Hans D Ochs1, Isaac Melamed2, Michael Borte3, James N Moy4, Barbara Pyringer5, Ai Lan D Kobayashi6, Alan P Knutsen7, William Smits8, Anna Pituch-Noworolska9, Roger H Kobayashi10. 1. Department of Pediatrics, University of Washington & Seattle Children's Research Institute, 1900 Ninth Avenue, Seattle, WA 98101, USA. 2. IMMUNOe Research Centers, 6801 South Yosemite Street, Centennial, CO 80112, USA. 3. Klinik für Kinder- und Jugendmedizin, Klinikum St. Georg gGmbH, Delitzscher Str. 141, 04129 Leipzig, Germany. 4. Division of Pediatric Allergy/Immunology, Stroger Hospital of Cook County, 1901 W. Harrison Street, Chicago, IL 60612, USA. 5. Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaer Str. 235, 1100 Vienna, Austria. 6. Midlands Pediatrics PC, 401 E. Gold Coast Road, Suite 325, Papillion, NE 68046, USA. 7. Cardinal Glennon Children's Hospital, Saint Louis University, 1 N Grand Blvd, St Louis, MO 63103, USA. 8. The Allergy & Asthma Center, 7222 Engle Rd, Fort Wayne, IN 46804, USA. 9. Department of Pediatrics, University Children Hospital, Jagiellonian University, Wielicka st 265, 30-663 Kraków, Poland. 10. Division of Pediatric Allergy and Immunology, Department of Pediatrics, UCLA School of Medicine, Los Angeles, CA 90095, USA.
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.
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: Casey Lee McAtee; Joseph Lubega; Kristen Underbrink; Kristen Curry; Pavlos Msaouel; Martha Barrow; Eyal Muscal; Timothy Lotze; Poyyapakkam Srivaths; Lisa R Forbes; Carl Allen; M Brooke Bernhardt Journal: JAMA Netw Open Date: 2021-02-01
Authors: Natalia Riva; Manuel Molina; Berta L Cornaló; María V Salvador; Andrea Savransky; Silvia Tenembaum; María M Katsicas; Marta Monteverde; Paulo Cáceres Guido; Marcela Rousseau; Raquel Staciuk; Agustín González Correas; Pedro Zubizarreta; Oscar Imventarza; Eduardo Lagomarsino; Eduardo Spitzer; Marcelo Tinelli; Paula Schaiquevich Journal: Front Pharmacol Date: 2022-01-26 Impact factor: 5.810