Crohn Disease, Upadacitinib
Conditions
Brief summary
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.
Interventions
DRUGUpadacitinib
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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* confirmed diagnosis of Crohn's disease (CD) based on the 2023 Chinese clinical practice guidelines (Guangzhou); * initiated upadacitinib treatment (45 mg once daily) and completed at least 12 weeks of follow-up; * underwent intestinal ultrasound examinations both before treatment initiation and at week 12
Exclusion criteria
* age \<18 years; * concomitant use of other CD medications during upadacitinib treatment, including glucocorticoids, mesalazine, immunosuppressants, or biologics; * undergoing surgical intervention during the upadacitinib treatment period * history of other gastrointestinal diseases (e.g., ulcerative colitis, intestinal tuberculosis); * incomplete clinical data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS) | from baseline to week 12 | The maximum value of IBUS-SAS (International Bowel Ultrasound Segment Activity Score) is 100. The theoretical minimum is 4, but the clinically effective minimum is 0. In general, the lower the score, the milder the intestinal inflammation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radiographic response | at week 12 | 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 to week 12 | The Crohn's Disease Activity Index (CDAI) has a theoretical maximum of 1100 and a theoretical minimum of 0. Consistent with the definition of disease activity in this scoring system, the lower the score, the lower the disease activity and the better the clinical status. |
| changes in laboratory parameters (C-reactive protein） | from baseline to week 12 | — |
| changes in laboratory parameters (Erythrocyte sedimentation rate) | from baseline to week 12 | — |
Countries
China
Outcome results
None listed