TOPLINE:

Among 12,245 patients with Crohn’s disease treated with advanced therapies, no significant differences were found in the risks for serious infections, venous thromboembolism, or major adverse cardiovascular events across treatments. These findings suggested that safety concerns should not be the primary driver when selecting advanced therapies for these patients.

METHODOLOGY:

• Since the late 1990s, treatment for Crohn’s disease has expanded from TNF-alpha antagonists to risankizumab, ustekinumab, vedolizumab, and small molecules such as upadacitinib, yet data on comparative safety remain limited.
• Researchers conducted a retrospective comparative effectiveness study between January 2016 and December 2022, with a mean follow-up duration of 26.9 months, analyzing data of 12,245 commercially insured patients with Crohn’s disease (mean age, 46.5 years; 54.2% women).
• The patients had initiated treatment with TNF-alpha antagonists (n = 5274), risankizumab (n = 559), upadacitinib (n = 152), ustekinumab (n = 3544), or vedolizumab (n = 2716).
• The risks for serious infections, venous thromboembolism, and major adverse cardiovascular events were compared across therapy classes.

TAKEAWAY:

• The incidence rates of serious infection ranged from 5.46 to 9.02 per 100 person-years across therapies, with no statistically significant differences across agents.
• The incidence rates of venous thromboembolism ranged from 0.90 to 2.33 per 100 person-years, and those of major adverse cardiovascular events ranged from 0.68 to 1.49 per 100 person-years, with no significant differences in the risks across agents.
• Ustekinumab was associated with a lower risk for gastrointestinal serious infection than vedolizumab (hazard ratio, 0.72; 95% CI, 0.56-0.93).

IN PRACTICE:

“The study’s findings of a broadly comparable safety profile among current treatment options support individualized therapy selection based on clinical and patient-centered factors, with a greater emphasis on effectiveness,” the authors wrote.

SOURCE:

The study was led by Soo-Kyung Park, MD; Dhruv Ahuja, MBBS; and Kuan-Hung Yeh, BS, of the Department of Medicine, University of California San Diego. It was published online in JAMA Network Open.

LIMITATIONS:

The study did not have access to individual patient medical records, endoscopy reports, or biochemical parameters. The number of patients treated with JAK inhibitors was relatively small. Additionally, risankizumab received FDA approval in 2022, resulting in a smaller sample size and shorter follow-up duration for this treatment group.

DISCLOSURES:

The study was supported by the Crohn’s & Colitis Foundation and the National Institute of Diabetes and Digestive and Kidney Diseases, which is a part of the National Institutes of Health. Some authors reported receiving consulting or advisory fees, speaking fees, royalties, and/or research support from various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.