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Long-term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia
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Long-term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia
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Long-term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia
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Journal Article
Long-term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia
2025
Overview
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.
Publisher
Springer Nature B.V,Springer Nature Singapore
Subject
/ Aged
/ COVID-19
/ Diarrhea
/ Enzymes
/ Female
/ Humans
/ Idiopathic thrombocytopenic purpura
/ Japan
/ Kinases
/ Male
/ Nitriles
/ Oxazines - administration & dosage
/ Patients
/ Purpura, Thrombocytopenic, Idiopathic - blood
/ Purpura, Thrombocytopenic, Idiopathic - drug therapy
/ Pyridines - administration & dosage
/ Safety
