Baxter International Inc. (BAX) said that it presented the results of a Phase 2/3 study of its investigational 20 percent concentration subcutaneous immunoglobulin treatment for primary immunodeficiencies or PI during the biennial congress of the European Society for Immunodeficiencies, held in Prague.
Immunoglobulin or IG treatment for patients with primary immunodeficiency typically requires intravenous or IV infusions every three to four weeks or conventional subcutaneous or SC infusions weekly or bi-weekly. Conventional subcutaneous IG treatment is associated with fewer systemic adverse events compared with IV, but requires multiple injection sites per infusion given decreased bioavailability and the need for increased volume to achieve efficacy goals.
The Phase 2/3 study evaluated the efficacy, safety, tolerability and pharmacokinetics (PK) of IGSC 20 percent in European patients at least two years old with PI. A total of 48 study participants received IGSC 16 percent or IVIG 10 percent for three months, followed by weekly doses of IGSC 20 percent for up to 12 months (median of two sites per infusion).
The study met its primary endpoint that measured the rate of validated acute serious bacterial infections, or VASBIs. A single event was reported during treatment with IGSC 20 percent (pneumonia of moderate severity), which equated to a low VASBI rate of 0.022/patient-year compared with the specified threshold of one VASBI/patient-year (P<0.0001). The rate of infections with IGSC 20 percent (without dose adjustment) was 4.38/patient-year and mean serum IgG trough levels were comparable to IGIV 10 percent.
Results from a separate study of IGSC 20 percent among PI patients in North America are expected to be available next year.
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