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.
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.
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.
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.
Cohort
Retrospective
Upadacitinib
DrugOral Upadacitinib 45mg/d for 8 weeks in the induction therapy.
Vedolizumab
DrugVedolizumab 300mg intravenously on weeks 0, 2, 6.
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.
Clincial response rate at the 8th week
Clinical response was defined as a decrease from baseline in the modified Mayo score of at least 2 points and at least 30%, accompanied by either a decrease in the rectal-bleeding subscore of at least 1 point or an absolute rectal-bleeding subscore of 1 or less.
C-Reactive Protein normalization rate at the 8th week
C-reactive protein normalization was evaluated only among patients with a baseline C-reactive protein concentration greater than 5 mg/L. Normalization was defined as a week-8 serum C-reactive protein concentration of 5 mg/L or less. Patients with a baseline C-reactive protein concentration of 5 mg/L or less were not included in the denominator for this outcome.
Endoscopic remission rate at the 8th week
Endoscopic remission is defined as Mayo endoscopic score(MES) =0
Adverse Events During the 8-Week Induction Period
Safety outcomes included any adverse event, serious adverse events, and permanent treatment discontinuation due to an adverse event. Infections, herpes zoster, thromboembolic events, cardiovascular events, and clinically relevant laboratory abnormalities were recorded when explicitly documented in the electronic medical records, laboratory systems, or medication-administration records.
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