P1042 Effectiveness and safety of vedolizumab in real-world studies in Chinese patients with inflammatory bowel disease: a systematic review and meta-analysis

Abstract Background Inflammatory bowel diseases (IBD), consisting of Crohn’s disease (CD) and ulcerative colitis (UC), are chronic gastrointestinal conditions with increasing prevalence in China. Vedolizumab (VDZ), a humanized monoclonal antibody that targets α4β7 integrin, has been approved for use in China since 2020. This systematic review and meta-analysis aimed to evaluate the real-world effectiveness and safety of VDZ in Chinese patients with IBD. Methods A systematic literature search was conducted on 20th Dec 2023 to identify real-world studies evaluating intravenous VDZ in Chinese patients with IBD. Meta-analyses were performed separately for CD and UC patients using a random-effects model in R software to pool clinical remission and response rates, and endoscopic remission rates across induction (6-14 weeks), medium term (22-30 weeks), and long term (over 48 or 52 weeks). Subgroup analysis was conducted based on the history of biologics. Incidence of adverse events (AE), serious AE (SAE), and serious infection was assessed for safety. Results A total of 20 studies (12 CD, and 15 UC), involving 1472 patients (610 CD, and 862 UC), were included in the analysis (Figure 1). During the induction phase, a clinical response and clinical remission were achieved by 71.31% and 75.58% of CD patients, and 67.89% and 46.46% of UC patients, respectively. In the medium term, 64.32% of CD patients and 65.72% of UC patients achieved a clinical response, while 60.72% of CD patients and 60.95% of UC patients achieved clinical remission. In the long term, clinical response rates were 57.14% in CD patients and 73.50% in UC patients, while clinical remission rates were 51.28% and 60.84% for CD and UC patients, respectively. For the endoscopic remission, there were 11.11%, 18.41%, and 36.42% of that in CD patients, and 44.58%, 53.32%, and 62.40% of that in UC patients were achieved in the induction, medium term, and long term. Subgroup analyses indicated that both bio-naïve and bio-exposed patients, in both UC and CD groups, showed relatively favourable outcomes across the available time points (Table 1). Adverse events (AEs) were reported in 6.67% to 61.54% of CD patients, and 29.69% to 75.38% of UC patients. Serious adverse events (SAEs) and serious infection rates ranged from 0.00% to 1.56%, and 0.00% to 2.70%, respectively, in UC patients, while neither SAE nor serious infections were reported in the CD studies. Conclusion VDZ demonstrated favourable effectiveness in Chinese patients with IBD across induction, medium- and long-term treatment periods, with a good safety profile.