Human Immunoglobulin (KIOVIG ® /GAMMAGARD LIQUID ® ) for Immunodeficiency and Autoimmune Diseases: An Observational Cohort Study
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...
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| Published in | Immunotherapy Vol. 7; no. 7; pp. 753 - 763 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Future Medicine Ltd
01.07.2015
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1750-743X 1750-7448 |
| DOI | 10.2217/imt.15.30 |
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| Abstract | 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. |
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| AbstractList | 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. 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. Aim: To document the therapeutic efficacy and safety of Human Normal Immunoglobulin 10% Liquid (KIOVIG.sup.® /GAMMAGARD LIQUID.sup.® [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. |
| Audience | Academic |
| Author | Blažek, Bohumír Misbah, Siraj A Leibl, Heinz Nikolov, Nikolai Soler-Palacin, Pere McCoy, Barbara Gelmont, David Engl, Werner Empson, Victoria |
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| Cites_doi | 10.1186/s12883-014-0202-3 10.1371/journal.pone.0100324 10.1016/j.molmed.2015.01.005 10.1186/2047-783X-15-6-238 10.1007/s10875-006-9025-3 10.1007/BF03261968 10.1371/journal.pone.0096600 10.1007/s12026-014-8580-6 10.1517/14740338.2010.484419 10.1111/j.1365-2249.2011.04389.x 10.1056/NEJMra1009433 10.1196/annals.1423.054 10.2174/138161211798157540 10.2165/11318980-000000000-00000 10.1016/S0140-6736(78)92644-2 10.1111/j.1423-0410.2011.01476.x 10.5414/CP202204 10.1136/jnnp.2010.206599 10.1016/j.pedneo.2011.11.003 10.1016/j.tmrv.2013.05.004 10.1097/ACI.0000000000000116 10.1038/nri3401 10.5414/CPP43420 10.1007/s00415-008-0979-3 10.1159/000095764 10.2217/imt.14.54 10.1111/cei.12493 10.1007/s10875-014-9995-5 10.1056/NEJMra1114525 10.1016/j.jaip.2013.09.012 10.1182/blood-2009-06-225565 10.2217/imt.12.60 10.3389/fimmu.2014.00626 10.1179/102453310X12719010991867 10.1111/j.1442-200x.2005.02033.x 10.1111/j.1423-0410.2006.00764.x |
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| SubjectTerms | 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 |
| Title | Human Immunoglobulin (KIOVIG ® /GAMMAGARD LIQUID ® ) for Immunodeficiency and Autoimmune Diseases: An Observational Cohort Study |
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