Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study.
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.
Gardulf
Ann
A
Department of Laboratory Medicine, Section of Clinical Immunology, The Swedish Centre for Immunodeficiencies, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden. ann.gardulf@ki.se
Nicolay
Uwe
U
Asensio
Oscar
O
Bernatowska
Ewa
E
Böck
Andreas
A
Carvalho
Beatriz Costa
BC
Granert
Carl
C
Haag
Stefan
S
Hernández
Dolores
D
Kiessling
Peter
P
Kus
Jan
J
Pons
Jaune
J
Niehues
Tim
T
Schmidt
Sigune
S
Schulze
Ilka
I
Borte
Michael
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood*; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000276:immunology* / Q000382:microbiology / Q000628:therapy*; D007239:Infections / Q000150:complications / Q000276:immunology; D007279:Injections, Subcutaneous; D008111:Liver Function Tests; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012646:Self Administration; D018582:Sick Leave
D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous