التفاصيل البيبلوغرافية
| العنوان: |
Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy |
| المؤلفون: |
Hans-Hartmut Peter, V. Cristea, Volker Wahn, Stephen Jolles, J. de Gracia, Bernd H. Belohradsky, Michael Borte, Bodo Grimbacher, Ewa Bernatowska, O. Zenker, J. Neufang-Hüber |
| المصدر: |
Clinical Immunology. 141(1):90-102 |
| بيانات النشر: |
Elsevier BV, 2011. |
| سنة النشر: |
2011 |
| مصطلحات موضوعية: |
Adult, Male, medicine.medical_specialty, Adolescent, Immunology, Infusions, Subcutaneous, IgPro20, Young Adult, Agammaglobulinemia, Primary immunodeficiency, Hizentra, Subcutaneous IgG, medicine, Humans, Immunology and Allergy, In patient, Prospective Studies, Young adult, Child, Infusions, Intravenous, Prospective cohort study, Adverse effect, Subcutaneous Infusions, business.industry, Immunologic Deficiency Syndromes, Immunoglobulins, Intravenous, Genetic Diseases, X-Linked, Middle Aged, medicine.disease, IgG levels, Surgery, Clinical trial, Common Variable Immunodeficiency, Treatment Outcome, Multicenter study, Child, Preschool, Immunoglobulin G, Anesthesia, Local reactions, Female, business |
| الوصف: |
A prospective, open-label, multicenter, single-arm, Phase III study evaluated the efficacy and safety of Hizentra(®), a 20% human IgG for subcutaneous administration, in 51 primary immunodeficiency patients over 40 weeks. Patients previously on intravenous or subcutaneous IgG were switched to weekly subcutaneous infusions of Hizentra(®) at doses equivalent to their previous treatment. IgG levels achieved with Hizentra(®) were similar to pre-study levels with subcutaneous, and higher by 17.7% than pre-study levels with intravenous IgG. No serious bacterial infections were reported in the efficacy period. The rate of all infections was 5.18/year/patient, the rates of days missed from work/school, and days spent in hospital were 8.00/year/patient and 3.48/year/patient, respectively. Local reactions (rate 0.060/infusion) were mostly mild (87.3%). No serious, Hizentra(®)-related adverse events were reported. Individual median infusion durations ranged between 1.14 and 1.27 h. Hizentra(®) maintained or improved serum IgG levels without dose increases and effectively protected patients against infections. |
| تدمد: |
1521-6616 |
| DOI: |
10.1016/j.clim.2011.06.002 |
| URL الوصول: |
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b0eee2064219df258bb7e17998e8b28 |
| Rights: |
OPEN |
| رقم الانضمام: |
edsair.doi.dedup.....0b0eee2064219df258bb7e17998e8b28 |
| قاعدة البيانات: |
OpenAIRE |