A Multicentric Clinical Study to Evaluate Pharmacokinetics, Efficacy, and Safety of Immune Globulin Subcutaneous 20% Weekly/Biweekly Dosing in Treatment-Experienced Patients and Loading/Weekly Maintenance Dosing in Treatment-Naive Patients with Primary Immunodeficiency.

ABSTRACT: Intravenous immunoglobulin (IVIG) therapy is a well-documented and effective treatment for primary immunodeficiencies (PI). Subcutaneous immunoglobulins (SCIG) have emerged as an effective alternative for some patients that offers additional flexibility.Currently, caprylate/chromatography purified IGSC (human) 20% is approved to treat PI in North America and many countries worldwide. In this multi-center, open-label study, the pharmacokinetics (PK), efficacy, and safety of IGSC 20% were studied after biweekly (every two weeks) dosing for 16 weeks and compared to weekly IGSC 20% administration for 16 weeks in treatment-experienced PI patients. A loading/weekly maintenance SC regimen was also studied in PI patients naïve to IG treatment.In treatment-experienced patients, the least squares me

SUBMITTER: Lumry WR 

PROVIDER: S-EPMC12605441 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature