P3259 - First Interim Analysis of Safety and Effectiveness on Elderly Patients in View Study: A Multicenter, Single-Arm, Prospective, Non-Interventional Study on Vonoprazan in the Real-world Clinical Practice in China

Yinglian Xiao, DM¹, Hongwei Xu, MD², Li Yang, MD³, Amy Nail, PhD⁴, Qi Song, MD⁵, Li Xie, PhD⁶, Minhu Chen, MD^7
1The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China; ²Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jiang, Shandong, China; ³West China Hospital of Sichuan University, Chengdu, Sichuan, China; ⁴Takeda, Cambridge, MA; ⁵Takeda Pharmaceutical Company, Shanghai, Shanghai, China; ⁶Takeda Pharmaceutical Company, Beijing, Beijing, China; ⁷The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Introduction: Vonoprazan, a novel potassium competitive acid blocker, was approved in China for the treatment of reflux esophagitis (RE) in 2019. Data is needed on the safety of treatment in elderly patients (≥65 years) due to their physical frailty and aging immunity. VIEW (NCT04501627) is a multi-center, single-arm, prospective, observational study conducted to provide data on the safety and effectiveness of vonoprazan in real-world clinical practice for Chinese patients. We present the first interim analysis results for elderly patient subset.

Methods: Patients were treated with 20 mg vonoprazan orally QD for 4 weeks (8 weeks if insufficient healing). The primary safety endpoint was incidence rate of adverse events (AEs), assessed till 2 weeks post-treatment, and classified by severity and system organ class. Secondary effectiveness endpoints include, from the gastroesophageal reflux disease (GERD) questionnaire (GerdQ), the percentage of patients without GERD-typical symptoms at baseline and week 4, and the change in GerdQ score from baseline to week 4. Effectiveness endpoints from the Diary of Typical Symptoms include the percentage of patients with complete relief of heartburn, night-time heartburn, regurgitation, and night-time regurgitation, during the first week of treatment.

Results: Of 1012 enrolled patients, 118 and 83 patients, age ≥ 65 years were in the safety and effectiveness analyses (EAS) sets, respectively. At least one mild, moderate or severe AE, respectively, was reported in only 25.4%, 3.4% and 2.5% of these patients, and the system organ class breakdown is given in Table 1. In the EAS, the percentage of patients without GERD-typical symptoms increased from 24% (95% CI: 16%, 35%) at baseline to 66% (95% CI: 53%, 77%) at week 4. For 69 patients with total GerdQ scores at both baseline and week 4, the mean ± SD of the difference was -1.9 ± 3.1 (95% CI: -2.6, -1.1). Negative values represent improvement. Of patients presenting at enrollment with heartburn, night-time heartburn, regurgitation, or night-time regurgitation, the percentage who had complete symptom relief in the first week of treatment were 35% (95% CI: 22%, 50%), 49% (95% CI: 34%, 64%), 28% (95% CI: 16%, 43%), and 44% (95% CI: 30%, 59%), respectively.

Discussion: In real-world clinical practice, vonoprazan is well-tolerated and effectively relieved RE symptoms in elderly Chinese patients.


Disclosures:


Yinglian Xiao, DM¹, Hongwei Xu, MD², Li Yang, MD³, Amy Nail, PhD⁴, Qi Song, MD⁵, Li Xie, PhD⁶, Minhu Chen, MD⁷. P3259 - First Interim Analysis of Safety and Effectiveness on Elderly Patients in View Study: A Multicenter, Single-Arm, Prospective, Non-Interventional Study on Vonoprazan in the Real-world Clinical Practice in China, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.