BMC gastroenterology · 2026
Effectiveness and safety of vedolizumab in real-world studies in Asian patients with inflammatory bowel disease: a systematic review and meta-analysis.
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Gu Yubei, Zhang Xiaoyan, Gu Lifei, Zou Duowu
Аннотация
BACKGROUND: To evaluate the real-world effectiveness and safety of vedolizumab (VDZ) in Asian patients with IBD, including Crohn's disease (CD) and Ulcerative colitis (UC).
METHODS: We systematically searched PubMed, EMBASE, the Cochrane Library, Web of Science, CBM, CNKI, Wanfang, and VIP for real-world studies assessing intravenous VDZ in Asian IBD patients. Primary outcomes were clinical remission, response and endoscopic remission. Secondary outcomes encompassed corticosteroid-free clinical remission, endoscopic response, complete endoscopic remission, C-reactive protein remission, faecal calprotectin normalization, treatment persistence rate and safety variables. Meta-analysis was performed for CD and UC across induction (6-14 weeks), medium term (22-30 weeks), and long term (over 48 weeks) using a random-effects model.
RESULTS: Twenty-nine studies with 2395 patients were included. Induction clinical remission and response was 61.15% and 57.48% for CD, and 40.07% and 64.72% for UC. Medium-term clinical remission and response was 60.72% and 64.32% for CD, and 43.51% and 64.87% for UC. Long-term clinical remission and response for CD was 45.83% and 44.55%, for UC was 56.14% and 61.35%. Endoscopic remission improved across induction, medium term, and long-term for CD (11.11%, 18.41% and 36.42%) and UC (43.19%, 54.27% and 66.72%). Within the longest follow up of 52 weeks, adverse event rate ranged widely from 6.67% to 61.54% for CD and 29.69% to 75.38% for UC. Chinese patients and both biologic-naïve and biologic-experienced patients showed similar favorable outcomes.
CONCLUSION: VDZ demonstrated overall favourable effectiveness in Asian IBD patients, with a safety profile aligned with global data.
TRIAL REGISTRATION: The protocol was registered on National Institution for Health and Care Research (registration number CRD420251000408).
METHODS: We systematically searched PubMed, EMBASE, the Cochrane Library, Web of Science, CBM, CNKI, Wanfang, and VIP for real-world studies assessing intravenous VDZ in Asian IBD patients. Primary outcomes were clinical remission, response and endoscopic remission. Secondary outcomes encompassed corticosteroid-free clinical remission, endoscopic response, complete endoscopic remission, C-reactive protein remission, faecal calprotectin normalization, treatment persistence rate and safety variables. Meta-analysis was performed for CD and UC across induction (6-14 weeks), medium term (22-30 weeks), and long term (over 48 weeks) using a random-effects model.
RESULTS: Twenty-nine studies with 2395 patients were included. Induction clinical remission and response was 61.15% and 57.48% for CD, and 40.07% and 64.72% for UC. Medium-term clinical remission and response was 60.72% and 64.32% for CD, and 43.51% and 64.87% for UC. Long-term clinical remission and response for CD was 45.83% and 44.55%, for UC was 56.14% and 61.35%. Endoscopic remission improved across induction, medium term, and long-term for CD (11.11%, 18.41% and 36.42%) and UC (43.19%, 54.27% and 66.72%). Within the longest follow up of 52 weeks, adverse event rate ranged widely from 6.67% to 61.54% for CD and 29.69% to 75.38% for UC. Chinese patients and both biologic-naïve and biologic-experienced patients showed similar favorable outcomes.
CONCLUSION: VDZ demonstrated overall favourable effectiveness in Asian IBD patients, with a safety profile aligned with global data.
TRIAL REGISTRATION: The protocol was registered on National Institution for Health and Care Research (registration number CRD420251000408).