Effectiveness and safety of vedolizumab in real-world studies in Asian patients with inflammatory bowel disease: a systematic review and meta-analysis

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).

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.

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.

VDZ demonstrated overall favourable effectiveness in Asian IBD patients, with a safety profile aligned with global data.

The protocol was registered on National Institution for Health and Care Research (registration number CRD420251000408).