Data presented today suggest that 20 percent liquid formulation, Immune
Globulin Subcutaneous (Human) (SCIg), or IgPro20 effectively protects
patients with primary immunodeficiencies (PI) against infection. The 20
percent formulation, the highest Ig concentration currently available,
was also shown to sustain serum IgG levels without causing unexpected
rates of adverse events. The data were presented at the American Academy
of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans,
US.
“These data suggest that
IgPro20 provides PI patients with robust protection against infections,
while the higher concentration may allow them to infuse the product more
quickly thus potentially enhancing its convenience.”
The data were derived from a study of 49 patients (5-72 years)
previously been treated with intravenous immunoglobulin (IVIG), who
received weekly subcutaneous infusions of L-proline stabilized IgPro20.
The study covered a 15-month period, including a 12-week wash-in/-out
period and a 12-month efficacy period. The primary endpoint of the study
was the annual rate of predefined serious bacterial infections (SBIs)
per patient. No SBIs were reported during the study; 96 non-serious
infections were identified.
Dr. Jordan Orange, Attending Physician, Division of Immunology,
Children’s Hospital of Philadelphia stated: “These data suggest that
IgPro20 provides PI patients with robust protection against infections,
while the higher concentration may allow them to infuse the product more
quickly thus potentially enhancing its convenience.”
The study also showed 99 percent of adverse events (AEs) reported with
IgPro20 to be mild or moderate in intensity. The most common temporally
associated AEs were injection site reactions. No serious IgPro20-related
AEs were reported.