Intravenous immunoglobulin 10% in children with primary immunodeficiency diseases.

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.

• Authors: Hans D Ochs, Isaac Melamed, Michael Borte, James N Moy, Barbara Pyringer, Ai Lan D Kobayashi, Alan P Knutsen, William Smits, Anna Pituch-Noworolska, Roger H Kobayashi
• Journal: Immunotherapy (Immunotherapy) Vol. 10 Issue 14 Pg. 1193-1202 (10 2018) ISSN: 1750-7448 [Electronic] England
• PMID: 30088423 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Immunoglobulin G
• Immunoglobulins, Intravenous
• Panzyga

Topics

• Adolescent
• Adult
• Agammaglobulinemia (epidemiology, therapy)
• Aged
• Bacterial Infections (epidemiology, etiology)
• Child
• Common Variable Immunodeficiency (epidemiology, therapy)
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Follow-Up Studies
• Humans
• Immunoglobulin G (therapeutic use)
• Immunoglobulins, Intravenous (therapeutic use)
• Incidence
• Male
• Middle Aged
• Prospective Studies
• Treatment Outcome
• United States (epidemiology)
• Young Adult