PMID- 35356797
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220401
IS  - 2572-9241 (Electronic)
IS  - 2572-9241 (Linking)
VI  - 6
IP  - 4
DP  - 2022 Apr
TI  - Predicting Individual Changes in Terminal Half-Life After Switching to Extended 
      Half-Life Concentrates in Patients With Severe Hemophilia.
PG  - e694
LID - 10.1097/HS9.0000000000000694 [doi]
LID - e694
AB  - 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.
CI  - Copyright (c) 2022 the Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the European Hematology Association.
FAU - Versloot, Olav
AU  - Versloot O
AD  - Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, 
      University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
FAU - Iserman, Emma
AU  - Iserman E
AD  - Department of Health Research Methods, Evidence, and Impact, McMaster University, 
      Hamilton, Ontario, Canada.
FAU - Chelle, Pierre
AU  - Chelle P
AD  - School of Pharmacy, University of Waterloo, Ontario, Canada.
FAU - Germini, Federico
AU  - Germini F
AD  - Department of Health Research Methods, Evidence, and Impact, McMaster University, 
      Hamilton, Ontario, Canada.
AD  - Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
FAU - Edginton, Andrea N
AU  - Edginton AN
AD  - School of Pharmacy, University of Waterloo, Ontario, Canada.
FAU - Schutgens, Roger E G
AU  - Schutgens REG
AD  - Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, 
      University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
FAU - Iorio, Alfonso
AU  - Iorio A
AD  - Department of Health Research Methods, Evidence, and Impact, McMaster University, 
      Hamilton, Ontario, Canada.
FAU - Fischer, Kathelijn
AU  - Fischer K
AD  - Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, 
      University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20220321
PL  - United States
TA  - Hemasphere
JT  - HemaSphere
JID - 101740619
PMC - PMC8939912
EDAT- 2022/04/01 06:00
MHDA- 2022/04/01 06:01
PMCR- 2022/03/21
CRDT- 2022/03/31 05:37
PHST- 2021/09/04 00:00 [received]
PHST- 2022/01/29 00:00 [accepted]
PHST- 2022/03/31 05:37 [entrez]
PHST- 2022/04/01 06:00 [pubmed]
PHST- 2022/04/01 06:01 [medline]
PHST- 2022/03/21 00:00 [pmc-release]
AID - 10.1097/HS9.0000000000000694 [doi]
PST - epublish
SO  - Hemasphere. 2022 Mar 21;6(4):e694. doi: 10.1097/HS9.0000000000000694. eCollection 
      2022 Apr.