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.

Objective

To evaluate the impact of recommendations issued by the Pharmacovigilance Risk Assessment Committee (PRAC) and endorsed by the European Medicines Agency (EMA) and the Italian Medicines Agency (AIFA) on rheumatologists' prescribing patterns of Janus kinase inhibitors (JAK inhibitors) and biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA), within a personalized, risk-adapted care framework.

Methods

A brief survey was conducted across 21 Italian rheumatology centers. This retrospective multicenter study included 4421 RA patients assessed before PRAC recommendations (1 January 2022-1 January 2023) and 4376 patients evaluated afterward (2 January 2023-1 January 2024). Prescribing behaviors, cardiovascular risk management, and clinical outcomes were compared between cohorts.

Results

Following PRAC recommendations, a more individualized cardiovascular risk management strategy was observed, with increased use of targeted treatments for hypercholesterolemia, hypertension, and diabetes. The post-PRAC cohort showed a significant reduction in myocardial infarction incidence (0.90% vs. 0.47%; p = 0.02) and increased statin use (8.25% vs. 11.1%; p = 0.05). No increase in cardiovascular risk was observed among JAK inhibitor users. Notably, upadacitinib utilization remained stable despite regulatory restrictions.

Conclusions

PRAC recommendations promoted safer prescribing practices and improved cardiovascular risk stratification in RA. These findings support a shift toward precision medicine, integrating real-world evidence with advanced diagnostic and decision-support tools, including future artificial intelligence-based approaches, to optimize personalized therapeutic strategies in autoimmune diseases.