一日一次高剂量醋酸茚达特罗/格隆溴铵/糠酸莫米松和高剂量醋酸茚达特罗/糠酸莫米松在日本哮喘控制不佳患者中的长期安全性：两项开放标签、为期52周研究的结果

Long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate high-dose, and indacaterol acetate/mometasone furoate high-dose, in Japanese patients with inadequately controlled asthma: Results from two open-label, 52-week studies.

作者信息

Sagara Hironori, D'Andrea Peter, Tanase Ana-Maria, Pethe Abhijit, Tanaka Yukina, Matsuo Kazutaka, Hosoe Motoi, Nakamura Yoichi

机构信息

Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University, School of Medicine, Tokyo, Japan.

Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

出版信息

J Asthma. 2023 Feb;60(2):403-411. doi: 10.1080/02770903.2022.2056048. Epub 2022 May 30.

DOI:10.1080/02770903.2022.2056048

PMID:35348408

Abstract

INTRODUCTION

The 52-week long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF) high-dose (150/50/160 µg) and IND/MF high-dose (150/320 µg) was evaluated in two studies enrolling Japanese patients with inadequately controlled asthma.

METHODS

Study 1 (IND/GLY/MF) and Study 2 (IND/MF) were 52-week, phase III, open-label, single-arm, multicenter studies conducted in Japanese adult patients with inadequately controlled asthma. The primary endpoint was incidence and severity of treatment-emergent adverse events (AEs) over 52-weeks.

RESULTS

In Study 1, 94 patients received IND/GLY/MF high-dose and 84 (89.4%) patients completed the 52-week study treatment; in Study 2, 51 patients received IND/MF high-dose and 48 (94.1%) patients completed the 52-week study treatment. In Study 1, 68.1% and 6.4% of 94 patients reported ≥1 AE and ≥1 serious AE (SAE) respectively. In Study 2, 78.4% of 51 patients reported ≥1 AE; no patients reported SAEs. The most commonly reported AEs were asthma (exacerbation; 30.9% and 54.9%) and nasopharyngitis (18.1% and 29.4%) in Study 1 and Study 2, respectively. Severe AEs including asthma (exacerbation) were reported in 13.8% and 13.7% of patients in Study 1 and Study 2, respectively. In Study 1, 10 patients (10.6%) reported treatment-related AEs, of which dysphonia (9 patients [9.6%]) was the most commonly reported; no treatment-related AEs were reported in Study 2. In Study 1, one death (not study drug-related) was reported after study discontinuation (92 days after last dose of study medication).

CONCLUSIONS

Once-daily IND/GLY/MF and IND/MF high-dose were well-tolerated in Japanese patients with inadequately controlled asthma. No unexpected safety findings were observed.

UNLABELLED

Supplemental data for this article is available online at.

摘要

引言

在两项纳入哮喘控制不佳的日本患者的研究中，评估了每日一次的高剂量茚达特罗乙酸盐/格隆溴铵/糠酸莫米松（IND/GLY/MF，150/50/160μg）和高剂量IND/MF（150/320μg）的52周长期安全性。

方法

研究1（IND/GLY/MF）和研究2（IND/MF）为52周、III期、开放标签、单臂、多中心研究，在哮喘控制不佳的日本成年患者中进行。主要终点是52周内治疗中出现的不良事件（AE）的发生率和严重程度。

结果

在研究1中，94例患者接受了高剂量IND/GLY/MF治疗，84例（89.4%）患者完成了52周的研究治疗；在研究2中，51例患者接受了高剂量IND/MF治疗，48例（94.1%）患者完成了52周的研究治疗。在研究1中，94例患者中分别有68.1%和6.4%报告了≥1次AE和≥1次严重AE（SAE）。在研究2中，51例患者中有78.4%报告了≥1次AE；无患者报告SAE。研究1和研究2中最常报告的AE分别是哮喘（加重；30.9%和54.9%）和鼻咽炎（18.1%和29.4%）。研究1和研究2中分别有13.8%和13.7%的患者报告了包括哮喘（加重）在内的严重AE。在研究1中，10例患者（10.6%）报告了与治疗相关的AE，其中声音嘶哑（9例[9.6%]）是最常报告的；研究2中未报告与治疗相关的AE。在研究1中，研究停药后（最后一剂研究药物后92天）报告了1例死亡（与研究药物无关）。