Predicting Individual Changes in Terminal Half-Life After Switching to Extended Half-Life Concentrates in Patients With Severe Hemophilia.


Journal

HemaSphere
ISSN: 2572-9241
Titre abrégé: Hemasphere
Pays: United States
ID NLM: 101740619

Informations de publication

Date de publication:
Apr 2022
Historique:
received: 04 09 2021
accepted: 29 01 2022
entrez: 31 3 2022
pubmed: 1 4 2022
medline: 1 4 2022
Statut: epublish

Résumé

Predicting individual effects of switching from standard half-life (SHL) to extended half-life (EHL) FVIII/FIX concentrates is pivotal in clinical care, but large-scale individual data are scarce. The aim of this study was to assess individual changes in terminal half-life (THL) after switching to EHL concentrates and identifying determinants of a clinically relevant THL extension in people with severe hemophilia. Data from participants with pharmacokinetic studies on both SHL and EHL were extracted from the Web-Accessible Population Pharmacokinetics Service (WAPPS) database and stratified according to hemophilia type and age groups (children/adults). A 30% increase in THL was considered clinically relevant. Predictors of a relevant increase were identified using logistic regression. Data from 688 persons with severe hemophilia (2174 infusions) were included: 89% hemophilia A; median age: 21.7 (interquartile range [IQR]: 11.5-37.7); positive inhibitor history: 11.7%. THL increased by 38% (IQR: 17%-67%) and 212% (139%-367%) for hemophilia A and B, respectively. All EHL-FIX concentrate users showed clinically relevant THL extension. However, 40% (242/612) of people with hemophilia A showed limited extension or decrease in THL after switching. Relevant FVIII-THL extension was predicted by short baseline THL and blood group non-O in both children and adults. In conclusion, clinically relevant THL extension was observed in all 75/76 participants switching to EHL-FIX, and in 60% of 612 switching to EHL-FVIII. Short THL on SHL-FVIII and blood group non-O were identified as predictors for a relevant THL increase after switching to EHL-FVIII. Individualized pharmacokinetic assessment may guide clinical decision-making when switching from SHL to EHL-FVIII.

Identifiants

pubmed: 35356797
doi: 10.1097/HS9.0000000000000694
pmc: PMC8939912
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e694

Informations de copyright

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association.

Références

Haemophilia. 2020 Aug;26 Suppl 6:1-158
pubmed: 32744769
Qual Life Res. 2018 May;27(5):1335-1345
pubmed: 29392598
Haemophilia. 2018 May;24(3):376-384
pubmed: 29732708
Blood. 2012 Sep 20;120(12):2405-11
pubmed: 22859609
Lancet Haematol. 2017 Feb;4(2):e75-e82
pubmed: 28159192
Semin Thromb Hemost. 2016 Feb;42(1):18-29
pubmed: 26771678
Haemophilia. 2011 Jan;17(1):2-10
pubmed: 20731726
Haemophilia. 2019 May;25(3):408-415
pubmed: 31050134
Thromb Res. 2020 Dec;196:550-558
pubmed: 33157394
Haemophilia. 2010 Jul 1;16(4):597-605
pubmed: 20148977
J Vet Pharmacol Ther. 2004 Dec;27(6):427-39
pubmed: 15601438
Int J Pediatr Obes. 2010 Dec;5(6):458-60
pubmed: 20233144
Blood. 2012 Mar 29;119(13):3031-7
pubmed: 22223821
PLoS One. 2009 Aug 25;4(8):e6745
pubmed: 19707594
J Thromb Haemost. 2015 Jun;13(6):967-77
pubmed: 25912075
Haemophilia. 2015 May;21(3):300-6
pubmed: 25643824
J Thromb Haemost. 2014 Nov;12(11):1935-9
pubmed: 25059285
Haemophilia. 2020 May;26(3):384-400
pubmed: 32281726
J Pharmacokinet Pharmacodyn. 2019 Oct;46(5):411-426
pubmed: 31104228
N Engl J Med. 2013 Dec 12;369(24):2313-23
pubmed: 24304002
J Thromb Haemost. 2018 Jul;16(7):1437-1441
pubmed: 29762905
Thromb Haemost. 2000 Jan;83(1):65-9
pubmed: 10669157
Transfus Med Hemother. 2018 Apr;45(2):86-91
pubmed: 29765290
JMIR Res Protoc. 2016 Dec 07;5(4):e232
pubmed: 27927609
Blood. 2011 Sep 8;118(10):2695-701
pubmed: 21555744
Implement Sci. 2013 Dec 01;8:139
pubmed: 24289295
J Thromb Haemost. 2021 Aug;19(8):1896-1906
pubmed: 34013558
Haemophilia. 2001 Jul;7(4):392-6
pubmed: 11442644
J Clin Med. 2017 Mar 28;6(4):
pubmed: 28350322
TH Open. 2020 Nov 08;4(4):e362-e364
pubmed: 33178904
JMIR Res Protoc. 2016 Dec 15;5(4):e239
pubmed: 27977390
Toxicol Pathol. 1995 Mar-Apr;23(2):115-23
pubmed: 7569664
Expert Opin Drug Metab Toxicol. 2016 Nov;12(11):1313-1321
pubmed: 27539370
Thromb J. 2016 Oct 4;14(Suppl 1):32
pubmed: 27766058
Haemophilia. 2017 May;23(3):408-416
pubmed: 28233383
Blood. 2014 Jan 16;123(3):317-25
pubmed: 24227821
Haemophilia. 2018 May;24(3):348-358
pubmed: 29633467
J Thromb Haemost. 2016 Apr;14(4):724-32
pubmed: 26806557
Educ Psychol Meas. 2019 Oct;79(5):874-882
pubmed: 31488917

Auteurs

Olav Versloot (O)

Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Emma Iserman (E)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Pierre Chelle (P)

School of Pharmacy, University of Waterloo, Ontario, Canada.

Federico Germini (F)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Andrea N Edginton (AN)

School of Pharmacy, University of Waterloo, Ontario, Canada.

Roger E G Schutgens (REG)

Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Alfonso Iorio (A)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Kathelijn Fischer (K)

Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Classifications MeSH