Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency.

PubWeight™: 0.75‹?›

🔗 View Article (PMID 27220317)

Published in J Clin Immunol on May 25, 2016

Authors

Richard L Wasserman1, Isaac Melamed2, Mark R Stein3, Werner Engl4, Marlies Sharkhawy4, Heinz Leibl4, Jennifer Puck5, Arye Rubinstein6, Lisa Kobrynski7, Sudhir Gupta8, Andrew J Grant9, Anoshie Ratnayake10, Wendell G Richmond11, Joseph Church12, Leman Yel13, David Gelmont14

Author Affiliations

1: Allergy Partners of North Texas Research, Dallas, TX, USA.
2: IMMUNOe Clinical Research Center, Centennial, CO, USA.
3: Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA.
4: Baxalta Innovations GmbH, Vienna, Austria.
5: University of California San Francisco, San Francisco, CA, USA.
6: Allergy & Immunology Division, Montefiore Medical Center, Bronx, NY, USA.
7: Emory Children's Center, Emory University, Atlanta, GA, USA.
8: University of California, Irvine, CA, USA.
9: University of Texas Medical Branch, Galveston, TX, USA.
10: West Coast Clinical Trials, Cypress, CA, USA.
11: Allergy and Asthma Physicians, Hinsdale, IL, USA.
12: Children's Hospital Los Angeles, Los Angeles, CA, USA.
13: Baxalta US Inc., Cambridge, MA, USA.
14: Baxalta US Inc., Westlake Village, CA, 91362-3811, USA. david.gelmont@baxalta.com.

Associated clinical trials:

Gammagard Liquid and rHuPH20 in PID | NCT00814320

Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID | NCT01175213

Articles cited by this

Primary immunodeficiency diseases: an update on the classification from the international union of immunological societies expert committee for primary immunodeficiency. Front Immunol (2011) 3.05

Primary immunodeficiency diseases: an update from the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. J Allergy Clin Immunol (2007) 2.98

Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. Clin Immunol (2010) 2.93

Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol (2004) 2.65

Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol (2006) 2.22

Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study. J Clin Immunol (2011) 1.78

Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv (2007) 1.72

Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet (1991) 1.72

Health-related quality of life and treatment satisfaction in North American patients with primary immunedeficiency diseases receiving subcutaneous IgG self-infusions at home. J Clin Immunol (2006) 1.71

Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol (2010) 1.66

Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol (2004) 1.60

Improved quality of life, immunoglobulin G levels, and infection rates in patients with primary immunodeficiency diseases during self-treatment with subcutaneous immunoglobulin G. South Med J (2010) 1.59

Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol (2008) 1.41

Subcutaneous administration of IgG. Immunol Allergy Clin North Am (2008) 1.31

Efficacy and safety of hizentra®, a new 20% immunoglobulin preparation for subcutaneous administration, in pediatric patients with primary immunodeficiency. J Clin Immunol (2011) 1.28

Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol (2012) 1.18

Safety and efficacy of subcutaneous human immunoglobulin in children with primary immunodeficiency. Acta Paediatr (2007) 1.14

Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAMMAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease. J Clin Immunol (2011) 1.12

Quality of life and health-care resource utilization among children with primary immunodeficiency receiving home treatment with subcutaneous human immunoglobulin. J Clin Immunol (2008) 1.11

Subcutaneous immunoglobulin: opportunities and outlook. Clin Exp Immunol (2009) 1.09

Assessment and implication of the allergic sensitivity to a single dose of recombinant human hyaluronidase injection: a double-blind, placebo-controlled clinical trial. J Infus Nurs (2007) 0.99

Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol (2007) 0.97

Efficacy and safety of a new immunoglobulin G product, Gammaplex(®), in primary immunodeficiency diseases. Clin Exp Immunol (2010) 0.96

Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med (2007) 0.95

Safety of rapid subcutaneous gammaglobulin infusions in patients with primary antibody deficiency. Immunodeficiency (1993) 0.93

Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin (2010) 0.92

Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease. Clin Immunol (2013) 0.92

Efficacy and safety of home-based subcutaneous immunoglobulin replacement therapy in paediatric patients with primary immunodeficiencies. Clin Exp Immunol (2011) 0.90

Progress in gammaglobulin therapy for immunodeficiency: from subcutaneous to intravenous infusions and back again. J Clin Immunol (2012) 0.88

Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics (2009) 0.82

Subcutaneous immunoglobulin (16 or 20%) therapy in obese patients with primary immunodeficiency: a retrospective analysis of administration by infusion pump or subcutaneous rapid push. Clin Exp Immunol (2013) 0.80

Subcutaneous immunoglobulin infusion to treat infants and toddlers with antibody deficiencies. Ann Allergy Asthma Immunol (2010) 0.77

Clinical Immunogenicity of rHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration. AAPS J (2015) 0.77