Introduction
Vedolizumab (VDZ) is a monoclonal antibody therapy approved in China in 2020 for the treatment of patients with inflammatory bowel disease (IBD; Crohn's disease [CD] and ulcerative colitis [UC])2 who were intolerant to conventional therapies.1 VDZ has a unique, gut-selective, anti-lymphocyte trafficking (GSALT) mechanism of action.3 However, data on the efficacy and safety of VDZ in Chinese patients with IBD in the real-world setting are limited.4 This study evaluated the safety of VDZ in adult patients with IBD.
Aims & Methods
VALUE (NCT04872491) was a multicenter, single-arm, prospective, observational study to evaluate the safety of VDZ in adult Chinese patients with IBD (N=500) over a maximum observation period of 72 weeks. Incidence of adverse events (AEs), serious AEs (SAEs), treatment-related adverse drug reactions (ADRs), and AEs of special interest (AESIs) was evaluated. This was the final analysis of the VALUE study conducted in patients with IBD.
Results
A total of 500 patients (UC: n=409; CD: n=91) received VDZ 300 mg. Mean (±standard deviation) age of patients was 44.3 (±15.2) years, and 61.4% (n=307) were male. The mean duration for VDZ exposure was 414 days (UC: 416 days; CD:407 days). A total of 500 patients developed 674 AEs (Table), and the most frequent AEs were infections and infestations (I&I; UC: 115 [28.1%]; CD: 24 [26.4%]), followed by gastrointestinal disorders (GIDS; UC: 87 [21.3%]; CD: 18 [19.8%]). Incidence rates of AEs (/patient-years) were 1.2 and 1.0 in patients with UC and CD, respectively. Overall, 13 (3.2%) patients with UC and 10 (11.0%) with CD had AEs leading to study discontinuation. SAEs were observed in 78 patients with UC and 18 with CD (Table). A total of 19 AESIs were reported by patients with UC and 9 AESIs by those with CD, with the most common AESIs being I&I (UC: 13 [3.2%]; CD: 4 [4.4%]) and malignancy (UC: 3 [0.7%], CD: 2 [2.2%]). The most common I&I disorders reported by patients with UC and CD were Clostridium difficileinfection (4 [1.0%]) and pneumonia (1 [1.1%]), respectively. Overall, 17 (4.2%) patients with UC and 7 (7.7%) with CD had at least 1 AESI. A total of 91 and 15 treatment-related ADRs were observed in patients with UC and CD, respectively; I&I were the most frequently documented ADRs to VDZ treatment (Table). A total of 10 (UC: 5 [1.2%]; CD: 5 [5.5%]) patients treated under concomitant IBD advanced therapy (CIBDAT) experienced a total of 16 AEs (UC: 9; CD: 7), with the most common AEs being I&I (UC: 1 [20.0%]; CD: 2 [40.0%]) and GIDS (UC: 3 [60.0%]; CD: 1 [20.0%]) with CIBDAT. No deaths were reported during the study.
| UC | CD |
All reported AEs (n)
| 569
| 105
|
Mild/Moderate AEs, n (%)
| 379 (66.6)/140 (24.6)
| 73 (69.5)/18 (17.1)
|
Severe AEs, n (%)
| 50 (8.8)
| 14 (13.3)
|
SAEs (n)
| 78
| 18 |
Mild/Moderate, n (%)
| 8 (10.3)/31 (39.7) | 1 (5.6)/4 (22.2)
|
Severe, n (%)
| 39 (50.0)
| 13 (72.2)
|
Treatment-related ADRs (n)
| 91
| 15 |
I&I, n (%, 95%CI)
| 16 (3.9, 2.3-6.3)
| 2 (2.2, 0.3-7.7)
|
GIDS, n (%, 95%CI)
| 16 (3.9, 2.3-6.3)
| 1 (1.1, 0.03-6.0)
|
Conclusion
The VALUE study indicated that VDZ was well tolerated in Chinese patients with IBD, with no new safety concerns.
References
- Scribano ML. World J Gastroenterol. 2018; 24: 2457-2467.
- Yamamoto S et al., Cureus. 2024;16: e59691.
- Soler D et al. J Pharmacol Exp Ther. 2009; 330: 864-875.
- Baili C et al. Am J Gastroenterol. 2023; 118: S213-S214.
Disclosure
This study was funded by Takeda (China) International Trading Co. Ltd. Li Li, Haiyan Zhang, Chengxia Liu, and Xiaomei Sun have no conflicts of interest. Xiaoyu Qian and Fang Zhou are Takeda employees and hold Takeda stock options. Minhu Chen received speaker honorariums from Takeda China, AstraZeneca China, Xian Janssen, and Eisai China.
Medical writing support for the development of this abstract under the direction of the authors was provided by Vibhuti Singh, Ph.D., of Cactus Life Sciences (part of Cactus Communications), funded by Takeda (China) International Trading Co., Ltd.
