A large real-world analysis of more than 12,000 patients with Crohn’s disease found broadly similar safety profiles across several biologics and a Janus kinase inhibitor, with no significant differences in rates of serious infections, venous thromboembolism, or major adverse cardiovascular events over about 27 months of follow-up.
Rates of serious infections ranged from roughly 5 to 9 events per 100 person-years across therapies, with no significant differences after adjustment. When examined by type, ustekinumab was associated with a lower risk of gastrointestinal serious infections compared with vedolizumab, while no differences were observed for extraintestinal infections. The most common gastrointestinal infections were perianal abscess and Clostridioides difficile infection; extraintestinal infections included sepsis, pneumonia, and urinary tract infections.
Venous thromboembolism occurred at low rates, generally about 1 event per 100 person-years, with no significant differences between groups. In a sensitivity analysis limited to inpatient or emergency department events, Janus kinase inhibitors were associated with a lower risk, although event counts were small.
Major adverse cardiovascular events were uncommon across all therapies, occurring at rates below 2 events per 100 person-years. No significant differences were observed between groups. No such events occurred among patients treated with upadacitinib during follow-up.
The study, published in JAMA Network Open, included 12,245 commercially insured adults aged 18 to 65 years who initiated advanced Crohn’s disease therapy between 2016 and 2022. The cohort comprised 5,274 patients treated with tumor necrosis factor antagonists, 2,716 treated with vedolizumab, 3,544 treated with ustekinumab, 559 treated with risankizumab, and 152 treated with upadacitinib. Researchers used propensity score–based inverse probability weighting to adjust for demographics, comorbidities, prior medication exposure, health care utilization, and history of serious infection or venous thromboembolism.
The researchers noted several limitations, including reliance on administrative claims data without measures of disease activity, potential residual confounding, low event rates for cardiovascular and thromboembolic outcomes, and shorter follow-up for newer agents, particularly risankizumab.
The study was supported by the Crohn’s and Colitis Foundation and the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Singh reported receiving research grants from Pfizer. Other coauthors reported consulting, speaking, advisory, or research relationships with several pharmaceutical companies.
Source: JAMA Network Open