P1103 Thromboembolic and cardiovascular risk profiles in ulcerative colitis patients initiating advanced therapies: a single-center study
Authors: Calvez V , Cuccia G , Del Gaudio A , Capobianco I , Parisio L , Gasbarrini A , Scaldaferri F , Carbone L , Pugliese D 
Published: January 2025

Background

IBD, especially during flare periods, seems to be associated with an increased risk of thromboembolic and cardiovascular(CV) events[1]. After the results of the ORAL Surveillance study[2] enrolling patients with rheumatoid arthritis, several concerns have also been raised on the intrinsic risk of Janus kinase inhibitors (JAK-i), though the population enrolled was predominantly &gt;50 years old and had several CV risk factors (CVRF). Accordingly, regulatory agencies recommend that JAK-i should be used only if no suitable treatment alternatives are available in patients at increased CV risk for all indications [3]. However, the real prevalence of CVRF and the risk related to JAK-i seem to be lower for patients with UC. The aim of our study is to explore the prevalence of thromboembolic and CV risks factors in a large cohort of UC patients suitable for advanced therapies.

Methods

We conducted a single-centre study including all consecutive adult patients with UC who initiated advanced therapies between Jun-20 and Dec-23. To assess thrombosis and CV risk, we collected all anamnestic, clinical and laboratory data from the medical records. In addition, we used an online questionnaire to collect all other information that were not available in routine clinical records. To assess CV risk, we calculated the 10-year CV risk score using the American College of Cardiology ASCVD Risk Estimator[4].

Results

Out of 305 patients surveyed, we had a 100% response rate: 53.5% male, with a median age of 44 years. Overall, 39.0% were biologic-naïve, and 21.6% started a Janus kinase inhibitor (JAK-i). Baseline patients’ characteristics and variables collected are shown in Table 1 and Table 2, respectively. Cumulatively, 184 patients (60.3%) had 0-1 thromboembolic risk factors, 73 patients (23.93%) had 2 risk factors, 34 patients (11.2%) had 3 risk factors, 8 patients(2.6%) had 4, and 6 patients(1.9%) had 5 or 6 thromboembolic risk factors.

Complete cholesterol data were available for 171 patients, but ASCVD score has been calculated only for 153 patients(median age 49 years) with LDL-C levels &gt;70 mg/dL. Among them, 67.3% were classified as low risk, 6.5% as borderline risk, 20.9% as intermediate risk, and 5.2% as high risk. When CV risk was stratified by age, 66.7% of elderly patients (aged 65 years or older) were classified as intermediate risk, while 20.8% were high risk. In contrast, 79.1% of non-elderly were categorized as low risk, 12.4% at intermediate risk and 2.3% at high risk.

Conclusion

Our study confirms the prevalence of thrombotic and CVRF among patients affected by UC is quite low and mostly related to age. Accordingly, the concerns regarding the use of JAK-i observed in rheumatological cohorts may not be fully applicable for patients with UC.

References

[1]Fumery M, Xiaocang C, Dauchet L, Gower-Rousseau C, Peyrin-Biroulet L, Colombel J-F. Thromboembolic events and cardiovascular mortality in inflammatory bowel diseases: A meta-analysis of observational studies. Journal of Crohn’s and Colitis 2014;8:469–79. https://doi.org/10.1016/j.crohns.2013.09.021.

[2]Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, et al. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med 2022;386:316–26. https://doi.org/10.1056/NEJMoa2109927.

[3]EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders | European Medicines Agency n.d. https://www.ema.europa.eu/en/news/ema-confirms-measures-minimise-risk-serious-side-effects- janus-kinase-inhibitors-chronic-inflammatory-disorders (accessed April 25, 2024).

[4]Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC, Sperling LS, Virani SS, et al. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease. Journal of the American College of Cardiology 2019;73:3153–67. https://doi.org/10.1016/j.jacc.2018.11.005.