P3243 - Vedolizumab Demonstrated Effectiveness in Improving Symptom Relief and Quality of Life in Chinese Patients With Ulcerative Colitis: Results from the Real-World VALUE Study
Takeda Pharmaceutical Company, Shanghai, China Shanghai, Shanghai, China
Xiang Gao, MD1, Jinghua Hao, MD2, Xueli Ding, MD3, Lifei Gu, MSc4, Fang Zhou, MSc4, Minhu Chen, MD, PhD5 1The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, Guanzhou, Guangdong, China; 2Shandong Provincial Hospital Affiliated to Shandong First Medical University, Ji’nan, China, Ji`nan, Shandong, China; 3The Affiliated Hospital of Qingdao University, Qingdao, China, Qindago, Shandong, China; 4Takeda Pharmaceutical Company, Shanghai, China, Shanghai, Shanghai, China; 5The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China, Guangzhou, Guangdong, China Introduction: Vedolizumab, is a gut-selective humanized monoclonal antibody for α4β7 integrin, approved in China for patients with ulcerative colitis (UC) and Crohn’s disease. Using patient-reported outcomes, we assessed the real-world effectiveness of vedolizumab in improving symptomatic relief and quality of life (QoL) in Chinese patients with UC in the VALUE study. Methods: VALUE (NCT04872491) is a prospective, multicenter, single-arm, observational study. Enrolled patients with UC aged ≥18 years were treated with 300 mg vedolizumab by intravenous infusion at Weeks 0, 2, and 6, and every 8 weeks until 54 weeks. In this final analysis, rectal bleeding subscore (RBS) and stool frequency subscore (SFS) were assessed daily from baseline to Day 14. IBD questionnaire (IBDQ), EuroQoL 5-Dimension 5-Level (EQ‑5D-5L), and EuroQoL-Visual Analog Scale (EQ-VAS) scores were analyzed at baseline, Week 14, and Week 54. All analyses were descriptive. Results: Of the 409 enrolled patients with UC, 59.4% were male; 30.8% had moderate and 29.8% had severe UC at baseline. Mean (SD) age and disease duration were 46.3 (15.1) years and 4.5 (5.4) years, respectively. Mean (SD) Partial Mayo score at baseline was 5.1 (2.1) for 394 patients. Based on disease location, ulcerative proctitis (E1), left-sided UC (E2), and extensive UC (E3) were observed in 14.2%, 25.9%, and 53.1% of patients, respectively. Of the enrolled patients, 41 (10.0%) received prior TNF-α inhibitor therapy: 37 (9.1%) and 5 (1.2%) received infliximab and adalimumab treatment, respectively. In addition, 87.3% of patients had ≥1 concomitant IBD medication, which included 5-ASA (78.7%) and steroids (26.2%). In the effectiveness analysis set (n=376), symptomatic improvement was observed with mean (95% CI) change from baseline to Day 14 in RBS and SFS at −0.5 (−0.6, −0.4) for both (Figure 1). Significant changes from baseline were achieved as early as Day 3 for RBS (−0.1 [−0.17, −0.04]) and Day 4 for SFS (−0.1 [−0.19, −0.02]). The percentage of patients with RBS=0 and SFS≤1 increased from 34.9% at baseline to 64.2% on Day 14. QoL improved with mean (SD) change in total scores from baseline to Week 14 and to Week 54 for IBDQ at 36.4 (37.9) and 39.5 (37.8), for EQ-5D-5L at 0.05 (0.1) and 0.07 (0.2), and for EQ-VAS at 9.1 (15.8) and 10.8 (16.1), respectively (Table 1). Discussion: Vedolizumab treatment was associated with significant symptomatic relief and improved QoL in patients with UC in real-world clinical settings in China.
Figure: Figure 1: Mean RBS and SFS from baseline to Day 14 in patients with UC
Figure: Table 1. IBDQ, EQ-5D-5L, and EQ-VAS scores at baseline, Week 14, and Week 54 for patients with UC
Xiang Gao, MD1, Jinghua Hao, MD2, Xueli Ding, MD3, Lifei Gu, MSc4, Fang Zhou, MSc4, Minhu Chen, MD, PhD5. P3243 - Vedolizumab Demonstrated Effectiveness in Improving Symptom Relief and Quality of Life in Chinese Patients With Ulcerative Colitis: Results from the Real-World VALUE Study, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.
