P1066 Effectiveness and safety of vedolizumab in real-world studies in Asian patients with inflammatory bowel disease: a systematic review and meta-analysis

Abstract Background Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic gastrointestinal disorders with rising prevalence in Asia. Vedolizumab (VDZ) is a humanized monoclonal antibody targeting α4β7 integrin, selectively blocking gut lymphocyte trafficking. Despite numerous real-world studies on VDZ use in Asian patients with IBD over recent years, a comprehensive analysis summarizing its effectiveness and safety is still lacking. This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of VDZ in Asian patients with IBD. Methods A literature search was conducted to identify real-world studies evaluating intravenous VDZ in Asian patients with IBD from inception to 20th December 2023. Meta-analyses were performed separately for CD and UC patients to pool clinical and endoscopic remission and response rates across induction (6-14 weeks), medium term (22-30 weeks), and long term (over 48 or 52 weeks) using a random-effects model in R software. The incidence of adverse events (AE), serious AE (SAE), and serious infection were assessed for safety. Results Twenty-nine studies (15 CD and 25 UC) with 2,395 patients (827 CD, 1,568 UC) were analysed (Figure 1). In the induction phase, clinical response and remission were achieved in 57.48% and 61.15% of CD patients, and 64.72% and 40.07% of UC patients. In the medium term, clinical response and remission were 64.32% and 60.72% for CD, and 64.87% and 43.51% for UC. In the long term, the clinical response and clinical remission rate were 44.55% and 45.83% in CD patients, 61.35% and 56.14% in UC patients. Moreover, corticosteroid-free clinical remission was achieved by 36.58% of that in CD and 49.03% of that in UC for the long-term observation. Endoscopic response was achieved by 41.37% of CD patients and 48.57% of UC patients during induction phase. Endoscopic remission rates for CD were 11.11%, 18.41%, and 36.42%, and for UC 43.19%, 54.27%, and 66.72% in induction, medium, and long term, respectively. The pooled complete endoscopic remission rates for UC were 27.98% (induction), 47.87% (medium term), and 50.61% (long term) (Table 1). AEs occurred in 6.67% to 61.54% of CD patients and 29.69% to 75.38% of UC patients. SAEs and serious infection rates were 0.00% to 1.56% and 0.00% to 2.70% in UC patients, and 0.00% to 0.75% for serious infections in CD, with no SAEs reported in CD studies. Conclusion VDZ demonstrated effective clinical outcomes with a favourable safety profile in Asian patients with IBD.