Human immunoglobulin (KIOVIG®/GAMMAGARD LIQUID®) for immunodeficiency and autoimmune diseases: an observational cohort study

Immunotherapy. 2015;7(7):753-63. doi: 10.2217/imt.15.30. Epub 2015 Apr 13.

Abstract

Aim: To document the therapeutic efficacy and safety of Human Normal Immunoglobulin 10% Liquid (KIOVIG(®)/GAMMAGARD LIQUID(®) [IVIG 10%]) under clinical routine conditions.

Patients & methods: Subjects received IVIG 10% according to the prescribing information and were followed for 6 ± 1 weeks to 12 ± 2 months depending on indication. Efficacy, adverse events, infusion rates and duration and dose were recorded.

Results: Overall efficacy of IVIG 10% was rated as good or very good by the investigator in 81.8% of subjects; overall tolerability was good or very good in 87.5%. One serious adverse drug reaction (ADR) occurred (urticaria); no severe ADRs occurred.

Conclusion: In this observational study, the efficacy and safety of IVIG 10% in routine clinical practice was similar to that previously reported in clinical studies.

Keywords: GAMMAGARD LIQUID; KIOVIG; autoimmune disease; immunodeficiency; intravenous immunoglobulin.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Autoimmune Diseases / drug therapy*
  • Autoimmune Diseases / immunology
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Immunoglobulins, Intravenous / administration & dosage*
  • Immunoglobulins, Intravenous / adverse effects
  • Immunologic Deficiency Syndromes / drug therapy*
  • Infant
  • Male
  • Middle Aged

Substances

  • Immunoglobulins, Intravenous