RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years at the time of treatment initiation. 2. 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. 3. Moderately to severely active disease at baseline, defined as a modified Mayo score ≥4 with an endoscopic subscore (ESS) ≥2. 4. Initiation of treatment with upadacitinib, either as monotherapy or in combination with vedolizumab, in routine clinical practice at participating centers. 5. Availability of baseline clinical assessment and follow-up data at 8 weeks after initiation of upadacitinib. Who Should NOT Join This Trial: 1. Diagnosis of Crohn's disease, indeterminate colitis, or other non-UC colitis. 2. Prior colectomy or planned colectomy at the time of treatment initiation. 3. Participation in an interventional clinical trial involving upadacitinib during the study period. 4. Insufficient clinical data to assess baseline disease activity or week 8 outcomes. 5. Concomitant use of other advanced therapies (biologics or small molecules) initiated after the index date, except for vedolizumab in the combination group. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age ≥18 years at the time of treatment initiation. 2. 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. 3. Moderately to severely active disease at baseline, defined as a modified Mayo score ≥4 with an endoscopic subscore (ESS) ≥2. 4. Initiation of treatment with upadacitinib, either as monotherapy or in combination with vedolizumab, in routine clinical practice at participating centers. 5. Availability of baseline clinical assessment and follow-up data at 8 weeks after initiation of upadacitinib. Exclusion Criteria: 1. Diagnosis of Crohn's disease, indeterminate colitis, or other non-UC colitis. 2. Prior colectomy or planned colectomy at the time of treatment initiation. 3. Participation in an interventional clinical trial involving upadacitinib during the study period. 4. Insufficient clinical data to assess baseline disease activity or week 8 outcomes. 5. Concomitant use of other advanced therapies (biologics or small molecules) initiated after the index date, except for vedolizumab in the combination group.

Treatments Being Tested

DRUG

Upadacitinib

Oral Upadacitinib 45mg/d for 8 weeks in the induction therapy.

DRUG

Vedolizumab

Vedolizumab 300mg intravenously on weeks 1, 2, 6.

Locations (1)

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China