期刊
IMMUNOTHERAPY
卷 11, 期 12, 页码 1057-1065出版社
FUTURE MEDICINE LTD
DOI: 10.2217/imt-2019-0057
关键词
common variable immune deficiency; CUVITRU; immunoglobulin; immunoglobulin replacement therapy (IgRT); Ig20Gly; primary immunodeficiency; safety; subcutaneous; tolerability
类别
资金
- Shire, Takeda group of companies
Aim: This pooled analysis evaluated the safety and tolerability of the subcutaneous immunoglobulin 20% product, Ig20Gly, in primary immunodeficiency diseases using data from two Phase II/III studies conducted in North America and Europe. Patients & materials/methods: Patients received Ig20Gly (volumes, <= 60 ml/site; rates, <= 60 ml/h/site). Adverse events (AEs), tolerability and infusion parameters were assessed. Results: Patients (2-83 years; N = 122) received 6676 Ig20Gly infusions. No causally related serious or severe AEs were reported. Thirty-five patients (28.7%) reported 232 causally related local AEs. Twenty-seven patients (22.1%) reported 165 causally related systemic AEs. There was no association between the infusion volume or rate and causally related local AEs. Conclusion: Ig20Gly was well tolerated in a broad population of patients with primary immunodeficiency diseases.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据