Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis (UPA-AGE)

Sun Yat-sen University

Status

Completed

Conditions

Refractory Crohn's Disease

Geriatric Ulcerative Colitis

Inflammatory Bowel Disease (IBD)

Refractory Ulcerative Colitis

Ulcerative Colitis (UC)

Pediatric Crohn's Disease

Crohn's Disease (CD)

Treatments

Drug: Upadacitinib

Study type

Observational

Funder types

Other

Identifiers

NCT06922331

2025ZSLYEC-149

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

9 to 99 years old

Volunteers

No Healthy Volunteers

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)