Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina

Purpose: Several studies have shown that subcutaneous immunoglobulin (SCIG) infusions demonstrate similar efficacy to intravenous Ig (IVIG) in preventing infections in patients with primary immunodeficiency diseases (PID), and are safe and well tolerated in this population. This open, prospective/ r...

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Autores principales:	Bezrodnik, L., Gómez Raccio, A., Belardinelli, G., Regairaz, L., Díaz Ballve, D., Seminario, G., Moreira, I., Riganti, C., Cantisano, C., Díaz, H., Di Giovanni, D.
Formato:	JOUR
Materias:	Argentina Beriglobina P children immunoglobulin therapy intravenous primary immunodeficiency subcutaneous human immunoglobulin adolescent adult article child clinical article clinical trial comparative study controlled study drug efficacy drug safety drug self administration drug tolerability female fever headache human immune deficiency immunoglobulin blood level infection rate infusion related reaction injection site erythema injection site pain injection site pruritus injection site swelling male multicenter study nausea open study preschool child priority journal prospective study retrospective study school child severe combined immunodeficiency X linked agammaglobulinemia Adolescent Child Feasibility Studies Female Humans Immunoglobulin G Immunoglobulins, Intravenous Immunologic Deficiency Syndromes Immunotherapy Infection Injections, Subcutaneous Male Prospective Studies
Acceso en línea:	http://hdl.handle.net/20.500.12110/paper_02719142_v33_n7_p1216_Bezrodnik
Aporte de:	Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) de Universidad de Buenos Aires

