Clinical Research Directory

Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease

Background \& Aims: Isolated small bowel Crohn's disease (CD) is defined by involvement of the ileum, jejunum, or extensive small intestinal segments in the absence of colonic disease. This phenotype presents a therapeutic challenge, as biologic agents demonstrate reduced efficacy in this subgroup. Data on the use of upadacitinib specifically for isolated small bowel CD remain limited. This study aimed to evaluate the efficacy of upadacitinib in patients with this phenotype using the International Bowel Ultrasound Segment Activity Score (IBUS-SAS). Methods: A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted. Based on whether the disease involved the small bowel, individuals were categorized into an isolated small bowel CD group and a non-small bowel CD group. The primary endpoint was the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS) from baseline to week 12. Secondary endpoints at week 12 included radiographic response (defined as a\>25% or\>2.0 mm reduction in bowel wall thickness \[BWT\] from baseline, or a\>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade), change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI) from baseline, and changes in laboratory parameters (C-reactive protein, erythrocyte sedimentation rate). Statistical analyses included between-group comparisons, within-group comparison and logistic regression to identify predictors of radiographic response.

Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

Anal fistula is the most common perianal lesion of Crohn's disease (CD), and the incidence of anal fistula in eastern CD population is significantly higher than that in Western population. The treatment of CD active anal fistula is difficult, which seriously affects the quality of life of patients and consumes a lot of medical resources. Injection of biological agents is the most commonly used method for the treatment of CD anal fistula, small molecule drugs can be taken orally, and the curative effect is more lasting. Upadacitinib was the first small molecule drug approved for CD treatment in China on June 30, 2023. At present, there is only one post-subgroup analysis of a global Phase 3 clinical study on Upatinib in the treatment of CD anal fistula, and the number of active anal fistula cases included is small, and the study objects are mostly western populations. This study intends to include CD patients with active anal fistula, and adopts the method of single-center single-arm study to explore the efficacy of Upatinib in the treatment of CD anal fistula, so as to provide more evidence-based medical evidence for the drug selection of CD anal fistula in China.