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.
Study Type
OBSERVATIONAL
Enrollment
21
A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Clinical Remission Rate at Week 12
he proportion of patients achieving clinical remission at 12 weeks, as defined by \[Specify the definition of clinical remission, e.g., "a Mayo score ≤ 2 with no individual subscore \> 1" for UC or "a PCDAI score \< 10" for CD\].
Time frame: Week 12
Endoscopic Response Rate at Week 12
The proportion of patients achieving endoscopic response at 12 weeks, as defined by \[Specify the definition of endoscopic response, e.g., "a decrease of ≥50% from baseline in the SES-CD score" for CD or "a decrease of ≥ 1 point from baseline in the UCEIS" for UC\].
Time frame: Week 12
Clinical Response Rate at Week 12
The proportion of patients achieving clinical response at 12 weeks, as defined by \[Specify the definition of clinical response, e.g., "a decrease of ≥ 3 points from baseline in the Mayo score" for UC or "a decrease of ≥ 20 points from baseline in the PCDAI score" for CD\].
Time frame: Week 12
Change in CRP from Baseline to Week 12
The change in C-reactive protein (CRP) levels from baseline to 12 weeks after treatment initiation.
Time frame: Baseline to Week 12
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