regarding Janus kinase inhibitors (JAKi) led to a marked decline in new prescriptions in Germany. In the meantime, professional medical societies have also issued differentiated recommendations.

Objectives

The aim was to investigate the RHADAR (RheumaDatenRhePort) registry to check whether JAKi prescriptions recovered thereafter.

Materials and methods

A retrospective analysis of new prescriptions for JAKi, tumor necrosis factor inhibitors (TNFi), and interleukin‑6 receptor inhibitors (IL-6Ri) in patients with rheumatoid arthritis between 1 April 2020, and 30 September 2024. The primary endpoint was the proportion of JAKi among all new prescriptions of these three drug classes per half-year. The treatment line of JAKi use was additionally assessed.

Results

A total of 3492 treatment initiations were recorded in the registry during the observation period (TNFi: n = 1770, 50.7%, JAKi: n = 1269, 36.3%, IL-6Ri: n = 453, 13.0%). The proportion of JAKi initially rose from 29.5% (Q2–Q3/2020) to 46.9% (Q2–Q3/2021), followed by a decline to 24.4% (Q2–Q3/2023) after the regulatory safety communications. Since Q4/2023, a renewed increase has been observed (32.8%), though not yet reaching previous peak levels. JAKi were increasingly shifted from early to advanced treatment lines (≥ 3rd line).

Conclusion

Following the decline in JAKi prescriptions due to European Medicines Agency safety recommendations, a renewed increase has been observed. Since then, JAKi have been predominantly used in later treatment lines, indicating a more differentiated approach to this drug class.