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Efficacy and safety analysis of China's first 10% IVIg (RonsenGlob) therapy in treating adult ITP
Lijun Fang1,2, Ting Sun1,2, Hu Zhou3
1State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin & CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, 300020, China.
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.
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.
