Date: 2014-11-07
Type of information: Presentation of results at a congress
phase: 2-3
Announcement: presentation of results at the biennial congress of the European Society for Immunodeficiencies , held in Prague
Company: Baxter (USA - IL)
Product: IGSC 20 percent (20 percent concentration subcutaneous immunoglobulin treatment)
Action mechanism:
Disease: primary immunodeficiencies
Therapeutic area: Immunological diseases - Rare diseases
Country:
Trial details:
Latest
news: * On October 30, 2014, Baxter International presented the results of a Phase 2/3 study of its investigational 20 percent concentration subcutaneous immunoglobulin treatment for primary immunodeficiencies (PI) during the biennial congress of the European Society for Immunodeficiencies , held in Prague . Immunoglobulin treatment for patients with primary immunodeficiency typically requires intravenous infusions every three to four weeks or conventional subcutaneous infusions weekly or bi-weekly. The Phase 2/3 study evaluated the efficacy, safety, tolerability and pharmacokinetics 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. There were no serious adverse events (AEs) related to IG treatment. The rate of local AEs considered related to IGSC 20 percent treatment was 0.052/infusion (17 of 48 patients). The majority of local AEs were mild in severity and the most common events were erythema, swelling, pruritus, and pain/discomfort. There were no reports of severe local or systemic AEs related to treatment. Importantly, nearly all infusions (99.8%) were completed without any interruption, slowing, or stopping the infusion. Results from a separate study of IGSC 20 percent among PI patients in North America are expected to be available next year.
