ISSN: 2155-9899
Ruth Dana
Tanzania
Research Article
Observational Study of Intravenous Immunoglobulin 5% for Alleviating Adverse Drug Reactions in Primary Immunodeficiency Disorders
Author(s): Isaac Melamed, Melinda Heffron, Ruth Dana, Alessandro Testori and Nazia RashidIsaac Melamed, Melinda Heffron, Ruth Dana, Alessandro Testori and Nazia Rashid
Background: Intravenous immunoglobulin (IVIG) preparations are used to treat individuals with primary immunodeficiency disorders (PIDD) by increasing low immunoglobulin levels. This observational study was designed to assess the change in adverse drug reactions (ADRs) in subjects switching from IVIG 10% to IVIG 5% and explore potential underlying mechanisms.
Methods: The primary endpoint was the change in ADRs between IVIG 10% (various products) and IVIG 5% (Octagam 5%) as assessed by a severity rating scale (1=none, 2=mild, 3=moderate, 4=severe). The recruitment goal was 15 subjects receiving IVIG 10% who had experienced ADRs up to 72 hours post-infusion. Subjects were then switched to IVIG 5% at the next scheduled infusion and continued on this regimen for a total of 6 infusions. Secondary endpoints included changes in C1 esterase inhibitor .. View More»