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

Overview

Journal J Clin Immunol

Publisher Springer

Specialty Allergy & Immunology

Date 2006 Jun 8

PMID 16758340

Citations 76

Authors

Ann Gardulf

Uwe Nicolay

Oscar Asensio

Ewa Bernatowska

Andreas Bock

Beatriz Costa Carvalho

Carl Granert

Stefan Haag

Dolores Hernandez

Peter Kiessling

Jan Kus

Jaune Pons

Tim Niehues

Sigune Schmidt

Ilka Schulze

Michael Borte

Affiliations

Soon will be listed here.

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.

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