Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases.
Immunotherapy
; 14(4): 215-224, 2022 03.
Article
en En
| MEDLINE
| ID: mdl-34931880
ABSTRACT
Aim:
This post hoc analysis evaluated the efficacy and overall tolerability of immunoglobulin (Ig) treatment modalities (intravenous Ig [iv.Ig], subcutaneous Ig [sc.Ig] and facilitated sc.Ig [fsc.Ig]). Materials &methods:
A total of 30 participants with primary immunodeficiency diseases aged ≥2 years sequentially received iv.Ig, sc.Ig and fsc.Ig during consecutive clinical studies.Results:
For iv.Ig, sc.Ig and fsc.Ig, rates of validated acute serious bacterial infections/participant-year (0, 0.09 and 0.04, respectively) and all infections/participant year (4.17, 3.68 and 2.42, respectively) were similarly low; rates of systemic and local causally related adverse events/participant-year were 5.60, 1.93 and 0.88, respectively and 0.13, 0.92 and 1.57, respectively.Conclusion:
fsc.Ig provided similar efficacy to iv.Ig and sc.Ig. Clinical Trial registration NCT00546871, NCT00814320, NCT01175213 (ClinicalTrials.gov).Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Infecciones Bacterianas
/
Inmunoglobulinas
/
Inmunización Pasiva
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Enfermedades de Inmunodeficiencia Primaria
Tipo de estudio:
Observational_studies
/
Risk_factors_studies
Límite:
Adolescent
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Child
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Child, preschool
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Immunotherapy
Asunto de la revista:
ALERGIA E IMUNOLOGIA
/
TERAPEUTICA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Estados Unidos