Subcutaneous immunoglobulin 20%: Phase II/III data

An open-label, European Phase II/III trial in 48 patients ages >=2 with primary immunodeficiencies showed that subcutaneous immunoglobulin 20% met the primary endpoint of a VASBI rate lower than the specified threshold of 1 VASBI/patient-year. Specifically, there was 1 VASBI event of pneumonia, for a VASBI rate of 0.022/patient-year (p<0.0001 compared to the specified threshold). The rate of infections with subcutaneous immunoglobulin 20% was 4.38/patient-year. There were no serious adverse events related to immunoglobulin treatment reported, and the most common adverse events reported were erythema, swelling, pruritus and pain/discomfort. Patients received subcutaneous immunoglobulin 16% or IV immunoglobulin 10% for 3 months, followed by once-weekly subcutaneous immunoglobulin 20% for up to 12 months. Data were presented at the European Society for Immunodeficiencies meeting in Prague. Data from a North American Phase II/III trial of subcutaneous immunoglobulin 20% in patients with primary immunodeficiencies are expected next year. ...