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

ABSTRACT: 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

SUBMITTER: Fang L 

PROVIDER: S-EPMC12141155 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature