Immune-Mediated Diseases May Increase Risk for Thromboembolic Events


A higher proportion of patients with immune-mediated diseases experienced ≥1 thromboembolic events at baseline compared to those without an IMD.

atopic dermatitis

A study finds that patients with immune-mediated diseases (IMD) are at increased risk for thromboembolic events. Investigators further characterized the risk for such events, noting various modifiable and non-modifiable risk factors.

Diseases included in the analysis were ankylosing spondylitis, atopic dermatitis, inflammatory bowel disease, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and systemic lupus erythematosus.

Spearheaded by Juliana Setyawan, PharmD, of Arena Pharmaceuticals, a team of investigators used an administrative claims database to identify patients diagnosed with one or more of the aforementioned conditions.

Because of potential increase in coagulation and anti-coagulation for these patients, individuals may experience a thromboembolic event, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, and ischemic stroke.

“Given the detrimental impact of thromboembolic events among individuals with IMDs, there is an increasing impetus among health care stakeholders to better understand and quantify the risk of TEs in this patient population,” Setyawan and colleagues wrote.

Characterizing Risk for Thromboembolic Events

The investigators grouped patients with and without IMDs into separate cohorts, each comprising 182,431 individuals. Patients were then matched 1:1 according to age, sex, and index date.

For each cohort, Setyawan and team assessed incremental risk for venous and arterial thromboembolic events, identified according to ICD-9-CM and/or ICD-10-CM codes. They calculated overall and separate incidence rates as number of events divided by patient-years during the study period.

Risk factors for any or more thromboembolic events were evaluated using multivariable regressions, which were performed for deep vein thrombosis, pulmonary embolism, myocardial infarction, and ischemia stroke.


The mean age of the age-matched cohorts was 51.3 years, with majority (64.3%) being female.

The most common IMDs were rheumatoid arthritis (25.9%), psoriasis (24.9%), and inflammatory bowel disease (19.0%).

Further, a higher proportion of patients in the IMD cohort had ≥1 baseline thromboembolic events (4.1%) versus those in the non-IMD cohort (vs 2.7%; P < .0001).

“The IMD cohort had a 1.80 (95% CI, 1.68–1.92; P<.0001) times higher rate of thromboembolic events versus patients in the non-IMD cohort,” the investigators reported. “After adjustments, patients in the IMD cohort had a 1.49 (95% CI, 1.40–1.59; P<.0001) times higher rate of thromboembolic events versus patients in the non-IMD cohort.”

This trend was similar for individual events: deep vein thrombosis aIRR = 1.78), pulmonary embolism (aIRR = 1.66), myocardial infarction (aIRR = 1.17), and ischemic stroke (aIRR = 1.35; all P<.05).

Patients with IMDs also had higher rates of comorbidities and conditions of interest, such as cardiovascular diseases, type 2 diabetes, and peripheral vascular disease — which, in turn, were associated with increased rates of myocardian infaction (IRR  =  2.60, 1.30, and 1.54, respectively; all P<.05) and ischemic stroke (IRR  =  1.53, 1.54, and 1.24, respectively; all P<.05).

Each increasing year of age was also linked to higher risk for all types of events.

Furthermore, use of janus kinase (JAK) inhibitors was associated with an increased rate of pulmonary embolism (IRR = 2.52; P<0.05), as well as numerically higher rates of deep vein thrombosis (IRR = 1.23) and ischemic stroke (IRR = 1.82)—although, the latter two events were not considered significant.

On the contrary, sphingosine 1-phopshate receptor modulators were linked to decreased rates of all thromboembolic events, with ischemic stroke being the most statistically significant decrease (IRR = 0.33; P<.05).

“Although additional studies are warranted to validate these findings, the elevated risks of thromboembolic events and the associated risk factors among patients with IMDs should be carefully considered when optimizing treatment to appropriately balance risks and benefits of the chosen therapy in this patient population,” Setyawan and colleagues concluded.

The study, "Risk of thromboembolic events and associated risk factors, including treatments, in patients with immune-mediated diseases," was published online in Clinical Therapeutics.

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