Journal of Clinical Immunology

, Volume 26, Issue 3, pp 265–273

Safety and Efficacy of Self-Administered Subcutaneous Immunoglobulin in Patients with Primary Immunodeficiency Diseases

Authors

    • Department of PediatricsUniversity of Washington School of Medicine
    • Department of PediatricsUniversity of Washington School of Medicine
  • Sudhir Gupta
    • Department of MedicineUniversity of California, Division of Basic & Clinical Immunology
  • Peter Kiessling
    • ZLB Behring
  • Uwe Nicolay
    • Karolinska Institutet
  • Melvin Berger
    • Rainbow Babies and Children's HospitalDivision of Allergy, Immunology and Rheumatology
  • the Subcutaneous IgG Study Group
Article

DOI: 10.1007/s10875-006-9021-7

Cite this article as:
Ochs, H.D., Gupta, S., Kiessling, P. et al. J Clin Immunol (2006) 26: 265. doi:10.1007/s10875-006-9021-7

Intravenous immunoglobulin (IVIg) infusions at 3–4 week intervals are currently standard therapy in the United States for patients with primary immune deficiency diseases (PIDD). To evaluate alternative modes of immunoglobulin administration we have designed an open-label study to investigate the efficacy and safety of a subcutaneously administered immunoglobulin preparation (16% IgG) in patients with PIDD. After their final IVIg infusion, 65 patients entered a 3-month, wash-in/wash-out phase, designed to bring patients to steady-state with subcutaneously administered immunoglobulin. This was followed by 12 months of weekly SCIg infusions, at a dose determined in a pharmacokinetic substudy to provide noninferior intravascular exposure. This resulted in a mean weekly dose of 158 mg/kg, calculated to equal 137% of the previous intravenous dose. Two patients (4%) each reported 1 serious bacterial infection (pneumonia), an annual rate of 0.04 per patient-year. There were 4.43 infections of any type per patient-year. Mean trough serum IgG levels increased from 786 to 1040 mg/dL during the study, a mean increase of 39%. The most frequent treatment-related adverse event was infusion-site reaction, reported by 91% of patients; this was predominantly mild or moderate, and the incidence decreased over time. No treatment-related serious adverse events were reported. We conclude that subcutaneous administration of 16% SCIg is a safe and effective alternative to IVIg for replacement therapy of PIDD.

KEY WORDS:

Primary immune deficiency diseasesimmunoglobulin therapysubcutaneousintravenoussafety and efficacy

Abbreviations used:

AEs

adverse events

CL

confidence limit

HIV

human immunodeficiency virus

ITT

intention-to-treat

IgA

immunoglobulin A

IgG

immunoglobulin G

PIDD

primary immune deficiency diseases

IVIg

intravenously administered immunoglobulin

SCIg

subcutaneously administered immunoglobulin

SBIs

serious bacterial infections.

Copyright information

© Springer Science+Business Media, Inc. 2006