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

NCT07442045 | Recruiting DMC

• 1 other identifier: 2026ZSLYEC-079
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 6

Brief Summary

This multicenter retrospective comparative cohort study evaluated the real-world effectiveness and safety of upadacitinib plus vedolizumab compared with upadacitinib monotherapy during 8-week induction in adults with moderate-to-severe ulcerative colitis. Consecutive eligible patients who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, between January 2023 and September 2025 at six tertiary inflammatory bowel disease referral centers in China were included. The primary outcome was modified Mayo clinical remission at week 8. Secondary outcomes were modified Mayo clinical response, C-reactive protein normalization among patients with an elevated baseline C-reactive protein concentration, and endoscopic remission. Safety outcomes were assessed from the index date through the week-8 assessment.

Conditions

Ulcerative Colitis (UC)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate at the 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 Outcomes (3)

• Clincial response rate at the 8th week

  8th-week

• C-Reactive Protein normalization rate at the 8th week

  8th-week

• Endoscopic remission rate at the 8th week

  8th-week

Other Outcomes (1)

• Adverse Events During the 8-Week Induction Period

  Week 0 to Week 8

Study Arms (2)

Upadacitinib Plus Vedolizumab

Patients received oral upadacitinib 45 mg once daily for 8 weeks and intravenous vedolizumab 300 mg at weeks 0, 2, and 6 during induction.

Drug: Upadacitinib; Drug: Vedolizumab

Upadacitinib Monotherapy

Patients received oral upadacitinib 45 mg once daily for 8 weeks without concomitant vedolizumab or another advanced therapy.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

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

Upadacitinib Monotherapy; Upadacitinib Plus Vedolizumab

Vedolizumab DRUG

Vedolizumab 300mg intravenously on weeks 0, 2, 6.

Upadacitinib Plus Vedolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of consecutive adults aged 18 years or older with an established diagnosis of moderate-to-severe ulcerative colitis who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, at six tertiary inflammatory bowel disease referral centers in China between January 2023 and September 2025. The index date was defined as the date of upadacitinib initiation. Treatment was selected by the treating physician as part of routine clinical care.

You may qualify if:

• Age 18 years or older at the index date.
• Established diagnosis of ulcerative colitis for at least 3 months, supported by compatible clinical, endoscopic, and histologic findings.
• Moderately to severely active ulcerative colitis at baseline, defined as a modified Mayo score of 4 to 9 and a Mayo endoscopic subscore of at least 2.
• Initiation of upadacitinib induction therapy during the predefined study period.
• For the combination-therapy group, initiation of vedolizumab concomitantly with upadacitinib at the index date.

You may not qualify if:

• Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis.
• Previous colectomy or colectomy planned at the index date.
• Previous exposure to upadacitinib or vedolizumab.
• Initiation of another biologic or small-molecule advanced therapy during the 8-week induction period, except for vedolizumab in the combination-therapy group.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (6)

The First People's Hospital of Foshan

Foshan, Guangdong, 510260, China

RECRUITING

Foshan Fosun Chancheng Hospital, Foshan

Foshan, Guangdong, 528000, China

RECRUITING

The Sixth Affiliated Hospital, South China University of Technology City: Foshan

Foshan, Guangdong, 528200, China

RECRUITING

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 501655, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

the Second Affiliated Hospital of Shenzhen University (People's Hospital of Shenzhen Bao'an District)

Shenzhen, Guangdong, 518000, China

RECRUITING

Related Publications (3)

• Yao J, Wu H, Wu L, Yu Q, Cao X, Xie T, Zhong X, Chen H, Wu J, Liu X, Shi L, Zhang M, Peng X, Deng J, Wang W, Liu T, Su T, Yang H, Xia D, Zhi M. Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 May 22:S1542-3565(26)00388-5. doi: 10.1016/j.cgh.2026.05.010. Online ahead of print.

  PMID: 42173298 BACKGROUND

• Gilmore R, Murali A, Etchegaray A, Swe E, An YK, Begun J. Upadacitinib and vedolizumab combination therapy for the management of refractory ulcerative colitis and Crohn's disease. Intest Res. 2025 Oct;23(4):475-482. doi: 10.5217/ir.2024.00174. Epub 2025 Jun 9.

  PMID: 40490017 BACKGROUND

• Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.

  PMID: 35644166 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

upadacitinib; vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Jiayin Yao

CONTACT

13826462890; yjyin@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 2, 2026
• Study Start: January 1, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)