Upadacitinib in pediatric IBD: 52-week results

Share

Upadacitinib, a selective JAK1 inhibitor approved for adults with inflammatory bowel disease (IBD), may offer durable symptom control for children and adolescents with severe disease, according to a single-center study from Boston Children’s Hospital.

“This study matters because it provides long-term data for upadacitinib, a therapy already commonly used off-label in pediatric IBD but without established evidence for its safety and efficacy in the pediatric population,” lead study author Jennifer Bachand, MD, currently a GI fellow at Stanford University, told GI & Hepatology News.

Reporting at the 2026 Crohn’s & Colitis Congress®, a partnership between the AGA and the Crohn’s & Colitis Foundation, held in Las Vegas, Dr. Bachand, Lauren Collen, MD, and colleagues reviewed outcomes in 48 patients younger than 18 years with Crohn’s disease (CD) or ulcerative colitis (UC) who initiated upadacitinib and were followed for one year. Patients were diagnosed with CD or UC at a mean age of 10.9 years and began upadacitinib at a mean age of 14.1 years. Prior advanced therapy failures included anti–tumor necrosis factor agents (98%), ustekinumab (56%), vedolizumab (46%), tofacitinib (15%), and risankizumab (6%).

At 52 weeks, 81% of patients remained on upadacitinib, suggesting good treatment durability. Among those who continued therapy, 47% of patients with CD and 73% of those with UC achieved corticosteroid-free clinical remission. Inflammatory markers also improved, with 73% of patients demonstrating normalization of C-reactive protein levels. Endoscopic reassessment was available for just over half of the cohort, and 46% of those patients met criteria for endoscopic remission.

“We were surprised by the strong response to upadacitinib in patients who had previously failed tofacitinib, despite both drugs belonging to the same class,” Dr. Bachand said. “Six of the seven patients (86%) who had previously failed tofacitinib therapy remained on upadacitinib at 52 weeks, and four (57%) achieved corticosteroid-free remission. This suggests that failure with one JAK inhibitor does not necessarily preclude a response to upadacitinib, although this finding requires further investigation in larger cohorts.”

She added that the investigators were also surprised by the incidence of abnormal cholesterol levels, observed in 15% of patients. “More guidance is needed on the management of abnormal cholesterol in pediatric patients in remission on upadacitinib,” she said.

Only two patients discontinued treatment because of adverse events, and there were no reports of blood clots, malignancies, or deaths during follow-up. One serious infection was reported.

If larger studies confirm the safety and efficacy of upadacitinib for pediatric IBD, “it could change our treatment algorithm and ultimately lead to FDA approval for pediatric use,” Dr. Bachand concluded. “The particularly strong response in our ulcerative colitis cohort suggests it could become a preferred therapy for pediatric UC patients who have failed other advanced treatments. Larger studies are needed to confirm this difference and guide patient selection.”

The researchers reported no relevant financial disclosures.

Summary content