P990 A Multi-center, Single-arm, Prospective, Observational, Real-world Study in China to Evaluate Effectiveness of Vedolizumab in the Treatment of Inflammatory Bowel Diseases: First Interim Analysis of Patient-reported Outcomes

Abstract

Abstract Background Crohn’s disease (CD) and ulcerative colitis (UC) are types of inflammatory bowel disease (IBD), causing abdominal pain, diarrhea, rectal bleeding and weight loss which is concerning due to increased prevalence and morbidity. As IBD affects quality of life (QoL), improving it is a major treatment goal. Current therapy in IBD includes corticosteroids, immunomodulators, biologics, small molecule drugs, etc. Vedolizumab (VDZ), a gut-specific antibody against α4β7 integrin, is approved in China in moderate to severe UC/CD treatment. This multi-center, single arm, prospective, observational, real-world study (NCT04872491) evaluated safety and effectiveness of VDZ in Chinese UC/CD patients. This first interim analysis presented changes in symptomatic relief and QoL. Safety results are shown separately. Methods Enrolled UC/CD patients (>18 years) were treated with 300 mg VDZ by intravenous infusion at week 0, 2, 6, and every 8 weeks till 54 weeks. At data cut-off (October 21, 2022), 307 patients were assessed for symptomatic relief and QoL by patient reported outcomes (PRO) scores, partial Mayo score rectal bleeding sub-score [RBS], stool frequency sub-score [SFS]) in UC; abdominal pain sub-score [APS], loose stool frequency sub-score [LSFS]) in CD at days 3, 7 and 14 and IBD questionnaire (IBDQ), EuroQol-5-Dimension-5-Level index (EQ-5D-5L) and EQ-visual analog scale (VAS) scores in UC and CD from baseline to week 14. Descriptive statistics summarized the effectiveness. Results Of 265 patients (UC: 211, CD: 54) analysed for effectiveness, 62.9% were males with mean(±SD) age 43.1±15.0 years and median IBD duration of 883 days. At baseline, mean(±SD) for partial Mayo and HBI scores were 5.185±1.936 and 5.362±3.674 for UC and CD patients respectively. Compared to baseline, UC patients showed significant difference in RBS and SFS scores from days 3 and 7 respectively reflecting rapid onset effect of VDZ (Figure 1). Patients with RBS=0 and SFS≤1 scores improved from 34.78% at baseline to 62.79% at day 14 after treatment. IBDQ, EQ-5D-5L and EQ-VAS mean±SD score changes of 38.853±39.569, 0.046±0.125 and 10.258±14.756 signified improved QoL (Table 1). At baseline, mean±SD APS and LSFS scores in CD patients were 0.692±0.832 and 1.462±1.570 (n=39), which decreased to 0.425±0.594 and 1.325±1.207 (n=40) at day 14 with a mean change of -0.211±0.528 and -0.105±0.981 (Figure 1). VDZ effectively maintained remission in patients with APS≤1 and LSFS≤3 which increased from 35.90% at baseline to 50.00% at day 14. Improved QoL was observed with changes in IBDQ (13.194±31.592) (Table 1). Conclusion VDZ effectively improved and maintained symptomatic relief and QoL in Chinese UC/CD patients in real-world settings.