Potential impact of European Medicines Agency measures to minimize risk of serious side effects on JAKi prescribing and utilization in the UK
Authors' conclusion
Four-fifths of RA patients who had commenced a JAKi before the EMA advisory were considered 'at-risk', with prescribing only advised if there was no suitable alternative.
Study context
- Population
- Rheumatoid arthritis (RA) patients starting first-ever JAKi therapy in BSRBR-RA between 13 February 2017 and 31 May 2022, before European Medicines Agency (EMA) risk-minimization measures
- Participants
- 1,341 patients
- Outcome
- Percentage of patients meeting the EMA risk criteria
Methodological detailslarge national cohort (BSRBR-RA)
- Large national cohort (BSRBR-RA)
Main finding
As reported in the abstract
Met ≥1 EMA risk criterion
Patients meeting ≥1 EMA risk criterion (N = 1075)
80%
Observational data: associations, not effects.
Further findings
Prior bDMARD classes among at-risk patients
- JAKi as first or second b/tsDMARD class (529 patients)
- 49%
- ≥3 prior bDMARD classes (299 patients)
- 28%
Original publication
Potential impact of European Medicines Agency measures to minimize risk of serious side effects on JAKi prescribing and utilization in the UK. Rheumatology (Oxford). Published 15 May 2024. doi:10.
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