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DDW 2024 Preview丨5W+ data confirm that treatment with biologics and oral small molecule drugs in elderly IBD patients does not increase the risk of MACE or VTE

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DDW 2024 Preview丨5W+ data confirm that treatment with biologics and oral small molecule drugs in elderly IBD patients does not increase the risk of MACE or VTE

Inflammatory bowel disease (IBD) is a chronic recurrent intestinal and systemic inflammatory disease in which biologics and oral small molecule drugs (OSMs) have a clear response to IBD, although some of these drugs may increase the risk of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE), especially in older patients with IBD.

Digestive Disease Week in America (DDW 2024) will be held in Washington, D.C., May 18-21. Scholars from the United States have studied the risk of MACE and VTE in elderly IBD patients receiving biologics or OSM treatment.

DDW 2024 Preview丨5W+ data confirm that treatment with biologics and oral small molecule drugs in elderly IBD patients does not increase the risk of MACE or VTE

01Research Methods

The TrinNetX multi-agency database was used to investigate the incidence of MACE and VTE in older patients (aged >50 years) who received biologics (infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab, or ustekinumab) and compared them with IBD patients who did not receive biologics. In addition, data were identified for the treatment of older IBD patients treated with OSM (tofacitinib, upadatinib, or ozanimod) and compared with those who did not receive OSM. Subgroup analyses were performed for older IBD patients with at least one cardiovascular (CV) risk factor and treated with JAKi (tofacitinib or upadatinib) alone. A 1:1 match was performed using a propensity score matching method, with covariates including age, ethnicity, sex, cardiovascular risk factors, and IBD-related medications. The duration of the assessment is at least 30 days to 3 years after the drug is prescribed.

02 Research results

The study included 27,292 older IBD patients with and without biologics, and 2,015 with and without OSM.

Oral small molecule drugs

There was no increased risk of myocardial infarction (MI) (aOR 0.83, 95% CI 0.49, 1.39), stroke (aOR 0.79, 95% CI 0.46, 1.35), or VTE (aOR 0.90, 95% CI 0.63, 1.29) in patients treated with OSM compared with older patients with IBD who did not receive OSM.

Subgroup analyses of patients with at least one cardiovascular risk factor showed no increased risk of myocardial infarction, stroke, or VTE in older IBD patients treated with OSM. Notably, the risk of all-cause mortality was reduced in older patients with IBD treated with OSM (aOR 0.58, 95% CI 0.42, 0.81).

Table 1: Analysis of outcomes of > 50-year-old IBD patients treated with OSM

DDW 2024 Preview丨5W+ data confirm that treatment with biologics and oral small molecule drugs in elderly IBD patients does not increase the risk of MACE or VTE

Similarly, an increased risk of myocardial infarction, stroke, or VTE was not found in older IBD patients treated with JAKi, even in patients with at least one cardiovascular risk factor.

Table 1 (continued): Analysis of outcomes of > 50-year-old IBD patients treated with OSM

DDW 2024 Preview丨5W+ data confirm that treatment with biologics and oral small molecule drugs in elderly IBD patients does not increase the risk of MACE or VTE

Biologics

Older IBD patients taking biologics had a lower risk of myocardial infarction (aOR 0.8, 95% CI 0.69, 0.91), stroke (aOR 0.75, 95% CI 0.65, 0.87), and all-cause death (aOR 0.57, 95% CI 0.52, 0.62), and no difference in VTE (aOR 0.96, 95% CI 0.87, 1.06) compared with older patients with IBD who were not treated with biologics;

Subgroup analyses of patients with at least one cardiovascular risk factor showed a reduced risk of stroke and all-cause mortality and no difference in the risk of VTE or myocardial infarction in older IBD patients taking biologics compared with older IBD patients who did not receive biologic agents.

Table 2: Outcomes of 50-year-old IBD patients > after propensity score matching to receive biologic preparations

DDW 2024 Preview丨5W+ data confirm that treatment with biologics and oral small molecule drugs in elderly IBD patients does not increase the risk of MACE or VTE

03 Conclusions of the study

Treatment with biologics or OSM in older IBD patients does not increase the risk of MACE or VTE, providing further support for the safety aspects of these drugs (biologics and small molecule drugs) in the treatment of older IBD patients.

source

BIOLOGICS AND ORAL SMALL MOLECULES ARE NOT ASSOCIATED WITH INCREASED MAJOR ADVERSE CARDIOVASCULAR EVENTS OR VENOUS THROMBOEMBOLISM IN OLDER IBD PATIENTS. DDW 2024. Presentation Number: Sa1743.

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