Background:The European Medicine Agency (EMA) identified measures to minimize the risk of serious side effects with Janus kinase inhibitors (JAKi) for chronic inflammatory disorders. Their prescription must be considered only if no suitable therapeutic alternatives are available in patients aged 65 years or older, in those at increased risk of major cardiovascular (CV) events (MACE), in current or former smokers, and in those at increased risk of cancer [1]. Estimating 10-year CV risk by validated algorithms may be a valid option to evaluate JAKi therapy eligibility in these patients. However, the actual suitability of the 10-year CV risk estimate concerning adherence to EMA guidelines has not been established.Objectives:To assess how the eligibility for JAKi therapy according to EMA guidelines varies depending on whether the physician considers the presence of at least one CV risk factor or estimates the individual CV risk according to the European Society of Cardiology (ESC) algorithm in a cohort of rheumatoid arthritis (RA) patients aged both over and under 65 years.Methods:A cross-sectional cohort of RA patients, fulfilling the ACR/EULAR classification criteria and registered in a multicentre Italian database, was evaluated. All included patients were free from previous CV events and had available variables for 10-year CV risk estimation by SCORE-2 or SCORE-2 OP algorithms [2], multiplied according to EULAR recommendations by 1.5 [3]. All traditional CV risk factors were recorded at inclusion. According to the SCORE charts, patients with an individual estimated 10-year CV risk >7.5%, >10%, or >15% if aged up to 50 years, between 50 and 69 years, or ≥70 years, respectively, were considered at high CV risk.Results:Data on 1140 RA patients [78.7% female; mean age 60±11 years; 411 (36%) patients were ≥ 65 years; median disease duration of 120 (95%CI 114-120) months] were available for analysis. Among traditional CV risk factors, 837 (73.4%) patients had dyslipidemia, 579 (50.8%) hypertension, 476 (41.7%) were overweight, 219 (19.2%) obese, 301 (26.4%) were smokers and 145 (12.7%) had diabetes mellitus. Of note, 379 (92.2%) RA patients aged ≥ 65 years old had at least one traditional CV risk factor and would not be candidates for JAKi therapy according to EMA indications. Stratifying patients according to the 10-year CV risk, 6/180 (3.3%) of patients < 50 years, 108/745 (14.5%) aged 50-69 years and 117/215 (54.4%) > 70 years were at high CV risk. Compared to the consideration of a single traditional CV risk factor if older than 65 years, a significantly lower percentage of RA patients (20.3%, p<0.0001), even considering those younger than 65 years, would not be eligible for JAKi therapy, given their high CV risk according to the SCORE-2.Conclusion:Our study shows that, if a single traditional CV risk factor is considered, more than 90% of RA patients aged ≥ 65 years would not be eligible for JAKi therapy. Whereas individual CV risk stratification according to ESC guidelines reduces the percentage of patients at high CV risk to about 20%, even considering younger patients. Post-hoc analyses of the ORAL Surveillance study showed that patients with previous CV events or a 10-year CV risk >20% had the highest risk of MACE [4]. The CV risk stratification may be considered an appropriate tool to identify patients at higher CV risk in clinical practice and therefore to be candidates for JAKi therapy only if no suitable therapeutic alternatives are available, as the EMA recommends.REFERENCES:[1] European Medicines Agency. Janus kinase inhibitors (JAKi); 2023. Available from: https://www.ema.europa.eu/en/medicines/human/referrals/janus-kinase-inhibitors-jaki[2] SCORE2 working group and ESC Cardiovascular risk collaboration. Eur Heart J 2021; 42:2439-54.[3] Agca R, et al. Ann Rheum Dis. 2017; 76: 17-28.[4] Szekanecz Z, et al Ann Rheum Dis 81:278.Acknowledgements:NIL.Disclosure of Interests:Fabio Cacciapaglia speaker at congresses for Abbvie, Eli Lilly, Galapagos, consultant for Galapagos, Fabiola A...

POS0656 INDIVIDUAL CV RISK ESTIMATION TO EVALUATE ELIGIBILITY FOR JAKi THERAPY: DATA FROM THE CARDIOVASCULAR OBESITY AND RHEUMATIC DISEASES STUDY GROUP OF THE ITALIAN SOCIETY OF RHEUMATOLOGY

10.1136/annrheumdis-2024-eular.2681