Human Immunoglobulin (KIOVIG ® /GAMMAGARD LIQUID ® ) for Immunodeficiency and Autoimmune Diseases: An Observational Cohort Study

• Published in: Immunotherapy Vol. 7; no. 7; pp. 753 - 763
• Main Authors: Blažek, Bohumír, Misbah, Siraj A, Soler-Palacin, Pere, McCoy, Barbara, Leibl, Heinz, Engl, Werner, Empson, Victoria, Gelmont, David, Nikolov, Nikolai
• Format: Journal Article
• Language: English
• Published: England Future Medicine Ltd 01.07.2015
• Subjects: Adolescent; Adult; Aged; Autoimmune diseases; Autoimmune Diseases - drug therapy; Autoimmune Diseases - immunology; Care and treatment; Child; Child, Preschool; Female; Health aspects; Humans; Immunoglobulins; Immunoglobulins, Intravenous - administration & dosage; Immunoglobulins, Intravenous - adverse effects; Immunologic Deficiency Syndromes - drug therapy; Infant; Kawasaki disease; Male; Middle Aged; Pharmacological research; Precision medicine; Research funding; Stock options; Studies; Surveillance; immunodeficiency; GAMMAGARD LIQUID; autoimmune disease; intravenous immunoglobulin; KIOVIG
• ISSN: 1750-743X; 1750-7448
• DOI: 10.2217/imt.15.30

To document the therapeutic efficacy and safety of Human Normal Immunoglobulin 10% Liquid (KIOVIG(®)/GAMMAGARD LIQUID(®) [IVIG 10%]) under clinical routine conditions. 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. 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. In this observational study, the efficacy and safety of IVIG 10% in routine clinical practice was similar to that previously reported in clinical studies.