Abstract Background Vedolizumab (VDZ) is approved for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD) in China.1,2 Real-world data on the application of vedolizumab (VDZ) in Chinese patients (pts) with inflammatory bowel disease (IBD) are scarce. The VALUE (NCT04872491) study evaluated the effectiveness and safety of VDZ in Chinese pts with IBD. Methods In this multicentre, single-arm, prospective, observational study, adult Chinese pts with IBD were enrolled over a 72-week (W) period. Clinical response and remission at W14, W30 and W54, and safety variables were assessed. This abstract focuses on the real-world treatment patterns of VDZ in Chinese IBD pts, since the main results were published previously. Results Of the 500 pts (UC, 409; CD, 91) enrolled; 465 (93.0%) pts were included in the effectiveness analysis set (UC, 376; CD, 89). Table 1 shows baseline pt characteristics. Overall, the mean (standard deviation) duration of VDZ exposure was 414.0 (131.8) days (UC, 416 132; CD, 407 131); 89 (17.8%) pts had at least 1 additional dose (UC, 69 16.9%; CD, 20 22.0%) and 347 (69.4%) missed at least 1 VDZ dose (UC, 284 69.4%; CD, 63 69.2%). For patients with additional dose of VDZ, 12 pts (2.9%) with UC and 11 (12.1%) with CD received an additional VDZ dose at W10. Thirty-four pts (9.0%) with UC and 5 (5.6%) with CD received dose escalation from every 8 weeks (Q8W) to every 4 weeks (Q4W) after W14. In UC pts with an additional dose at W10, the clinical response and remission rates at W14 were 66.7% (6/9) and 66.7% (6/9), respectively. In CD pts with an additional dose at W10, the clinical response and clinical remission at W14 were 22.2% (2/9) and 88.9% (8/9), respectively. In pts with dose escalation Q4W, 61.5%, 69.2% and 71.4% of pts with UC achieved clinical response, while clinical remission rates were 53.9%, 73.1% and 81.8% at W14, W30 and W54, respectively (Figure 1). In pts with dose escalation Q4W, 1/3 (33.3%), 2/3 (66.7%), and 2/3 (66.7%) pts with CD achieved clinical response at W14, W30, and W54, respectively; while all pts achieved clinical remission at all time points. Moreover, 80 (19.6%) pts with UC and 13 (14.3%) pts with CD were reported to have concomitant steroid use at baseline. In these pts, steroid free clinical remission rates at W14 and W54 were 23/61 (37.7%) and 20/33 (60.6%) in pts with UC; 3/9 (33.3%) and 6/7 (85.7%) in pts with CD, respectively. Conclusion The VALUE study showed that VDZ dose escalation is limited in China and these results indicate potential benefits of this approach in treating pts with IBD. References: 1. Huang K, Liu J, Xia W, et al. Front Pharmacol. 2023;14:1188751. 2. Yang H, Huang Z, Li M, Zhang H, et al. EClinicalMedicine. 2023;66:102337. Conflict of interest: Zong, Ye: I have received research funding from Takeda (China) Zhong, Lan: I have received research funding from Takeda (China). Liu, Xin: I have received research funding from Takeda (China). Gu, Lifei: I am affiliate of Takeda (China) International Trading Co. Ltd. Mrs. Zhou, Fang: Employee of Takeda (China) International Trade Co., Ltd Chen, Minhu: I have received speaker honoraria from Takeda China, Xian Janssen, and AbbVie China, as well as research funding from Takeda (China).
Zong et al. (Thu,) studied this question.