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On April 25, 2025, we reported on a study published in Clinical Gastroenterology and Hepatology that was designed to describe the real-world effectiveness and safety of upadacitinib in people with Crohn disease (CD).
The study
Researchers conducted the retrospective analysis in 334 adults aged 18 years and older across 9 US tertiary IBD centers who received upadacitinib 45 mg daily for active luminal CD. The primary goals were to evaluate clinical remission at 12 weeks and endoscopic remission at 6 months. Secondary outcomes included longer-term clinical response, steroid cessation, and radiographic improvement.
The findings
At 12 weeks, 52.1% of patients achieved clinical remission, with 90.4% of those corticosteroid-free. At 6 months, clinical remission was maintained in 55.9%, and 94% remained off steroids. Endoscopic remission at 6 months was observed in 42.7% of patients.
In multivariable analysis, longer disease duration and higher body mass index were independently associated with lower odds of achieving 12-week clinical remission. Adverse events (AEs) were reported in 13.5% of patients, most commonly acne (3.3%), herpes zoster (2.4%), and venous thromboembolism (0.6%). No malignancies or major cardiovascular events were reported.
Authors' comments
"These findings highlight [upadacitinib's] potential as an effective therapy positioned as a second-line and beyond but also highlights the need for further studies to reevaluate its position to where it may serve as the most effective therapy while balancing the risk of AEs."
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