S1739 Vedolizumab Demonstrated Effectiveness in Improving Symptom Relief and Quality of Life in Chinese Patients With Ulcerative Colitis: Results From the Real-World VALUE Study

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. Inflammatory bowel disease (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 men; 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 tumor necrosis factor (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. 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. Conclusion: Vedolizumab treatment was associated with significant symptomatic relief and improved QoL in patients with UC in real-world clinical settings in China.