Prospective, Non-Randomized, Open-Label, Single-Arm, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Immunoglobulin 10% Formulation in Patients with Immune Thrombocytopenia (ITP)

• Published in: Blood 2016-12, Vol.128 (22), p.4938-4938
• Main Authors: Bang, Soo-Mee, Mun, Yeung-Chul, Shin, Ho-Jin, Jung, Chul Won, Bae, Sung Hwa, Sohn, Sang Kyun, Kim, Kyoung Ha, Kim, Hawk, Yhim, Ho-Young, Hong, Junshik, Kim, Hye Joo, Lee, Jae-hoon, Oh, Doyeun
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V128.22.4938.4938

This study investigated the safety and efficacy of IV-Globulin SN, a 10% intravenous immunoglobulin (IVIg), in patients with severe ITP (platelet count ¡Â20 x 109/L). Among 81 eligible patients, 31 patients were newly diagnosed, 7 patients had persistent ITP, and 43 patients had chronic ITP. Five patients had received splenectomy. Patients received IV-Globulin SN 1 g/kg/day on two consecutive days; infusion rate was initially 1 mg/kg/minute and then doubled every 30 minutes to a maximum of 8 mg/kg/minute. Fifty-eight patients (72%) attained the primary efficacy endpoint of clinical response (platelet count ¡Ã 50 x 109/L within 7 days). Their median time to response was 2 days and the median duration of response was 10 days (range from 1 to 28 days). Complete response (platelet count ¡Ã 100 x 109/L over 7 days) was obtained in 14 patients (17%). Response rates were not significantly different when compared the patients with newly diagnosed, persistent or chronic ITP; previous treatment with immunosuppressant or not; splenectomized or not. IV-Globulin SN 10% was well tolerated and the frequency of mucocutaneous bleeding was decreased during the study period (figure 1). There was no unexpected adverse event. The mean half-life and Cmax of study drug were 28.9 days and 34.6 g/L in 25 tested patients. There were no unexpected adverse events. In conclusion, IV-Globulin SN was efficacious in adult ITP patients regardless of their disease status as well as safe given that the resolution of bleeding and minimal infusion-related adverse events. (NCT02063789) [Display omitted] Kim:Green Cross Corp.: Employment. Lee:Green Cross Corp.: Employment.