Rapid Subcutaneous IgG Replacement Therapy is Effective and Safe in Children and Adults with Primary Immunodeficiencies—A Prospective, Multi-National Study

Authors: Gardulf, Ann; Nicolay, Uwe; Asensio, Oscar; Bernatowska, Ewa; Böck, Andreas; Carvalho, Beatriz; Granert, Carl; Haag, Stefan; Hernández, Dolores; Kiessling, Peter; Kus, Jan; Pons, Jaune; Niehues, Tim; Schmidt, Sigune; Schulze, Ilka; Borte, Michael

Source: Journal of Clinical Immunology, Volume 26, Number 2, March 2006 , pp. 177-185(9)

Publisher: Springer

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

Document Type: Research article

DOI: http://dx.doi.org/10.1007/s10875-006-9002-x

Affiliations: 1: Email: ann.gardulf@ki.se

Publication date: 2006-03-01

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• In this Subject: Microbiology ,  Allergy & Immunology
• By this author: Gardulf, Ann ;  Nicolay, Uwe ;  Asensio, Oscar ;  Bernatowska, Ewa ;  Böck, Andreas ;  Carvalho, Beatriz ;  Granert, Carl ;  Haag, Stefan ;  Hernández, Dolores ;  Kiessling, Peter ;  Kus, Jan ;  Pons, Jaune ;  Niehues, Tim ;  Schmidt, Sigune ;  Schulze, Ilka ;  Borte, Michael

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