Treatment of primary immunodeficiency (PI) is typically initiated with intravenous immunoglobulin (IVIG) loading and then continued with IVIG or subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously untreated patients. In the loading phase, SCIG 100 mg/kg was administered for five consecutive days (total loading dose 500 mg/kg). During the maintenance phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy endpoint of IgG levels ≥5 g/L on day 12 was achieved in 17 patients (94.4%; 95% CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. Improvement was found in many subscales of the health-related quality of life questionnaires. SCIG treatment was well tolerated, with no related serious adverse events (AEs). Nine (50%) patients experienced related AEs, including local reactions (rate 0.105 events/infusion). The results suggest that therapy of newly diagnosed patients with PI can be initiated directly with SCIG.
Improvement in Quality of Life Measurements in Newly Diagnosed Patients with Primary Immunodeficiency Receiving Directly Initiated Subcutaneous Replacement Therapy with Vivaglobin / M., Borte; B., Ritchie; A., Plebani; C., Mccusker; E., Fernandez Cruz; D. S., Schmidt; I., Andresen; Quinti, Isabella. - In: JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. - ISSN 0091-6749. - STAMPA. - 125:1(2010), pp. AB140-AB140. (Intervento presentato al convegno 66th Annual Meeting of the American-Academy-of-Allergy-Asthma-and-Immunology tenutosi a New Orleans, LA nel FEB 26-MAR 02, 2010) [10.1016/j.jaci.2009.12.550].
Improvement in Quality of Life Measurements in Newly Diagnosed Patients with Primary Immunodeficiency Receiving Directly Initiated Subcutaneous Replacement Therapy with Vivaglobin
QUINTI, Isabella
2010
Abstract
Treatment of primary immunodeficiency (PI) is typically initiated with intravenous immunoglobulin (IVIG) loading and then continued with IVIG or subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously untreated patients. In the loading phase, SCIG 100 mg/kg was administered for five consecutive days (total loading dose 500 mg/kg). During the maintenance phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy endpoint of IgG levels ≥5 g/L on day 12 was achieved in 17 patients (94.4%; 95% CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. Improvement was found in many subscales of the health-related quality of life questionnaires. SCIG treatment was well tolerated, with no related serious adverse events (AEs). Nine (50%) patients experienced related AEs, including local reactions (rate 0.105 events/infusion). The results suggest that therapy of newly diagnosed patients with PI can be initiated directly with SCIG.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.