Intravenous immunoglobulin 10% in children with primary immunodeficiency diseases. (17th October 2018)

• Record Type: Journal Article
• Authors: Ochs, Hans D; Melamed, Isaac; Borte, Michael; Moy, James N; Pyringer, Barbara; D Kobayashi, Ai Lan; Knutsen, Alan P; Smits, William; Pituch-Noworolska, Anna; Kobayashi, Roger H
• Is Part Of: Immunotherapy. Volume 10:Number 14(2018)
• Page Start: 1193
• Page End: 1202
• Publication Date: 2018-10-17
• Subjects: children -- intravenous immunoglobulin -- Panzyga® -- pediatric patients -- primary antibody deficiency; Immunotherapy -- Periodicals; 615.37
• DOI: 10.2217/imt-2018-0074
• Languages: English
• ISSNs: 1750-743X

Abstract

Aim: To assess the safety and efficacy of an intravenous immunoglobulin (IVIG) 10% preparation (Panzyga ® ; Octapharma AG, Lachen, Switzerland) in predominantly antibody-deficient children with primary immunodeficiency disease.Methods: Data from two prospective, open-label and noncontrolled multicenter Phase III studies of IVIG 10% that included 25 patients <16 years of age were analyzed for efficacy, pharmacokinetics and safety.Results: The rate of serious bacterial infections was 0.04/patient-year. A maximal infusion rate of 0.14 ml/kg/min was achieved in 82% of pediatric patients (n = 9). Infusions of immunoglobulin G trough levels between infusions remained ≥5–6 g/l; median half-life was 32.79−36.62 days. Abdominal pain, headache and chills were the most common treatment-related adverse events.Conclusion: IVIG 10% is safe and effective for the treatment of predominantly antibody-deficient children.