AB0463 THE IMPACT OF PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC) RECOMMENDATIONS ON THE REAL-LIFE USE OF JANUS KINASES INHIBITORS FOR RHEUMATOID ARTHRITIS

Background In November 2022 the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended measures to minimize risk of serious adverse events associated with use Janus kinase inhibitors (JAKis). Objectives The aim study was evaluate in a real-life cohort impact PRAC recommendations on JAKis for treatment patients rheumatoid arthritis (RA) and describe their clinical characteristics. rate JAKi discontinuation because major cardiovascular (CV) (MACE), venous thromboembolism (VTE), or cancer also analyzed according limitations. Methods We conducted retrospective analysis RA treated from single-centre, tertiary care hospital. population stratified into eligible not accordance indications. considered as ineligible: >65 years old; current former long-term smokers; carrying increased MACE (defined ORAL SURVEILLANCE trial [1] inclusion criteria [>50 old having at least one CV factor]), VTE (according International Society Thrombosis Haemostasis categorization [2] ), previous history malignancy). ineligible group, descriptive individual reasons contraindication conducted. An performed whole over mean follow-up period 20.9 months. Results Of 194 enrolled, 114 (57.9%) were classified definition (n=39 [34.2%] n=80 [70.2%] MACE; n=35 [30.7%] n=23 [20.2%] VTE, n=8 [7.0%] As detailed Table 1, 52 (45.6%) fulfilled only one, 49 (43.0%) two, 13 (11.4%) three more criteria. Among single factor, this high 42.3% cases. Compared ones, often obese (18.4% vs 0%; p <0,001), had higher disease duration (15 12 years; =0.01), therapy (17.5 10 months; p=0.02), HAQ score (1 0.125; <0.001), prevalence arterial hypertension (43% 12.5%; non-ischaemic heart (13.2% 3.8%; =0.03), hyperlipidemia (53.5% diabetes (7.9% 1,3%; p=0.04). due similar (5.0%) non-eligible (7.0%) (p=0.57). observed two withdrawals withdrawal non-fatal stroke solid malignancy (all group). Conclusion Our shows that rigorous application setting would result large proportion being excluded JAKis, apparently without consequent significant reduction events. A better quantification MACE, is advocated improve our decision-making process management RA. References Ytterberg SR, et al. N Engl J Med 27;386(4):316-326. Kearon C, Thromb Haemost 2016;14:1480–83. 1. Classification recommendationsPRAC, Committee; 1 factor ineligibles (N=52 ) N. Current Smoking 9 Thrombophilia History 2 Age > 65 22 factors (N=49 + 18 7 smoking 19 3 (N=13 thrombosis 5 65% Acknowledgements thank physicians who participated study. Disclosure Interests Ennio Giulio Favalli Speakers bureau: AbbVie, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Consultant of: Matteo Ferrito: None declared, Raffaele Di Taranto: Martina Biggioggero Francesco Orsini: Sabino Germinario: Gilberto Cincinelli: Roberto Caporali Amgen, Fresenius, UCB.