Efficacy and tolerability of Privigen? (IgPro10) in primary and secondary immunodeficiencies - A multicenter observational study

摘要

Introduction: Privigen? (IgPro10) is a 10% polyvalent human IgG preparation for intravenous administration (IVIG) using L-proline as stabiliser. Objective: To investigate the efficacy and tolerability of Privigen? in a large sample of patients with immunodeficiencies. Methods: Interim analysis of an observational study in 119 German centers (cut-off date January 16, 2012). Results: 814 patients (413 males, 401 females; mean age 64 years) received a total of 6156 Privigen? infusions. 140 patients had primary immunodeficiencies (PI), 674 had secondary immunodeficiencies (SI). The average single dose was 15 g, with a mean interval of 30 days. Efficacy was judged as very good or good in 87.5%, moderate in 5.7%, insufficient in 0.6% and not evaluable in 5.8% of the cases (0.5% missing data). Patients who had not received any IVIG treatment for 6 months prior to study entry and who received Privigen? for ≥120 days (≥6 infusions, largest interval ≤60 days) experienced significantly fewer infections during the study than before: In PI the mean annualized infection rate dropped from 7.0 to 2.2 (n=20; p=0.0002), in SI from 5.6 to 1.5 (n=81; p<0.0001). Tolerability was judged as very good or good in 91.2%, moderate in 4.7% and insufficient in 2.9% of all cases (1.1% missing data). Adverse events possibly or probably related to Privigen? were reported for 119 of the 6156 infusions (1.9%); only 4 of them were serious (0.06%). Conclusions: Privigen? (IgPro10) significantly reduced infection rates in PI and SI. Tolerability was very good or good in the majority of patients.