Infusion parameters of 20% subcutaneous immunoglobulin for primary immunodeficiency diseases among patient support program participants.
Ann Allergy Asthma Immunol
; 127(5): 568-574.e1, 2021 11.
Article
em En
| MEDLINE
| ID: mdl-34224864
ABSTRACT
BACKGROUND:
The safety and efficacy of subcutaneous immune globulin 20% (human) solution (Cuvitru; Ig20Gly) for primary immunodeficiency disease (PID) have been demonstrated in 2 pivotal trials.OBJECTIVE:
To describe patient characteristics and infusion parameters of patients with PID initiating Ig20Gly outside of a clinical trial setting.METHODS:
This retrospective, observational study analyzed records of patients participating in the HelloCuvitru program, a patient support program in the United States providing Ig20Gly free of charge for the first 4 infusions to patients aged 2 years or older who had PID and no previous experience of Ig20Gly. Data were collected retrospectively from patient records and during nurse visits.RESULTS:
A total of 817 patients (88% of 931 enrolled) completed 4 infusions. At the fourth Ig20Gly infusion, the median (interquartile range) dose was 0.55 (0.46-0.69) g/kg/mo, infusion rate per site was 40 (30.0-50.0) mL, and infusion rate per site was 47 (42.5-53.3) mL/h/site. By the fourth infusion, most patients (58%) received Ig20Gly at 2 infusion sites every 7 (30%) or 14 (25%) days. Median prescribed Ig20Gly dose per month was similar across age groups; median infusion volume per site increased with age. Most patients younger than 18 years received infusions every 14 days; patients aged 18 years or older were more likely to receive infusions weekly. Infusion parameters were similar regardless of whether patients received previous immunoglobulin subcutaneously or intravenously.CONCLUSION:
In this large, real-world population of patients with PID, most Ig20Gly infusions were administered for less than 1 hour and required fewer than 2 infusion sites, consistent with the pivotal trials. Infusion rate per site was similar regardless of age, previous immunoglobulin treatment, or infusion frequency.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Imunoglobulinas Intravenosas
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Transferência Adotiva
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Doenças da Imunodeficiência Primária
Tipo de estudo:
Observational_studies
Limite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Ann Allergy Asthma Immunol
Assunto da revista:
ALERGIA E IMUNOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article