Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig® [octanorm]).
Immunotherapy
; 13(10): 813-824, 2021 07.
Article
em En
| MEDLINE
| ID: mdl-33955240
ABSTRACT
Background:
Subcutaneous human immunoglobulin (16.5%; octanorm/cutaquig®) was efficacious and well tolerated in patients with primary immunodeficiencies in a Phase III study. A subanalysis of pediatric data is presented here. Materials &methods:
Children (2-16 years) previously treated with intravenous human immunoglobulin received weekly subcutaneous human immunoglobulin infusions over 64 weeks. The main objective was to assess the efficacy of cutaquig in preventing serious bacterial infections.Results:
38 children received 2213 infusions of cutaquig. No serious bacterial infections developed during the study. The rate of other infections was 3.1 per person-year and the rate of adverse drug reactions was 0.083 per infusion. Higher immunoglobulin G trough levels were achieved with cutaquig compared with previous intravenous therapy.Conclusion:
Once-weekly infusions of cutaquig were efficacious and well tolerated in children with primary immunodeficiencies.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoglobulinas
/
Doenças da Imunodeficiência Primária
Tipo de estudo:
Observational_studies
Limite:
Adolescent
/
Child
/
Child, preschool
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Immunotherapy
Assunto da revista:
ALERGIA E IMUNOLOGIA
/
TERAPEUTICA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Estados Unidos