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Efficacy and safety of vedolizumab combined with upadacitinib as an 8-week induction strategy in moderate-to-severe ulcerative colitis: a multicenter, randomized controlled trial

H. Wu, L. Wu, T. Xie, J. Wu, H. Chen, Q. Yu, X. Cao, M. Zhi, J. Yao

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Slides compiled by Dr. Reena Khanna

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Introduction

Background and objectives

    • Advanced monotherapies in UC may face an “efficacy ceiling” (~30% induction remission).
    • One potential strategy to address this is a ‘hit-hard-and-early’ strategy combining potent, rapid upadacitinib (UPA) for induction with gut-selective, safe vedolizumab (VDZ).
    • Objective: Test whether 8-week UPA+VDZ induction is superior to VDZ monotherapy.

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UC, ulcerative colitis; UPA, upadacitinib; VDZ, vedolizumab; MES, Mayo endoscopic score; HEMI, histologic-endoscopic mucosal improvement

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

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Methods

    • Design: Prospective, multicenter, randomized, open-label trial
    • Population: Adults with moderate-to-severe UC (modified Mayo 4-9, MES≥2).
    • Arms (Randomized 1:2): Combination (VDZ 300mg IV wks 0,2,6 + UPA 45mg PO daily for 8 wks) or VDZ monotherapy (VDZ 300mg IV wks 0,2,6).
    • Primary endpoint (week 8): endoscopic remission (MES=0)
    • Secondary endpoint (week 8): clinical remission; histologic-endoscopic mucosal improvement (HEMI)

Assessments:

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Results

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MES, Mayo endoscopic score; OR, odds ratio; CI, confidence interval

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

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Endoscopic Remission

    • The primary endpoint of endoscopic remission (MES=0) was met:
      • Combo: 37.5% (15/40)
      • Mono: 15.1% (11/73)
    • Absolute risk difference = 22.4%; 95% CI 5.3-39.5; P=0.007
    • Adjusted OR = 3.34; 95% CI 1.34-8.58

Combo

Combo

Mono

Mono

Clinical Remission

    • Combination therapy also improved clinical remission (P=0.013):
      • Combo: 66.7%
      • Mono: 40.0%

Endoscopic Remission

Clinical Remission

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Results

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HEMI, histologic-endoscopic mucosal improvement; OR, odds ratio; CI, confidence interval; SAE, serious adverse events

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

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HEMI

    • Histologic-endoscopic mucosal improvement was increased with combination therapy:
      • Combo: 45.7%
      • Mono: 17.7%
    • Adjusted OR = 3.58; 95% CI 1.41-9.41; P=0.008

Combo

Combo

Mono

Mono

Adverse Events

    • Adverse events during the 8-week induction were comparable (P=0.9):
      • Combo: 7.5%
      • Mono: 7.0%
    • No SAEs were reported

HEMI

Adverse Event

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Conclusions

    • In this two-arm study, combination vedolizumab and upadicitinib was superior to vedolizumab monotherapy to attain clinical remission, endoscopic remission, and HEMI at week 8.
    • No increase in adverse events was observed.

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Significance to clinical practice

    • Although data for dual advanced therapy is important for clinical practice, the lack of a UPA monotherapy arm limits conclusions about the incremental benefit of vedolizumab.
    • Longer term data to establish durability of this early response is required.
    • The safety profile is promising.

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

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