CLINICAL ASSESSMENT OF PHARMACOKINETICS AND SAFETY OF NOVEL GLYCINE STABILIZED 10% IVIG IN PIDD PATIENTS

Abstract

<h3>Introduction</h3> This study aimed to evaluate the safety and pharmacokinetics (PK) of a novel glycine stabilized 10% immunoglobulin preparation for intravenous (IV) administration in patients with primary immunodeficiency disease (PIDD). <h3>Methods</h3> Phase III, open-label, prospective, multi-center study. The primary endpoint of the study was the incidence rate of acute serious bacterial infections (ASBIs) per patient-year. Forty-seven patients across 11 US sites received 200 to 800 mg/kg IVIg every 21 or 28 days for 48 weeks. The experimental IVIg had an average of 6 μg/ml IgA content. Additional end points included IgG trough levels, all infections other than ASBIs, hospitalization for any reason, and incidence of drug-related adverse events. <h3>Results</h3> No patients in the study had an ASBI. IgG trough levels were maintained well above the level of 600 mg/dL throughout the study in all patients except for one. The incidence rate of any infection other than ASBI was 2.0. Four patients were hospitalized during the study not attributed to an infection or the study drug. Twenty-two patients (46.8%) reported 75 drug-related AEs. The most frequently reported (≥ 5%) drug-related AEs were headache in 12 patients (25.5%), infusion-related reaction in 5 patients (10.6%), nausea, fatigue and Coombs direct test positive in 4 patients (8.5%) each. There were no cases of thrombosis. No AEs led to study discontinuation and no patients died during the study due to AE. <h3>Conclusion</h3> The novel glycine stabilized 10% IVIg is highly efficacious for treatment of PIDD with no serious infections, low overall infections, and no adverse event related study discontinuation.