title: Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141).
abstract: OBJECTIVE
  A multi-centre, non-comparative study examining the efficacy and safety of Subgam, a normal immunoglobulin (IgG) given weekly as a rapid subcutaneous infusion to patients with primary immune deficiency (PID), is reported. Also included is a summary of adverse drug reactions associated with the use of marketed Subgam in the UK.
  
  
  METHODS
  50 patients with stable PID on IgG therapy were enrolled: Stage 1 included three infusions with prior IgG product followed by 6 months with Subgam, Stage 2 involved long-term Subgam therapy up to 4 years.
  
  
  RESULTS
  Stage 1, 85% of the subjects aged >12 years and 93% of the subjects aged <12 years achieved IgG levels ≥6 and ≥4 g/L, respectively at all observations. There were 3.62 infections/patient/year during Subgam treatment. The most common product-related events were infusion site reactions (50% of patients). Recent post-hoc pharmacokinetics analysis of the post-infusion serum total IgG concentration indicated that the mean dose-normalised incremental IgG AUCτ following intravenous dosing (120.5 g.day/L) was 1.64-fold that of the dose-normalised mean incremental IgG AUCτ following subcutaneous dosing (73.6 g.day/L), corresponding to an estimated IgG bioavailability for subcutaneous dosing of 61%. Only 34 post-licensing adverse reactions have been received in 30 patients over a period of 10 years; fourteen were classed as serious as defined by the ICH guidelines on good clinical practice. The most common post-licensing adverse reaction was infusion site reaction (7 reports). There were 7 reports of flu-like symptoms (pyrexia/shivering/rigors/feeling hot or cold), 2 other reports of combined flu-like symptoms and infusion site reactions, 5 reports of generalised skin reactions, and 3 reports of combined infusion site and skin reactions. There were also reports of anaphylaxis (2 reports) and 8 other adverse events (including headache). In conclusion, Subgam is effective and well tolerated in the treatment of PID.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02247141.
authors.affiliation: CD Consultants, St Albans, United Kingdom.
authors.forename: Clive
authors.initials: C
authors.lastname: Dash
authors.affiliation: Medical Department, Bio Products Laboratory Limited (BPL), Elstree, Hertfordshire (Herts.), United Kingdom.
authors.forename: Ernie
authors.initials: E
authors.lastname: Gascoigne
authors.affiliation: Medical Department, Bio Products Laboratory Limited (BPL), Elstree, Hertfordshire (Herts.), United Kingdom.
authors.forename: Kate
authors.initials: K
authors.lastname: Gillanders
authors.affiliation: Department of Clinical Immunology and Allergy, King's College Hospital, London, United Kingdom.
authors.forename: Hock
authors.initials: H
authors.lastname: Gooi
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D007153:Immunologic Deficiency Syndromes / Q000097:blood* / Q000188:drug therapy*; D055104:Infusions, Subcutaneous; D008297:Male
chemical_list: D016756:Immunoglobulins, Intravenous