Pharmacokinetic Analysis of Weekly Versus Biweekly IgPro20 Dosing in Patients With Primary Immunodeficiency.
IgPro20
pharmacokinetic
primary immunodeficiency
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
02
08
2019
accepted:
14
10
2019
pubmed:
10
12
2019
medline:
13
8
2021
entrez:
10
12
2019
Statut:
ppublish
Résumé
Flexible dosing of IgPro20 (Hizentra®, CSL Behring, King of Prussia, Pennsylvania) maintains normal serum immunoglobulin G (IgG) levels in patients with primary immunodeficiencies (PID). Until now, clinical trials testing the pharmacokinetic (PK) characteristics of serum IgG of weekly and biweekly subcutaneous IgG therapy were not published. This is the first study assessing PK characteristics following weekly and biweekly IgPro20 in patients with PID. The PK study was conducted in 2 parts: weekly dosing (12 weeks) and biweekly dosing (up to 12 months). Serum IgG concentration-time data were analyzed using noncompartmental methods to generate PK parameters. Fifteen patients provided PK samples for both dosing regimens. For weekly and biweekly regimens, mean doses per infusion were 109 and 213 mg/kg, respectively, and median t
Identifiants
pubmed: 31814328
doi: 10.1002/cpdd.753
pmc: PMC7586812
doi:
Substances chimiques
Hizentra
0
Immunoglobulin G
0
Types de publication
Clinical Trial, Phase IV
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
664-670Informations de copyright
© 2019, The American College of Clinical Pharmacology.
Références
J Clin Immunol. 2014 Aug;34(6):611-4
pubmed: 24888599
Clin Pharmacokinet. 2011 Jun;50(6):405-14
pubmed: 21553933
Clin Exp Immunol. 2009 Dec;158 Suppl 1:51-9
pubmed: 19883424
J Clin Immunol. 2018 Jan;38(1):129-143
pubmed: 29226301
J Allergy Clin Immunol. 2004 Oct;114(4):936-42
pubmed: 15480339
Clin Exp Immunol. 2011 Jun;164(3):357-64
pubmed: 21413943
Postgrad Med. 2013 Nov;125(6):53-61
pubmed: 24200761
BioDrugs. 2007;21(2):105-16
pubmed: 17402794
Int Immunopharmacol. 2019 Jun;71:404-410
pubmed: 30952104
J Clin Immunol. 2006 May;26(3):265-73
pubmed: 16783465
Clin Case Rep Rev. 2015 Jul 28;1(7):151-152
pubmed: 27042340
Clin Exp Immunol. 2007 Sep;149(3):410-23
pubmed: 17565605
Immunotargets Ther. 2013 Sep 18;2:125-33
pubmed: 27471693
J Clin Immunol. 2015 Nov;35(8):696-726
pubmed: 26482257
J Clin Immunol. 2018 Nov;38(8):864-875
pubmed: 30415311
Clin Exp Immunol. 2015 Feb;179(2):146-60
pubmed: 25384609
J Clin Immunol. 2012 Aug;32(4):663-9
pubmed: 22392046
Clin Exp Immunol. 2008 May;152(2):274-9
pubmed: 18341618
Biol Ther. 2014 Dec;4(1-2):41-55
pubmed: 25118975
J Clin Immunol. 2018 Jul;38(5):602-609
pubmed: 29951948
J Clin Immunol. 2018 Nov;38(8):886-897
pubmed: 30465179
Clin Exp Immunol. 2015 Sep;181(3):441-50
pubmed: 25761372
J Clin Immunol. 2000 Mar;20(2):94-100
pubmed: 10821460
Clin Immunol. 2011 Oct;141(1):90-102
pubmed: 21705277
J Clin Immunol. 2010 Sep;30(5):734-45
pubmed: 20454851
Immunol Allergy Clin North Am. 2008 May;28(2):413-37, x
pubmed: 18424340
Adv Ther. 2011 Jul;28(7):521-33
pubmed: 21681653
Int Rev Immunol. 2012 Dec;31(6):451-61
pubmed: 23215767