Journal of Clinical Immunology

, Volume 26, Issue 2, pp 177–185

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

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

DOI: 10.1007/s10875-006-9002-x

Cite this article as:
Gardulf, A., Nicolay, U., Asensio, O. et al. J Clin Immunol (2006) 26: 177. doi:10.1007/s10875-006-9002-x

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.

KEY WORDS:

Primary antibody deficiency disordersgammaglobulin treatmentsubcutaneous IgG replacement therapyintravenous IgG replacement therapy

Copyright information

© Springer Science+Business Media, Inc. 2006

Authors and Affiliations

  • Ann Gardulf
    • 1
    • 16
  • Uwe Nicolay
    • 2
  • Oscar Asensio
    • 3
  • Ewa Bernatowska
    • 4
  • Andreas Böck
    • 5
  • Beatriz Costa Carvalho
    • 6
  • Carl Granert
    • 7
  • Stefan Haag
    • 8
  • Dolores Hernández
    • 9
  • Peter Kiessling
    • 8
  • Jan Kus
    • 10
  • Jaune Pons
    • 11
  • Tim Niehues
    • 12
  • Sigune Schmidt
    • 13
  • Ilka Schulze
    • 14
  • Michael Borte
    • 15
  1. 1.Department of Laboratory MedicineSection of Clinical Immunology, The Swedish Centre for Immunodeficiencies, Karolinska Institutet at Karolinska University Hospital HuddingeStockholmSweden
  2. 2.Department of Laboratory MedicineSection of Clinical Immunology, Karolinska Institutet at Karolinska University Hospital HuddingeStockholmSweden
  3. 3.Servicio de Immunologicia ClinicaConsorcio Hospitalari del Parc TauliSabadellSpain
  4. 4.Department of ImmunologyChildren Memorial Health InstituteWarsawPoland
  5. 5.Universitätsklinik für Kinder- und JugendheilkundeViennaAustria
  6. 6.Department of PediatricsDivision of Allergy, Clinical Immunology and RheumatologyFederal University of São PaoloSão PaoloBrazil
  7. 7.Immunodeficiency UnitSection of Clinical Immunology, Karolinska University Hospital HuddingeStockholmSweden
  8. 8.ZLB Behring GmbHMarburgGermany
  9. 9.Department of AllergyHospital Universitario La FeValenciaSpain
  10. 10.National Research Institute of Tuberculosis and Lung DiseasesWarsawPoland
  11. 11.Servicio de ImmunologiaHospital Universitario Son DuretaPalma de MallorcaSpain
  12. 12.Universitätsklinikum DüsseldorfHeinrich-Heine-Universität, Klinik für Kinder-Onkologie, -Hämatologie und -ImmunologieDüsseldorfGermany
  13. 13.Medizinische UniversitätsklinikAbteilung Rheumatologie und Klinische ImmunologieFreiburgGermany
  14. 14.Charité BerlinHumboldt-Universität, Klinik für Pädiatrie mit Schwerpunkt Pneumologie/ImmunologieBerlinGermany
  15. 15.Klinik für Kinder- und Jugendmedizin am Städtischen Klinikum“St. Georg” Leipzig, Akademisches Lehrkrankenhaus der Universität LeipzigLeipzigGermany
  16. 16.Karolinska University Hospital HuddingeStockholmSweden