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<p>A prospective, single-arm, open-label Phase III clinical trial was conducted across multiple centers in China from April 27, 2020, to June 15, 2021, to assess the efficacy and safety of 10% intravenous immunoglobulin (IVIg) in treating adult immune thrombocytopenic purpura (ITP). Within 7&#xa0;days of treatment initiation, the 10% IVIg group exhibited an overall response rate of 87.0%, with 32 patients (46.4%) achieving complete response and 28 patients (40.6%) demonstrating partial response, comparable to the 5% IVIg group. Notably, the median time to achieve a platelet count (PLT) of 50 × 10<sup>9</sup>/L was significantly shorter for the 10% IVIg group at 2&#xa0;days (IQR: 2–3) versus 3&#xa0;days (IQR: 3–5) for the 5% IVIg group. Additionally, the 10% IVIg group reached a PLT of 100 × 10<sup>9</sup>/L in 3&#xa0;days (IQR: 3–4), compared to 5&#xa0;days (IQR: 4–6) for the 5% IVIg group. Post-treatment bleeding scores significantly decreased, and no significant adverse reactions were reported. This inaugural study highlights the efficacy and safety of 10% IVIg in the urgent management of adult ITP, positioning it as a rapid therapeutic option.</p>

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Efficacy and safety analysis of China’s first 10% IVIg (RonsenGlob) therapy in treating adult ITP

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月10日

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  • Lijun Fang,
  • Ting Sun,
  • Hu Zhou,
  • Guitao Jie,
  • Jiaping Fu,
  • Enqin Yang,
  • Zeping Zhou,
  • Ligen Liu,
  • Jingyu Zhang,
  • Shenxian Qian,
  • Yun Chen,
  • Ling Liu,
  • Jian Gu,
  • Fanliang Kong,
  • Ruibin Huang,
  • Yunfei Chen,
  • Lei Zhang

摘要

A prospective, single-arm, open-label Phase III clinical trial was conducted across multiple centers in China from April 27, 2020, to June 15, 2021, to assess the efficacy and safety of 10% intravenous immunoglobulin (IVIg) in treating adult immune thrombocytopenic purpura (ITP). Within 7 days of treatment initiation, the 10% IVIg group exhibited an overall response rate of 87.0%, with 32 patients (46.4%) achieving complete response and 28 patients (40.6%) demonstrating partial response, comparable to the 5% IVIg group. Notably, the median time to achieve a platelet count (PLT) of 50 × 109/L was significantly shorter for the 10% IVIg group at 2 days (IQR: 2–3) versus 3 days (IQR: 3–5) for the 5% IVIg group. Additionally, the 10% IVIg group reached a PLT of 100 × 109/L in 3 days (IQR: 3–4), compared to 5 days (IQR: 4–6) for the 5% IVIg group. Post-treatment bleeding scores significantly decreased, and no significant adverse reactions were reported. This inaugural study highlights the efficacy and safety of 10% IVIg in the urgent management of adult ITP, positioning it as a rapid therapeutic option.