title: Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study.
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.
authors.affiliation: 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
authors.forename: Ann
authors.initials: A
authors.lastname: Gardulf
authors.forename: Uwe
authors.initials: U
authors.lastname: Nicolay
authors.forename: Oscar
authors.initials: O
authors.lastname: Asensio
authors.forename: Ewa
authors.initials: E
authors.lastname: Bernatowska
authors.forename: Andreas
authors.initials: A
authors.lastname: Böck
authors.forename: Beatriz Costa
authors.initials: BC
authors.lastname: Carvalho
authors.forename: Carl
authors.initials: C
authors.lastname: Granert
authors.forename: Stefan
authors.initials: S
authors.lastname: Haag
authors.forename: Dolores
authors.initials: D
authors.lastname: Hernández
authors.forename: Peter
authors.initials: P
authors.lastname: Kiessling
authors.forename: Jan
authors.initials: J
authors.lastname: Kus
authors.forename: Jaune
authors.initials: J
authors.lastname: Pons
authors.forename: Tim
authors.initials: T
authors.lastname: Niehues
authors.forename: Sigune
authors.initials: S
authors.lastname: Schmidt
authors.forename: Ilka
authors.initials: I
authors.lastname: Schulze
authors.forename: Michael
authors.initials: M
authors.lastname: Borte
mesh_terms: 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
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous