Results
XLA, CVID
PRIMARY IMMUNODEFICIENCY, X-LINKED AGAMMAGLOBULINEMIA, DISEASE, COMMON VARIABLE IMMUNODEFICIENCY, CVID, DISEASE
The analysis included all Gammaplex infusions administered during the PI clinical trials (1482 infusions administered to 123 patients). Of these, 1234 infusions of the 5% IVIG formulation were administered to 108 patients and 248 infusions of the 10% IVIG formulation were administered to 47 patients. Both adult and pediatric patients participated in the 5% and 10% studies. Key patient, disease, and treatment characteristics for each trial are summarized in Patient Demographics, Disease Characteristics, and Infusion Parameters (CVID, common variable immunodeficiency; PI, primary immunodeficiency; XLA, X-linked agammaglobulinemia.*Three adults were premedicated for a total of five infusions of the 5% IVIG formulation and for five infusions of the 10% IVIG formulation. Six pediatric patients were premedicated for a total of 25 infusions of the 10% IVIG formulation. Given the small number of patients and infusions, the effects of premedication were not evaluated in this study.