P3258 - First Interim Analysis of Safety and Effectiveness in View Study: A Multicenter, Single-Arm, Prospective, Non-Interventional Study of Vonoprazan in Real-World Clinical Practice in China

Award: Presidential Poster Award

Yinglian Xiao, DM¹, Yixia Lu, MD², Hui 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; ²Heilongjiang Provincial Hospital, Harbin, Heilongjiang, China; ³Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 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 with rapid action and potent acid inhibition, is approved in China for the first-line treatment of reflux esophagitis (RE). VIEW (NCT04501627) is a multicenter, single-arm, prospective, observational study, which aims to provide safety and effectiveness data on vonoprazan in a real-world setting, and aims to enrol 3000 Chinese patients over 44 sites. We present the first interim analysis results following the completion of at least 1000 patients.

Methods: All patients are treated with 20 mg vonoprazan orally QD for 4 weeks (8 weeks for insufficient benefit). Primary endpoints are incidence rates of adverse events (AEs), severe AEs (SAEs), and adverse drug reactions (ADRs). Secondary effectiveness endpoints include, from the gastroesophageal reflux disease (GERD) questionnaire (GerdQ), the percentages of patients without GERD-typical symptoms at baseline and week 4, and the change in GerdQ score from baseline to week 4, with negative value meaning improvement. Effectiveness endpoints from the Diary of Typical Symptoms include the percentages of patients with complete relief from heartburn, night-time heartburn, regurgitation, and night-time regurgitation for the first week of treatment.

Results: Of 1012 patients enrolled, 947 and 573 patients formed the safety and effectiveness analyses sets (SAS and EAS), respectively. The SAS had 59.6% men; age and BMI (mean ± SD) were 48.5±13.7 years and 23.6±3.8 kg/m², respectively. The percentages of patients in the SAS who reported one or more AE, SAE, ADR, or SADR were, respectively, 25.4, 0.7, 7.2, and 0.1. The percentages of patients in the SAS who had an AE leading to treatment or study discontinuation were 3.4 and 1, respectively. There were no patient deaths.

In the EAS, the percentage of patients without GERD-typical symptoms increased from 22.8 (95% CI: 19.4, 26.5) at baseline to 54.6 (49.9, 59.3) at week 4, with a change of 31.8% (26.1, 37.6). For the 448 patients with total GerdQ scores for baseline and week 4, the change (mean ± SD) was -1.5±2.8 (-1.8, -1.3): the point-estimate and both limits of the 95% CI represent improvement. The percentages of patients with complete symptom relief for heartburn, night-time heartburn, regurgitation, or night-time regurgitation in the first week of treatment were 35.0, 47.5, 30.0, and 43.0, respectively (Table 1).

Discussion: Vonoprazan is safe and effective in treating Chinese RE patients in real-world setting.


Disclosures:


Yinglian Xiao, DM¹, Yixia Lu, MD², Hui Yang, MD³, Amy Nail, PhD⁴, Qi Song, MD⁵, Li Xie, PhD⁶, Minhu Chen, MD⁷. P3258 - First Interim Analysis of Safety and Effectiveness in View Study: A Multicenter, Single-Arm, Prospective, Non-Interventional Study of Vonoprazan in Real-World Clinical Practice in China, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.