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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Detalles Bibliográficos
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
Descripción
Sumario: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.

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