Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy

J. S. Orange, B. H. Belohradsky, M. Berger, M. Borte, J. Hagan, S. Jolles, R. L. Wasserman, J. S. Baggish, R. Saunders, B. Grimbacher

Research output: Contribution to journalArticlepeer-review

78 Scopus citations


The importance of serum immunoglobulin (Ig)G concentration in IgG replacement therapy for primary immunodeficiency diseases is established in certain settings. Generally, IgG is infused via the intravenous (IVIG) or subcutaneous (SCIG) route. For IVIG infusion, published data demonstrate that higher IgG doses and trough levels provide patients with improved protection from infection. The same conclusions are not yet accepted for SCIG; data from two recent Phase III studies and a recent post-hoc analysis, however, suggest the same correlation between higher SCIG dose and serum IgG concentration and decreased incidence of infection seen with IVIG. Other measures of clinical efficacy have not been considered similarly. Thus, combined analyses of these and other published SCIG studies were performed; a full comparison of the 13 studies was, however, limited by non-standardized definitions and reporting. Despite these limitations, our analyses indicate that certain clinical outcomes improve at higher SCIG doses and associated higher serum IgG concentrations, and suggest that there might be opportunity to improve patient outcomes via SCIG dose adjustment.

Original languageEnglish (US)
Pages (from-to)172-181
Number of pages10
JournalClinical and Experimental Immunology
Issue number2
StatePublished - Aug 2012


  • Dose
  • IgG replacement therapy
  • Immunoglobulin
  • Primary immunodeficiency
  • Subcutaneous

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology


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