Abstract Objectives Upadacitinib, a second‐generation Janus kinase (JAK) inhibitor, is approved for moderate to severe Crohn's disease (CD) and ulcerative colitis (UC) in adults. Its efficacy in pediatric patients remains unclear, though early reports suggest benefits in refractory inflammatory bowel disease (IBD). However, data indicate potential relapse after dose reduction. This study evaluates upadacitinib's sustained efficacy in pediatric IBD, particularly when transitioning from induction to maintenance dosing. Methods We conducted a case series of 16 pediatric patients (mean age 16.1 years) treated with upadacitinib for refractory IBD between 2023 and 2024. Treatment responses were analyzed in 8 patients who completed induction (45 mg daily) and transitioned to maintenance dosing (30 or 15 mg daily based on provider preference). Relapse rates and responses to dose adjustments were assessed. Results Among the 16 patients, 8 had UC, 7 had CD, and 1 had IBD‐unclassified. Seven (43.8%; 95% confidence interval CI, 19.4%–68.1%) lost response after transitioning to maintenance, with a median time to relapse of 81.5 days. Of these, 6 (85.7%; 95% CI, 42%–99%) regained response after increasing the dose back to induction dosing. Conclusion Our findings suggest that pediatric patients may require longer induction, higher maintenance doses, or individualized dosing due to pharmacokinetics. Given the high relapse rate in our small cohort, close monitoring and tailored treatment strategies are essential.
Greenhall et al. (Thu,) studied this question.