RecruitingNCT07442045

Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis

Real-World Comparative Effectiveness and Safety of Upadacitinib Plus Vedolizumab Versus Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis: A Multicenter Retrospective Cohort Study

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

150 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis (UC)

Summary

This multicenter retrospective cohort study evaluates the real-world effectiveness and safety of upadacitinib used alone or in combination with vedolizumab in adult patients with moderate-to-severe ulcerative colitis (UC). UC is a chronic inflammatory bowel disease that often requires long-term management, and monotherapy may reach a therapeutic ceiling in clinical practice. Combination therapy with upadacitinib, a rapid-acting oral JAK inhibitor, and vedolizumab, a gut-selective biologic, may provide complementary benefits. The study uses existing clinical and laboratory data from six Chinese IBD centers to compare short-term outcomes, including clinical remission, clinical response, endoscopic remission, normalization of C-reactive protein, and occurrence of adverse events during the 8-week induction period. This study reflects routine clinical practice and aims to provide real-world evidence to support treatment decisions in patients with moderate-to-severe UC.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Age ≥18 years at the time of treatment initiation.
Established diagnosis of ulcerative colitis (UC) for at least 3 months prior to index date, confirmed by compatible clinical presentation, endoscopic findings, and histopathological evidence.
Moderately to severely active disease at baseline, defined as a modified Mayo score ≥4 with an endoscopic subscore (ESS) ≥2.
Initiation of treatment with upadacitinib, either as monotherapy or in combination with vedolizumab, in routine clinical practice at participating centers.
Availability of baseline clinical assessment and follow-up data at 8 weeks after initiation of upadacitinib.

Exclusion Criteria5

Diagnosis of Crohn's disease, indeterminate colitis, or other non-UC colitis.
Prior colectomy or planned colectomy at the time of treatment initiation.
Participation in an interventional clinical trial involving upadacitinib during the study period.
Insufficient clinical data to assess baseline disease activity or week 8 outcomes.
Concomitant use of other advanced therapies (biologics or small molecules) initiated after the index date, except for vedolizumab in the combination group.