Evolution of Janus Kinase inhibitors (JAKi) prescriptions since 2015 in an international collaboration of rheumatoid arthritis registers (the ‘JAK-pot’ study): effect of regulatory warnings
Authors' conclusion
Regulatory safety communications significantly influenced real-world JAKi prescribing patterns. Tofacitinib was most affected through both declines in initiation and increases in discontinuation.
Study context
- Population
- Adult rheumatoid arthritis (RA) patients in 12 national registries, 2015–2024
- Participants
- 55,365 treatment courses
- Exposure
- JAKi prescribing patterns before vs after eight major regulatory safety events
- JAKin = 12,559
- Other bDMARDsn = 42,806reference
- Outcome
- Initiation, discontinuation and switching patterns of JAKi around major regulatory safety warnings
Methodological detailsinterrupted time-series analysis of 12 national RA registers, multinational registry-based, segmented regression, logistic generalized estimating equations (GEE), adjusted for demographic, disease and treatment variables, sensitivity and subgroup analyses
- Interrupted time-series analysis of 12 national RA registers
- Multinational registry-based
- Segmented regression
- Logistic GEE, adjusted for demographic, disease and treatment variables
- Sensitivity and subgroup analyses
Main finding
As reported in the abstract
JAKi initiation and discontinuation trends around regulatory warnings
JAKi use rose, with slowdowns after the 2019 FDA and 2022 EMA warnings
<1 % in 2015 to >20 % by 2024
Observational data: associations, not effects.
Further findings
JAKi discontinuation in at-risk population (age ≥65 with cardiovascular risk factors) (subgroup)
- Rate of JAKi discontinuation significantly rose after the 2019 EMA warning
Original publication
Evolution of Janus Kinase inhibitors (JAKi) prescriptions since 2015 in an international collaboration of rheumatoid arthritis registers (the ‘JAK-pot’ study): effect of regulatory warnings. Semin Arthritis Rheum. Published 12 February 2026. doi:10.
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