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<p>Fostamatinib had superior efficacy to a placebo and acceptable safety profiles for at least 1 year in a phase 3 study of Japanese patients with primary immune thrombocytopenia. Here, we report the 3-year safety and efficacy of fostamatinib in that study. Data from 33 patients who received at least one dose of fostamatinib were analyzed. A platelet response &gt; 50,000/µL (at two consecutive visits at least 28&#xa0;days apart while receiving fostamatinib) was achieved in 16 patients (48%). The median total duration of a platelet response &gt; 50,000/µL was 589 (range: 106–1003)&#xa0;days. Gastrointestinal disorders, such as diarrhea, hypertension, and hepatic enzyme elevation, were the most common fostamatinib-related adverse events. Most events occurred within 12&#xa0;weeks of treatment. No thromboembolisms, treatment-related infections, or moderate or severe treatment-related bleeding events were observed. In summary, this extension study of a clinical trial found a sustained platelet response without new safety signals during 3-year treatment with fostamatinib.</p>

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Long-term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年1月28日

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  • Masataka Kuwana,
  • Yoshiaki Tomiyama

摘要

Fostamatinib had superior efficacy to a placebo and acceptable safety profiles for at least 1 year in a phase 3 study of Japanese patients with primary immune thrombocytopenia. Here, we report the 3-year safety and efficacy of fostamatinib in that study. Data from 33 patients who received at least one dose of fostamatinib were analyzed. A platelet response > 50,000/µL (at two consecutive visits at least 28 days apart while receiving fostamatinib) was achieved in 16 patients (48%). The median total duration of a platelet response > 50,000/µL was 589 (range: 106–1003) days. Gastrointestinal disorders, such as diarrhea, hypertension, and hepatic enzyme elevation, were the most common fostamatinib-related adverse events. Most events occurred within 12 weeks of treatment. No thromboembolisms, treatment-related infections, or moderate or severe treatment-related bleeding events were observed. In summary, this extension study of a clinical trial found a sustained platelet response without new safety signals during 3-year treatment with fostamatinib.