Advanced Crohn's Treatments Show Similar Safety Profiles

No significant differences found in risks for serious infections, blood clots, or heart issues across therapy classes.

Published on Feb. 13, 2026

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A retrospective study of over 12,000 Crohn's disease patients found no meaningful differences in the safety profiles of advanced treatments like TNF-alpha antagonists, risankizumab, upadacitinib, ustekinumab, and vedolizumab. The incidence rates of serious infections, blood clots, and major cardiovascular events were comparable across therapy classes, suggesting safety should not be the primary driver when selecting treatments for these patients.

Why it matters

As treatment options for Crohn's disease have expanded in recent years, understanding the comparative safety of these advanced therapies is crucial to help clinicians and patients make informed decisions. This study provides reassurance that safety concerns should not overly influence treatment selection, allowing a greater focus on the effectiveness of these medications.

The details

Researchers analyzed data on 12,245 commercially insured Crohn's disease patients who initiated treatment with TNF-alpha antagonists, risankizumab, upadacitinib, ustekinumab, or vedolizumab between 2016-2022. They found no statistically significant differences in the incidence rates of serious infections, venous thromboembolism, or major adverse cardiovascular events across the therapy classes. The only exception was that ustekinumab was associated with a lower risk of gastrointestinal serious infections compared to vedolizumab.

  • The study analyzed data from January 2016 to December 2022, with a mean follow-up duration of 26.9 months.
  • Risankizumab received FDA approval in 2022, resulting in a smaller sample size and shorter follow-up duration for this treatment group.

The players

Soo-Kyung Park, MD

Lead author of the study, from the Department of Medicine at the University of California San Diego.

Dhruv Ahuja, MBBS

Co-author of the study, from the Department of Medicine at the University of California San Diego.

Kuan-Hung Yeh, BS

Co-author of the study, from the Department of Medicine at the University of California San Diego.

Crohn's & Colitis Foundation

Provided funding support for the study.

National Institute of Diabetes and Digestive and Kidney Diseases

Part of the National Institutes of Health, which provided funding support for the study.

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What they’re saying

“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.”

— Study authors (JAMA Network Open)

The takeaway

This study provides important reassurance that the safety profiles of advanced Crohn's disease treatments are generally comparable, allowing clinicians and patients to focus more on the relative effectiveness of these medications when making treatment decisions.