Efficacy, safety, and tolerability of Kedrion 10% IVIG in primary immunodeficiency
| Autor: | Gordon Sussman, John Hooper, William R. Lumry, Robert D. Pesek, Roberta Macchia, Santhosh Kumar, Ralph Shapiro, Garrett E. Bergman, James N. Moy, Vladislava Zamfirova, Mark R. Stein, Donald L. McNeil, Hartwig Gajek, Julia Upton, Chaim M. Roifman, Agnes Nemet |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Antibody deficiency medicine.medical_specialty biology business.industry medicine.disease Hypogammaglobulinemia 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Pharmacokinetics Tolerability Blood product hemic and lymphatic diseases Internal medicine Immunology Primary immunodeficiency medicine biology.protein Antibody business Antibody formation 030215 immunology |
| Zdroj: | LymphoSign Journal. 3:99-109 |
| ISSN: | 2292-5945 2292-5937 |
| DOI: | 10.14785/lymphosign-2016-0004 |
| Popis: | Background: Primary immunodeficiency involving defective antibody formation requires antibody replacement therapy with immunoglobulin products to prevent and reduce infections. Immunoglobulin for intravenous use (IVIG) is a processed blood product with limited availability, and the various marketed IVIG products may have different tolerability among patients. New IVIG products are therefore necessary to offer options to patients and to reduce the risk of a product shortage. Methods: Forty-five adult and pediatric patients with primary immunodeficiency, documented agammaglobulinemia or hypogammaglobulinemia, and antibody deficiency were enrolled in a prospective, multi-centre, open-label, single-arm historically controlled Phase III study to evaluate the safety, efficacy, and pharmacokinetics of a new 10% IVIG produced by Kedrion. Results: Forty-four patients completed the study while one withdrew consent. Over the 12-month study period, only 2 episodes of acute serious bacterial infections (both bacterial pneumonias) were recorded, for a mean annual event rate of 0.04 per subject, with an upper one-sided 99% confidence limit of 0.11. Values for all secondary efficacy endpoints were comparable with those in similar studies. The primary safety endpoint was met as the rate of infusions temporally associated (i.e., within 72 hours) with ≥1 adverse event was 16% (upper 95% confidence limit 20.4%). Pharmacokinetics were assessed in 31 patients and found to be comparable with those published for other IVIG products. Conclusion: Kedrion IVIG 10% is safe, efficacious, and well tolerated by patients with primary immunodeficiency. Statement of novelty: This report describes the safety, efficacy, and pharmacokinetics of a new IVIG preparation. |
| Databáze: | OpenAIRE |
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