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

February 24, 2026 updated by: Jiayin Yao, Sixth Affiliated Hospital, Sun Yat-sen University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This multicenter retrospective cohort study aims to compare the real-world effectiveness and safety of upadacitinib in combination with vedolizumab versus upadacitinib monotherapy in adult patients with moderate-to-severe ulcerative colitis (UC).

Ulcerative colitis is a chronic relapsing inflammatory bowel disease requiring long-term management. Although multiple biologic agents and small-molecule therapies have been approved, the efficacy of monotherapy in moderate-to-severe disease remain limited. Increasing evidence suggests that combination strategies using two targeted therapies may overcome the therapeutic ceiling observed with single-agent treatment. Upadacitinib, an oral selective Janus kinase (JAK) inhibitor, is characterized by rapid onset of action, while vedolizumab, a gut-selective anti-integrin biologic, has a favorable safety profile but relatively slower onset. The combination of these agents may theoretically provide complementary mechanisms, enabling rapid induction of remission together with sustained disease control. However, direct comparative real-world evidence evaluating these two treatment strategies remains limited.

This study is conducted in routine clinical practice settings across six tertiary inflammatory bowel disease centers in China. Patients were identified through institutional pharmacy databases and electronic medical records. The study period includes patients treated between January 2023 and December 2025. The index date was defined as the initiation of upadacitinib therapy. Patients were categorized according to baseline treatment strategy into two groups: upadacitinib monotherapy or upadacitinib in combination with vedolizumab .Eligible patients were adults (≥18 years) with moderate-to-severe UC, defined as a baseline modified Mayo score ≥4 and an endoscopic subscore ≥2.

Baseline demographic and clinical variables included age, sex, smoking history, disease extent, disease duration, prior exposure to corticosteroids, exclusive enteral nutrition, immunosuppressants, and infliximab. Laboratory parameters collected at baseline and at week 8 included C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), albumin, hemoglobin, and platelet count. Endoscopic Mayo score and modified Mayo score were also assessed at baseline and week 8.

The primary outcome was clinical remission at week 8. Secondary outcomes included clinical response at week 8, endoscopic remission at week 8, CRP normalization at week 8, and occurrence of adverse events during the 8-week induction period. Baseline characteristics were summarized descriptively. Multivariable regression models and propensity score matching methods were applied to adjust for potential confounding factors and baseline imbalances between treatment groups. Sensitivity analyses were conducted to assess the robustness of findings.

This study was conducted in routine clinical practice settings and was approved by the institutional review boards of all participating centers.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 501655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) with a confirmed diagnosis of ulcerative colitis (UC) who received upadacitinib either as monotherapy or in combination with vedolizumab in routine clinical practice at participating six tertiary inflammatory bowel disease centers in China.

Eligible patients were identified through institutional pharmacy databases and electronic medical records. All included patients had active moderate-to-severe UC at baseline, defined by a modified Mayo score ≥4 and an endoscopic subscore ≥2.

Patients were treated according to physician discretion in real-world settings.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Combination treatment group
A combination treatment of Upadacitinib and Vedolizumab for 8 weeks in the induction therapy.
Drug: Upadacitinib
Oral Upadacitinib 45mg/d for 8 weeks in the induction therapy.
Drug: Vedolizumab
Vedolizumab 300mg intravenously on weeks 1, 2, 6.
Single treatment group
Single treatment of Upadacitinib in the induction therapy
Drug: Upadacitinib
Oral Upadacitinib 45mg/d for 8 weeks in the induction therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission rate at the 8th-week
Time Frame: 8th-week
Clinical remission is defined as a total Mayo score ≤2, with no individual subscore >1 and a rectal bleeding subscore of 0.
8th-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clincial response rate at the 8th week
Time Frame: 8th-week
Clinical response is defined as a decrease in total Mayo score by ≥3 points and ≥30% from baseline, with a decrease in rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1.
8th-week
CRP normalization rate at the 8th week
Time Frame: 8th-week
CRP normalization is defined as a C-reactive protein(CRP) level ≤5 mg/L, corresponding to the upper limit of normal in our laboratory.
8th-week
Endoscopic remission rate at the 8th week
Time Frame: 8th-week
Endoscopic remission is defined as Mayo endoscopic score(MES) =0
8th-week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Week 0 to Week 8
The number and type of adverse events occurring during the 8-week treatment period.
Week 0 to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026ZSLYEC-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional policies and patient privacy considerations. The dataset contains identifiable clinical information from multiple centers, and data sharing is restricted by local ethics committee regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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