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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease (CD) Ulcerative Colitis (UC) Refractory Crohn's Disease Refractory Ulcerative Colitis Inflammatory Bowel Disease (IBD) Pediatric Crohn's Disease Geriatric Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pediatric Crohn's Disease (CD) Group

Patients aged 9-17 years diagnosed with refractory Crohn's disease who received upadacitinib treatment.

Upadacitinib

Intervention Type DRUG

A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.

Elderly Ulcerative Colitis (UC) Group

Patients aged 60 years or older diagnosed with refractory ulcerative colitis who received upadacitinib treatment.

Upadacitinib

Intervention Type DRUG

A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.

Interventions

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Upadacitinib

A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

9 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No