Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial.
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Yao Jiayin, Wu Hongzhen, Wu Luying, Yu Qiao, Cao Xiaocang, Xie Tingting, Zhong Xuanfang, Chen Huangwei, Wu Ji, Liu Xiaoyu, Shi Lishuo, Zhang Min, Peng Xiang, Deng Jun, Wang Wei, Liu Tao, Su Tao, Yang Hui, Xia Dengning, Zhi Min
Аннотация
BACKGROUND & AIMS: Current advanced therapies for ulcerative colitis face an "efficacy ceiling," with endoscopic remission rates rarely exceeding 30%. We evaluated whether combination therapy-8-week induction with upadacitinib and vedolizumab followed by vedolizumab monotherapy-would be superior to standard vedolizumab monotherapy.
METHODS: In this prospective, multicenter, randomized, open-label, superiority trial at 8 centers in China, adults with moderate-to-severe ulcerative colitis (modified Mayo score 4-9, endoscopic subscore ≥2) were randomized 1:2 to combination therapy (vedolizumab 300 mg intravenously at weeks 0, 2, and 6 plus upadacitinib 45 mg daily for 8 weeks) or vedolizumab monotherapy. The primary endpoint was endoscopic remission (Mayo endoscopic subscore of 0) at week 8, assessed by blinded central readers.
RESULTS: Of 120 randomized patients, 113 comprised the modified intention-to-treat population (40 combination, 73 monotherapy). Endoscopic remission at week 8 was achieved by 37.5% vs 15.1% (absolute risk difference, 22.4 percentage points; 95% confidence interval, 5.3-39.5; adjusted odds ratio, 3.34; 95% confidence interval, 1.34-8.58; P = .010). Clinical remission (65.0% vs 35.6%; P = .002) and histologic-endoscopic mucosal improvement (40.0% vs 13.7%; P = .004) were significantly higher with combination therapy. Adverse event rates were comparable (7.5% vs 6.8%), with no serious adverse events.
CONCLUSIONS: In this open-label trial, combined upadacitinib and vedolizumab induction was superior to vedolizumab monotherapy for achieving endoscopic and clinical remission at week 8 in patients with moderate-to-severe ulcerative colitis. Although these findings should be interpreted with caution, given the early trial termination and open-label design, they provide the first randomized evidence supporting a short-term combination biologic and small-molecule induction strategy.
CLINICALTRIALS: gov, Number: NCT06095596.
METHODS: In this prospective, multicenter, randomized, open-label, superiority trial at 8 centers in China, adults with moderate-to-severe ulcerative colitis (modified Mayo score 4-9, endoscopic subscore ≥2) were randomized 1:2 to combination therapy (vedolizumab 300 mg intravenously at weeks 0, 2, and 6 plus upadacitinib 45 mg daily for 8 weeks) or vedolizumab monotherapy. The primary endpoint was endoscopic remission (Mayo endoscopic subscore of 0) at week 8, assessed by blinded central readers.
RESULTS: Of 120 randomized patients, 113 comprised the modified intention-to-treat population (40 combination, 73 monotherapy). Endoscopic remission at week 8 was achieved by 37.5% vs 15.1% (absolute risk difference, 22.4 percentage points; 95% confidence interval, 5.3-39.5; adjusted odds ratio, 3.34; 95% confidence interval, 1.34-8.58; P = .010). Clinical remission (65.0% vs 35.6%; P = .002) and histologic-endoscopic mucosal improvement (40.0% vs 13.7%; P = .004) were significantly higher with combination therapy. Adverse event rates were comparable (7.5% vs 6.8%), with no serious adverse events.
CONCLUSIONS: In this open-label trial, combined upadacitinib and vedolizumab induction was superior to vedolizumab monotherapy for achieving endoscopic and clinical remission at week 8 in patients with moderate-to-severe ulcerative colitis. Although these findings should be interpreted with caution, given the early trial termination and open-label design, they provide the first randomized evidence supporting a short-term combination biologic and small-molecule induction strategy.
CLINICALTRIALS: gov, Number: NCT06095596.