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 reduce intestinal tissue inflammation. VDZ was approved to treat moderate-to-severe Ulcerative Colitis (UC) and Crohn’s disease (CD) patients (pts) in 2020 in China, however, the effectiveness and safety data of VDZ in Chinese inflammatory bowel disease (IBD) pts is lacking.
Methods: VALUE study is a prospective, multicenter, single-armed observational study to evaluate the safety and effectiveness of VDZ in Chinese population, with a study sample size of 750 IBD pts. Two interim analyses were planned to conduct at one and two years after first patient enrollment. This is the first interim analysis in CD pts. A descriptive summary was provided for demographic and baseline characteristics, safety, and effectiveness.
Results: Totally 62 CD pts were enrolled in this interim analysis with a median CD duration of 731 days. Among pts having Harvey-Bradshaw index (HBI) score, the mean (±SD) was 5.4 (±3.7), and 27.7% (13/47) of them had moderate-to-severe CD. Most CD pts were ileocolonic (51.6%), 11.3% (7/62) had CD-related surgery, and 50.0% (31/62) had prior biologic use (Table).
After initiation of VDZ treatment, the HBI mean (±SD) score decreased from 5.4 (±3.7) to 3.2 (±2.3) and 3.1 (±1.3) at week 14 and 30, respectively (Figure). 34.5% (10/29) and 4 of 10 pts achieved clinical response at week 14 and 30, respectively; 79.3% (23/29) and 90.9% (10/11) pts achieved clinical remission at week 14 and 30, respectively (Figure). For pts with prior biologic use, 3 of 10 and 1 of 4 pts achieved clinical response at week 14 and 30, 9 of 10 and 3 of 4 pts achieved clinical remission at week 14 and 30, respectively. For pts without prior biologic use, 36.8% (7/19) and 3 of 6 pts achieved clinical response at week 14 and 30, 73.7% (14/19) and 7 of 7 pts achieved clinical remission at week 14 and 30, respectively (Figure). For moderate-to-severe CD pts (defined as baseline HBI score＞7), 6 of 8 and 2 of 2 pts achieved clinical response at week 14 and 30, 5 of 8 and 2 of 2 pts achieved clinical remission at week 14 and 30, respectively. Most adverse events (AEs) during the treatment were mild (79.4%), 6.5% of pts had AEs leading to study discontinuation. No new safety signals were observed.
Discussion: This study showed VDZ was an effective therapy for the management of Chinese CD patients. The safety findings in this study remain in line with the known safety profile of VDZ.
Figure: Figure: (A) Mean HBI score at baseline, week 14 and week 30. The error bars represent one SD, (B) Clinical outcomes of CD patients after 14, 30 weeks of VDZ therapy. HBI: Harvey-Bradshaw index. a: Clinical response defined as ≥3-point decrease in the HBI score; b: Clinical remission defined as HBI score of ≤4.
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. P3019 - Clinical Effectiveness of Vedolizumab in Chinese Crohn's Disease Patients: Results From the VALUE Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
