Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

Completed

• Conditions: Crohn's Disease (CD); Ulcerative Colitis (UC); Pediatric Crohn's Disease; Geriatric Ulcerative Colitis; Refractory Crohn's Disease; Refractory Ulcerative Colitis; Inflammatory Bowel Disease (IBD)
• Interventions: Drug: Upadacitinib

• Registration Number: NCT06922331
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

This single-center, retrospective study aims to evaluate the effectiveness and safety of upadacitinib (UPA) in Asian pediatric patients with refractory Crohn's disease (CD) and elderly patients with refractory ulcerative colitis (UC). The study will analyze data from 21 patients (11 children aged 9-17 with CD and 10 adults aged 60 and older with UC) treated at the Sixth Affiliated Hospital of Sun Yat-sen University between January 2023 and December 2024. The primary objective is to assess the clinical remission rate and endoscopic response rate in both groups. Secondary objectives include comparing treatment outcomes between the two age groups, exploring the impact of immunosenescence on UPA efficacy in elderly UC patients, and analyzing the correlation between laboratory markers (CRP, albumin) and clinical outcomes. This study is the first in Asia to investigate the age-stratified efficacy of upadacitinib in pediatric CD and elderly UC patients. The findings will provide crucial real-world evidence to inform individualized treatment strategies for these specific populations. Patients included in this study will have previously failed at least two biological therapies. Data collected will include demographics, disease characteristics, prior treatment history, UPA dosage and duration, clinical and endoscopic scores (PCDAI/Mayo, SES-CD/UCEIS), imaging results, laboratory values, and adverse events. The study is registered on ClinicalTrials.gov (NCT06274996). Ethical considerations will be addressed through data anonymization and a waiver of informed consent due to the retrospective nature of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Diagnosis of IBD according to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2023)"; Failure of at least two prior biological therapies (anti-TNF/anti-integrin/IL-12/23 inhibitors); Complete baseline and follow-up data (at least 12 weeks))

Exclusion Criteria

• Active infection, malignancy, severe cardiovascular disease, or hepatic/renal insufficiency; Pregnancy or breastfeeding; Use of other JAK inhibitors within 30 days prior to baseline)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Crohn's Disease (CD) Group	Upadacitinib	Patients aged 9-17 years diagnosed with refractory Crohn's disease who received upadacitinib treatment.
Elderly Ulcerative Colitis (UC) Group	Upadacitinib	Patients aged 60 years or older diagnosed with refractory ulcerative colitis who received upadacitinib treatment.

Primary Outcome Measures

Name	Time	Method
Clinical Remission Rate at Week 12	Week 12	he proportion of patients achieving clinical remission at 12 weeks, as defined by \[Specify the definition of clinical remission, e.g., "a Mayo score ≤ 2 with no individual subscore \> 1" for UC or "a PCDAI score \< 10" for CD\].
Endoscopic Response Rate at Week 12	Week 12	The proportion of patients achieving endoscopic response at 12 weeks, as defined by \[Specify the definition of endoscopic response, e.g., "a decrease of ≥50% from baseline in the SES-CD score" for CD or "a decrease of ≥ 1 point from baseline in the UCEIS" for UC\].

Secondary Outcome Measures

Name	Time	Method
Clinical Response Rate at Week 12	Week 12	The proportion of patients achieving clinical response at 12 weeks, as defined by \[Specify the definition of clinical response, e.g., "a decrease of ≥ 3 points from baseline in the Mayo score" for UC or "a decrease of ≥ 20 points from baseline in the PCDAI score" for CD\].
Change in CRP from Baseline to Week 12	Baseline to Week 12	The change in C-reactive protein (CRP) levels from baseline to 12 weeks after treatment initiation.

Trial Locations

Locations (1)

The Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China