ArticleFrontiers in immunology2024
Use of Janus kinase inhibitors before and after European Medicines Agency safety recommendations: a retrospective study.
Article in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- [Update: DMARDs for MGUS].Zeitschrift fur Rheumatologie · 2026Article
- The Impact of PRAC EMA/AIFA Recommendations on the Prescriptions of JAKi and b-DMARDs: Preliminary Results of the Survey from 21 Rheumatological Italian Centers Affiliated with CReI.Journal of personalized medicine · 2026Article
- [Renewed increase in new Janus kinase inhibitor prescriptions : Analysis of the German RHADAR registry].Zeitschrift fur Rheumatologie · 2026Article
- Frailty and cardiovascular safety of JAK inhibitors versus TNF inhibitors in rheumatoid arthritis: a real-world comparative study of drug effects and patient profiles.Frontiers in pharmacology · 2025Article
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Authors and funding
17 authors.
Funding
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Abstract
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. Methods: We retrospectively analyzed the German RHADAR rheumatology database for adult patients with RA and documentation of a new therapy with a JAKi, tumor 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 IL-6Ri (383 [12.7%]) were documented by the treating physicians. JAKi were increasingly used in the first two half-year 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 Conclusions: This exploratory study suggests that EMA safety recommendations for JAKi influenced treatment patterns of RA patients who received JAKi in Germany. Additional studies will be needed to confirm these findings.
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