The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China
Baili Chen, MD1, Li Xie, PhD2, Yameng Liu, PhD2, Minhu Chen, MD1 1The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China; 2Takeda Pharmaceutical Company, Beijing, Beijing, China
Introduction: Vedolizumab (VDZ) is a gut-selective anti-lymphocyte trafficking (GSALT) biologic, which binds to the α4β7 integrin and reduces intestinal tissue inflammation. VDZ was approved to treat moderate to severe Ulcerative Colitis (UC) and Crohn's disease (CD) patients (pts) in China in 2020; however, the effectiveness and safety of VDZ in Chinese Inflammatory bowel disease (IBD) pts are lacking.
Methods: VALUE study is a prospective, multicenter, single-armed observational study to evaluate the safety and effectiveness of VDZ in the Chinese population, with a study sample size of 750 IBD pts. This study evaluated the safety of VDZ in adult IBD pts during a maximum of 72-week observation period; and the effectiveness of VDZ, including clinical response, clinical remission, and endoscopic remission, at week 14, 30 and 54. Two interim analysis for safety and effectiveness monitoring purposes were planned. This is the first interim analysis in UC pts. A descriptive summary was provided for demographic and baseline characteristics, safety, and effectiveness.
Results: Totally 245 UC pts were enrolled in this interim analysis. 86.12% (211/245) UC pts were included in the effectiveness analysis set. The mean age was 45.6 years old. 60.82% (149/245) pts were male. Most UC pts were extensive UC (48.16%). The median duration of UC was 1035 days. 10.61% (26/245) pts had prior biologic use, the Partial Mayo mean (±SD) score was 5.185 (±1.936) (Table).
After initiation of VDZ treatment, 79.19% (118/149) and 82.09% (55/67) pts achieved clinical response at week 14 and 30, respectively. 66.89% (101/151) and 71.64% (48/67) pts achieved clinical remission at week 14 and 30, respectively. 76.32% (29/38) and 76.47% (13/17) pts achieved endoscopic remission at week 14 and 30, respectively. 26.32% (10/38) and 29.41% (5/17) pts achieved complete endoscopic remission at week 14 and 30, respectively (Figure). At week 54, 2 of 2 pts achieved clinical remission and 1 of 1 pts achieved complete endoscopic remission. The performance of VDZ in the subgroup population was similar to that of the overall population, and both had promising efficacy (Figure). Most (70.16%) of adverse events during the treatment were mild, 2.04% of patients had adverse events leading to study discontinuation, and no new safety signals were observed.
Discussion: Vedolizumab was effective and well tolerated in Chinese UC pts in the real-world setting. Further studies are needed to consolidate this result.
Figure: Figure: Clinical outcomes of UC patients after 14 and 30 weeks of VDZ therapy. a: Clinical response defined as ≥2 points reduction in Partial Mayo Clinic score and ≥25% decrease from baseline score accompanied with ≥1-point decrease in rectal bleeding sub-score or absolute rectal bleeding sub-score ≤1; b: Clinical remission defined as Partial Mayo Clinic score ≤2 with no sub-score >1; c: Endoscopic remission defined as Mayo endoscopic sub-score ≤1; d: Complete endoscopic remission defined as Mayo endoscopic sub-score of 0.
Disclosures:
Baili Chen indicated no relevant financial relationships.
Li Xie: Takeda Pharmaceutical Company – Employee, Stock Options.
Yameng Liu: Takeda Pharmaceutical Company – Employee.
Minhu Chen: AstraZeneca China – Speaker Honorarium. Eisai China – Speaker Honorarium. Takeda China – Speaker Honorarium. Xian Janssen – Speaker Honorarium.
Baili Chen, MD1, Li Xie, PhD2, Yameng Liu, PhD2, Minhu Chen, MD1. P3020 - Clinical Effectiveness of Vedolizumab in Chinese Ulcerative Colitis Patients: Results From the VALUE Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
