Potential impact of European Medicines Agency measures to minimize risk of serious side effects on JAKi prescribing and utilization in the UK.

Abstract

Objective: Janus kinase inhibitors (JAKis) or targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) effectively treat rheumatoid arthritis (RA). However, due to safety concerns, the European Medicines Agency (EMA) published risk-minimization measures limiting JAKi prescription to certain at-risk patients unless no suitable alternative is available. This analysis included patients who had started their first-ever JAKi (before EMA measures were published) in a large national cohort study to investigate the potential impact of these measures on JAKi prescribing and utilization in the UK.

Method: RA patients starting first-ever JAKi therapy in BSRBR-RA between 13 February 2017 and 31 May 2022 were included. The percentages of patients meeting the EMA risk criteria were presented. For the at-risk patients, their previous numbers of distinct biologic (b) DMARD classes prescribed were described.

Result: A total of 1341 patients were included, and 80% (N = 1075) met ≥1 EMA risk criterion. Of those who met ≥1 risk criterion, 529 patients (49%) had received JAKi as their first or second b/tsDMARD class, whereas 299 (28%) had received ≥3 prior bDMARD classes.

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. Almost a third of those patients had already received ≥3 bDMARDs classes, and alternative therapies would be very limited for them; however, suitable alternatives might have existed for the remaining proportion, especially for those who received a JAKi as their first or second b/tsDMARD, and re-evaluation of the suitability of their treatment may be needed.