Scholarlink

<p>Avatrombopag is an oral thrombopoietin receptor agonist approved widely for the treatment of adults with chronic immune thrombocytopenia (ITP). However, data in Japanese patients are limited. This confirmatory phase 3, open-label study investigated avatrombopag (initial dose 20&#xa0;mg/day) in Japanese adults (aged ≥ 18&#xa0;years) with chronic ITP (≥ 12&#xa0;months), insufficient response to prior treatment and an average of 2 platelet counts (PCs) &lt; 30 × 10<sup>9</sup>/L. The primary endpoint was the cumulative number of weeks of platelet response (PC ≥ 50 × 10<sup>9</sup>/L) without rescue therapy for bleeding. Secondary endpoints included platelet response rate at Day 8 and safety. In total, 19 patients were enrolled into the 26-week core phase. The mean age was 56.0&#xa0;years; 78.9% of patients were female. Mean cumulative number of weeks of platelet response was 13.5 (95% CI 9.1–17.8). Platelet response at Day 8 was achieved by 63.2% of patients. In the core phase, adverse events (AEs) occurred in 94.7% of patients and serious AEs in 15.8%. No thromboembolic events or deaths occurred in the core phase. Avatrombopag demonstrated a rapid and durable platelet response and was well tolerated in Japanese patients with chronic ITP. Long-term safety and efficacy are being assessed in the ongoing extension phase.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

A phase 3 study of the efficacy and safety of avatrombopag in Japanese adults with chronic immune thrombocytopenia

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年5月20日

查看全文
  • Hiroki Yamaguchi,
  • Masaki Iino,
  • Shugo Kowata,
  • Ryusuke Yamamoto,
  • Jun Yamanouchi,
  • Yutaka Imamura,
  • Keita Kirito,
  • Kenji Yokoyama,
  • Tomoki Ito,
  • Tatsunori Ishikawa,
  • Motoaki Shiratsuchi,
  • Yoshiaki Tomiyama,
  • Harumi Kamiya,
  • Jessica Zhang,
  • Brian D. Jamieson

摘要

Avatrombopag is an oral thrombopoietin receptor agonist approved widely for the treatment of adults with chronic immune thrombocytopenia (ITP). However, data in Japanese patients are limited. This confirmatory phase 3, open-label study investigated avatrombopag (initial dose 20 mg/day) in Japanese adults (aged ≥ 18 years) with chronic ITP (≥ 12 months), insufficient response to prior treatment and an average of 2 platelet counts (PCs) < 30 × 109/L. The primary endpoint was the cumulative number of weeks of platelet response (PC ≥ 50 × 109/L) without rescue therapy for bleeding. Secondary endpoints included platelet response rate at Day 8 and safety. In total, 19 patients were enrolled into the 26-week core phase. The mean age was 56.0 years; 78.9% of patients were female. Mean cumulative number of weeks of platelet response was 13.5 (95% CI 9.1–17.8). Platelet response at Day 8 was achieved by 63.2% of patients. In the core phase, adverse events (AEs) occurred in 94.7% of patients and serious AEs in 15.8%. No thromboembolic events or deaths occurred in the core phase. Avatrombopag demonstrated a rapid and durable platelet response and was well tolerated in Japanese patients with chronic ITP. Long-term safety and efficacy are being assessed in the ongoing extension phase.