Real-world results with IgPro20 for hypo- or agammaglobulinemia in Japan.

ABSTRACT:

Background

Subcutaneous immunoglobulin is one of the standard treatments for hypogammaglobulinemia in primary immunodeficiencies (PID) worldwide. In Japan, IgPro20 (Hizentra^® ; l-proline-stabilized 20% human subcutaneous immunoglobulin) is approved for agammaglobulinemia or hypogammaglobulinemia due to PID or secondary immunodeficiency (SID); however, its safety and effectiveness has not previously been assessed in a real-world setting.

Methods

This multicenter, open label post-marketing surveillance study was conducted between January 2014 and March 2019. Patients who received IgPro20 due to PID or SID were included after informed consent. Physicians completed a case report form for each patient. Safety was determined from reported adverse events (AEs), adverse d

SUBMITTER: Imai K 

PROVIDER: S-EPMC10099597 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature