Upadacitinib with or without vedolizumab for 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

This study tests whether adding vedolizumab to upadacitinib helps adults with moderate-to-severe ulcerative colitis achieve better short-term (8-week) control than upadacitinib alone.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Drugs / interventions: vedolizumab, upadacitinib, infliximab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07442045 on ClinicalTrials.gov

What this trial studies

This is a multicenter retrospective cohort using electronic medical records and pharmacy data from six tertiary IBD centers in China to compare upadacitinib monotherapy versus upadacitinib combined with vedolizumab. Adult patients with moderately to severely active ulcerative colitis who started upadacitinib between January 2023 and December 2025 and had baseline and 8-week follow-up data are included. Short-term outcomes include clinical remission and response, endoscopic remission, CRP normalization, and adverse events during the 8-week induction period. The analysis reflects routine clinical practice and aims to provide real-world comparative safety and effectiveness information.

Who should consider this trial

Good fit: Adults (≥18) with established moderate-to-severe ulcerative colitis (modified Mayo score ≥4 and endoscopic subscore ≥2) who are starting upadacitinib, with or without vedolizumab, and have baseline plus 8-week follow-up data.

Not a fit: Patients with Crohn's disease or indeterminate colitis, those with prior or planned colectomy, patients with only mild UC, or those lacking sufficient baseline or 8-week data are not appropriate for this comparison and unlikely to benefit from its conclusions.

Why it matters

Potential benefit: If successful, combining vedolizumab with upadacitinib could help more patients achieve faster and more complete induction of remission without major unexpected safety issues.

How similar studies have performed: Small case series and some real-world reports have suggested benefit from dual-targeted approaches in refractory IBD, but high-quality comparative data specifically on upadacitinib plus vedolizumab versus upadacitinib alone remain limited.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• the Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jiayin Yao

Conditions Ulcerative Colitis; Upadacitinib; Vedolizumab; Combination Therapy; Real-World Study