Efficacy, Safety and Tolerability of a New 10% Liquid Intravenous Immune Globulin [IGIV 10%] in Patients with Primary Immunodeficiency

Abstract

The present clinical study was designed to evaluate the efficacy, pharmacokinetics and safety of a new 10% liquid intravenous immune globulin in patients with primary immunodeficiency diseases. Sixty-one adults and children with primary immuno-deficiency diseases received doses of 300-600 mg/kg body weight every 21-28 days for 12 months. No validated acute serious bacterial infections were reported. The 95% confidence interval for the annualized rate of acute serious bacterial infections (primary endpoint) was 0-0.060. A total of four predefined validated other bacterial infections commonly occurring in primary immunodeficiency disease subjects were observed; none were serious, severe or resulted in hospitalization. The median elimination half-life of IgG was 35 days. Median total IgG trough levels varied from 9.6 to 11.2 g/L. Temporally associated adverse experiences were determined for 72 h after each infusion and the most common adverse experience was headache, which was associated with 6.9% of infusions. The study met the primary endpoint for efficacy and demonstrated excellent tolerability of the new 10% liquid intravenous imunoglobulin preparation.

Safety and Efficacy of Privigen®, a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies

“…The study met its primary efficacy endpoint with an annual aSBI rate of 0.08. This rate is comparable to the rates recently observed with other IVIG preparations in patients with PID [19][20][21]. Furthermore, the annual rate of any infection (3.55, including aSBI) reported in this study is consistent with annual infection rates in other published reports [20][21][22].…”

“…However, based on clinical experience, a target serum IgG trough level of at least 5 g/L has been proposed in the literature for IVIG therapy, with even further protection achieved at levels of 9 g/L and higher [24][25][26][27]. Mean serum IgG trough concentrations remained between 8.84 and 10.27 g/L over the course of this study, comparable to trough levels reported in other recent studies [19][20][21][22].…”

“…was higher or in the same range than the infusion rate in studies of other IVIG products [19][20][21][22]. Most patients received infusions at the maximum allowable infusion rate in our study, and yet infusions were very rarely stopped or interrupted because of AEs.…”

Efficacy and Safety of Privigen in Children and Adolescents With Primary Immunodeficiency

“…24 The effi cacy of Privigen as shown in this study (annual rate of aSBI of 0.11 per patient; 99% CI 0.369) was comparable to that of other liquid IVIG preparations tested recently in mixed pediatric and adult patient populations with PID. 18,[27][28][29] Prior studies reporting effi cacy and safety of IVIG products have not reported specifi c rates of aSBI in pediatric patients, nor have declared the proportion of pediatric patients in the study populations. In a study of Flebogamma ® 5% performed in 51 patients aged 14-74 years, the rate of aSBI was 0.061 per patient per year (upper 1-sided 99% CIs of 0.183).…”

“…29 In 61 adults and children (6-72 years) treated with GAMMAGARD LIQUID 10%, no aSBIs occurred during the 12-month period of the study (upper 1-sided 95% CIs of 0.060 per patient per year). 27 In a trial comparing effi cacy of Gamunex ® 10% and Gamimmune ® N, 9 of 73 (12%) patients treated with Gamunex 10% for 9 months experienced aSBIs resulting in a rate of <0.2 per year. 18 This study documents for the fi rst time effi cacy and safety of an IVIG product in pediatric patients with PID.…”