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spelling	todo:paper_02719142_v33_n7_p1216_Bezrodnik2023-10-03T15:14:55Z Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina Bezrodnik, L. Gómez Raccio, A. Belardinelli, G. Regairaz, L. Díaz Ballve, D. Seminario, G. Moreira, I. Riganti, C. Cantisano, C. Díaz, H. Di Giovanni, D. Argentina Beriglobina P children immunoglobulin therapy intravenous primary immunodeficiency subcutaneous human immunoglobulin adolescent adult Argentina article child clinical article clinical trial comparative study controlled study drug efficacy drug safety drug self administration drug tolerability female fever headache human immune deficiency immunoglobulin blood level infection rate infusion related reaction injection site erythema injection site pain injection site pruritus injection site swelling male multicenter study nausea open study preschool child priority journal prospective study retrospective study school child severe combined immunodeficiency X linked agammaglobulinemia Adolescent Argentina Child Feasibility Studies Female Humans Immunoglobulin G Immunoglobulins, Intravenous Immunologic Deficiency Syndromes Immunotherapy Infection Injections, Subcutaneous Male Prospective Studies Purpose: Several studies have shown that subcutaneous immunoglobulin (SCIG) infusions demonstrate similar efficacy to intravenous Ig (IVIG) in preventing infections in patients with primary immunodeficiency diseases (PID), and are safe and well tolerated in this population. This open, prospective/ retrospective, multicenter study was designed to compare the effectiveness, safety and tolerability of a 16 % liquid human IgG preparation (Beriglobina P), administered SC, with previous IVIG treatment in PID pediatric patients in Argentina. Methods: Fifteen subjects were enrolled in the study, and a total of 13 subjects (aged 6-18 years) completed the 36-week SCIG treatment period. All children had previously received IVIG treatment. The dose of SCIG equaled the previous IVIG dose and subjects received an average weekly dose of 139 mg/kg (range 105-181) during the SCIG period. Results: Significantly higher serum IgG trough levels were recorded on SCIG treatment at 16, 24, and 36 weeks, when compared with previous IgG trough levels on steady-state IVIG treatment. The annualized infection rate was 1.4 infections/subject/year during the IVIG administration period compared with 0.4 infections/subject/year during the SCIG period. All subjects who completed the study chose to continue administering SCIG at home after the study had ended. Conclusions: These data confirm that self-administered SCIG therapy is a well-tolerated and effective alternative to IVIG therapy for children with PID. © 2013 Springer Science+Business Media New York. JOUR info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/2.5/ar http://hdl.handle.net/20.500.12110/paper_02719142_v33_n7_p1216_Bezrodnik
institution	Universidad de Buenos Aires
institution_str	I-28
repository_str	R-134
collection	Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA)
topic	Argentina Beriglobina P children immunoglobulin therapy intravenous primary immunodeficiency subcutaneous human immunoglobulin adolescent adult Argentina article child clinical article clinical trial comparative study controlled study drug efficacy drug safety drug self administration drug tolerability female fever headache human immune deficiency immunoglobulin blood level infection rate infusion related reaction injection site erythema injection site pain injection site pruritus injection site swelling male multicenter study nausea open study preschool child priority journal prospective study retrospective study school child severe combined immunodeficiency X linked agammaglobulinemia Adolescent Argentina Child Feasibility Studies Female Humans Immunoglobulin G Immunoglobulins, Intravenous Immunologic Deficiency Syndromes Immunotherapy Infection Injections, Subcutaneous Male Prospective Studies
spellingShingle	Argentina Beriglobina P children immunoglobulin therapy intravenous primary immunodeficiency subcutaneous human immunoglobulin adolescent adult Argentina article child clinical article clinical trial comparative study controlled study drug efficacy drug safety drug self administration drug tolerability female fever headache human immune deficiency immunoglobulin blood level infection rate infusion related reaction injection site erythema injection site pain injection site pruritus injection site swelling male multicenter study nausea open study preschool child priority journal prospective study retrospective study school child severe combined immunodeficiency X linked agammaglobulinemia Adolescent Argentina Child Feasibility Studies Female Humans Immunoglobulin G Immunoglobulins, Intravenous Immunologic Deficiency Syndromes Immunotherapy Infection Injections, Subcutaneous Male Prospective Studies Bezrodnik, L. Gómez Raccio, A. Belardinelli, G. Regairaz, L. Díaz Ballve, D. Seminario, G. Moreira, I. Riganti, C. Cantisano, C. Díaz, H. Di Giovanni, D. Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina
topic_facet	Argentina Beriglobina P children immunoglobulin therapy intravenous primary immunodeficiency subcutaneous human immunoglobulin adolescent adult Argentina article child clinical article clinical trial comparative study controlled study drug efficacy drug safety drug self administration drug tolerability female fever headache human immune deficiency immunoglobulin blood level infection rate infusion related reaction injection site erythema injection site pain injection site pruritus injection site swelling male multicenter study nausea open study preschool child priority journal prospective study retrospective study school child severe combined immunodeficiency X linked agammaglobulinemia Adolescent Argentina Child Feasibility Studies Female Humans Immunoglobulin G Immunoglobulins, Intravenous Immunologic Deficiency Syndromes Immunotherapy Infection Injections, Subcutaneous Male Prospective Studies
description	Purpose: Several studies have shown that subcutaneous immunoglobulin (SCIG) infusions demonstrate similar efficacy to intravenous Ig (IVIG) in preventing infections in patients with primary immunodeficiency diseases (PID), and are safe and well tolerated in this population. This open, prospective/ retrospective, multicenter study was designed to compare the effectiveness, safety and tolerability of a 16 % liquid human IgG preparation (Beriglobina P), administered SC, with previous IVIG treatment in PID pediatric patients in Argentina. Methods: Fifteen subjects were enrolled in the study, and a total of 13 subjects (aged 6-18 years) completed the 36-week SCIG treatment period. All children had previously received IVIG treatment. The dose of SCIG equaled the previous IVIG dose and subjects received an average weekly dose of 139 mg/kg (range 105-181) during the SCIG period. Results: Significantly higher serum IgG trough levels were recorded on SCIG treatment at 16, 24, and 36 weeks, when compared with previous IgG trough levels on steady-state IVIG treatment. The annualized infection rate was 1.4 infections/subject/year during the IVIG administration period compared with 0.4 infections/subject/year during the SCIG period. All subjects who completed the study chose to continue administering SCIG at home after the study had ended. Conclusions: These data confirm that self-administered SCIG therapy is a well-tolerated and effective alternative to IVIG therapy for children with PID. © 2013 Springer Science+Business Media New York.
format	JOUR
author	Bezrodnik, L. Gómez Raccio, A. Belardinelli, G. Regairaz, L. Díaz Ballve, D. Seminario, G. Moreira, I. Riganti, C. Cantisano, C. Díaz, H. Di Giovanni, D.
author_facet	Bezrodnik, L. Gómez Raccio, A. Belardinelli, G. Regairaz, L. Díaz Ballve, D. Seminario, G. Moreira, I. Riganti, C. Cantisano, C. Díaz, H. Di Giovanni, D.
author_sort	Bezrodnik, L.
title	Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina
title_short	Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina
title_full	Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina
title_fullStr	Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina
title_full_unstemmed	Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina
title_sort	comparative study of subcutaneous versus intravenous igg replacement therapy in pediatric patients with primary immunodeficiency diseases: a multicenter study in argentina
url	http://hdl.handle.net/20.500.12110/paper_02719142_v33_n7_p1216_Bezrodnik
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Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: A multicenter study in Argentina

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