P4277 - Prospective, Multicenter, Single-Armed Observational Study to Evaluate the Safety of Vedolizumab in the Chinese Patients with Inflammatory Bowel Disease: Interim Analysis of Safety Results

Xiaohua Hou, ¹, Xiaowei Liu, ², Lifei Gu, ³, Li Xie, ⁴, Minhu Chen, MD, PhD^5
1Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China; ²Xiangya Hospital Affiliated to Zhongnan University, Hunan, Hunan, China; ³Takeda Pharmaceutical Company, Shanghai, Shanghai, China; ⁴Takeda Pharmaceutical Company Ltd., Shanghai, Shanghai, China; ⁵The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Introduction: Crohn's disease (CD) and ulcerative colitis (UC) are classified as inflammatory bowel disease (IBD) usually treated by conventional therapy and advanced therapy. Vedolizumab (VDZ), an advanced therapy with unique gut-selective anti-lymphocyte trafficking MOA was approved to treat moderate-to-severe Ulcerative Colitis (UC) and Crohn’s disease (CD) patients (pts) in 2020.

Methods: This multi-center, observational study enrolled 500 IBD Chinese patients aged ≥18 years. This study evaluated the safety and effectiveness of VDZ in patients with IBD during a maximum of 72 weeks observation period. Incidence of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADR) and AEs of special interest (AESIs) were evaluated. Here, we present the safety results of second interim analysis which was planned as 2 years after enrolling first patient (data cutoff: 21 October, 2023; NCT04872491)

Results: A total of 500 patients (UC: n=409; CD: n=91) with a median age of 43 years were included, of which 308 were males. Median duration was 420 days (UC: 414 days; CD:441 days) for VDZ exposure. 477 AEs and 92 AEs were observed in UC and CD groups with mild proportion ranked first in both the groups. Infections and infestations (I&I) were the most frequent AEs in both UC and CD with occurrence of 104(25.43%) and 24(26.37%), respectively, followed by gastrointestinal disorders (GIDs) with that of 80(19.56%) and 18(19.78%), respectively (Figure 1). Overall, 79 and 14 ADRs were reported in UC and CD respectively. 11 (2.69%) UC patients and 9 (9.89%) CD patients had AEs lead to study discontinuation, respectively. 68 and 19 SAEs were observed in UC and CD. Furthermore, 17(4.16%) and 7(7.69%) patients had at least one AESI and the most common AESI was infection (UC: 13, 3.18%; CD:5, 5.49%) and malignancy (UC 3, 0.73%, CD 2, 2.20%). Clostridium difficile infection was the most occurred infections in UC group reported by 4 patients of which 2 were mild, 1 was moderate and 1 was severe. No death was observed during the study (Table 2). During study observational phase, both 4 patients in UC and CD group reported a concomitant treatment of IFX, UST or TOF. In these patients, 7 AEs were reported in UC and 5 AEs were reported in CD with no AE leading to study discontinuation or death were observed.

Discussion: VDZ demonstrated a good safety profile among Chinese adult patients with IBD in a real world setting.



Disclosures:


Xiaohua Hou, ¹, Xiaowei Liu, ², Lifei Gu, ³, Li Xie, ⁴, Minhu Chen, MD, PhD⁵. P4277 - Prospective, Multicenter, Single-Armed Observational Study to Evaluate the Safety of Vedolizumab in the Chinese Patients with Inflammatory Bowel Disease: Interim Analysis of Safety Results, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.