Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies - A prospective, multi-national study

Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies - A prospective, multi-national study

Author Gardulf, A. Google Scholar
Nicolay, U. Google Scholar
Asensio, O. Google Scholar
Bernatowska, E. Google Scholar
Bock, A. Google Scholar
Costa-Carvalho, Beatriz Tavares Autor UNIFESP Google Scholar
Granert, C. Google Scholar
Haag, S. Google Scholar
Hernandez, D. Google Scholar
Kiessling, P. Google Scholar
Kus, J. Google Scholar
Pons, J. Google Scholar
Niehues, T. Google Scholar
Schmidt, S. Google Scholar
Schulze, I Google Scholar
Borte, M. Google Scholar
Institution Karolinska Univ Hosp Huddinge
Consorcio Hosp Parc Tauli
Children Mem Hlth Inst
Univ Klin Kinder & Jugendheilkunde
Universidade Federal de São Paulo (UNIFESP)
ZLB Behring GmbH
Hosp Univ La Fe
Natl Res Inst TB & Lung Dis
Hosp Univ Son Dureta
Univ Klinikum Dusseldorf
Med Univ Klin Freiburg
Humboldt Univ
Univ Leipzig
Abstract Sixty patients (16 children, 44 adults) participated in the study aiming at evaluating: (i) IgG levels when switching patients from intravenous IgG (IVIG) infusions in hospital to subcutaneous (SCIG) self-infusions at home using the same cumulative monthly dose, (ii) protections against infections, and (iii) safety of a new, ready-to-use 16% IgG preparation. All children and 33 adults had received IVIG therapy for > 6 months at enrolment. Ten adults who had been on SCIG therapy for many years served as controls. Mean serum IgG trough levels increased in the pre-IVIG children from 7.8 to 9.2 g/L (non-inferiority: p < 0.001) and in the adults from 8.6 to 8.9 g/L (non-inferiority: p < 0.001). Totally 114 respiratory tract infections occurred, 90% of them mild. One serious bacterial infection (pneumonia) was reported for one adult. the annualized rate of serious infections was 0.04 episodes/patient. in total 2297 infusions were given and 28 (1%) systemic adverse reactions occurred, none of them severe. Local tissue reactions declined over time, this being particularly distinct after 8 to 10 weeks. in conclusion, the SCIG administration route was safe. High IgG levels were easily maintained resulting in a very good protection against infections.
Keywords primary antibody deficiency disorders
gammaglobulin treatment
subcutaneous IgG replacement therapy
intravenous IgG replacement therapy
Language English
Date 2006-03-01
Published in Journal of Clinical Immunology. New York: Springer/plenum Publishers, v. 26, n. 2, p. 177-185, 2006.
ISSN 0271-9142 (Sherpa/Romeo, impact factor)
Publisher Springer
Extent 177-185
Origin http://dx.doi.org/10.1007/s10875-006-9002-x
Access rights Closed access
Type Article
Web of Science ID WOS:000238138200009
URI http://repositorio.unifesp.br/handle/11600/28767

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