title: Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy.
abstract: 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.
authors: Division of Immunology, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA. orange@mail.med.upenn.edu
authors: J S
authors: JS
authors: Orange
authors: B H
authors: BH
authors: Belohradsky
authors: M
authors: M
authors: Berger
authors: M
authors: M
authors: Borte
authors: J
authors: J
authors: Hagan
authors: S
authors: S
authors: Jolles
authors: R L
authors: RL
authors: Wasserman
authors: J S
authors: JS
authors: Baggish
authors: R
authors: R
authors: Saunders
authors: B
authors: B
authors: Grimbacher
mesh_terms: D001424:Bacterial Infections / Q000209:etiology; D006801:Humans; D007116:Immunization, Passive / Q000009:adverse effects; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000097:blood; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000628:therapy*; D055104:Infusions, Subcutaneous; D016896:Treatment Outcome
chemical_list: D007074:Immunoglobulin G