Evidence- and consensus-based recommendations for the use of pegvaliase in adults with phenylketonuria.
PALYNZIQ, pegvaliase
anaphylaxis management
dietary management
hypophenylalaninemia
Journal
Genetics in medicine : official journal of the American College of Medical Genetics
ISSN: 1530-0366
Titre abrégé: Genet Med
Pays: United States
ID NLM: 9815831
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
14
08
2018
accepted:
29
11
2018
pubmed:
14
12
2018
medline:
7
2
2020
entrez:
15
12
2018
Statut:
ppublish
Résumé
Phenylketonuria (PKU) is a rare metabolic disorder that requires life-long management to reduce phenylalanine (Phe) concentrations within the recommended range. The availability of pegvaliase (PALYNZIQ™, an enzyme that can metabolize Phe) as a new therapy necessitates the provision of guidance for its use. A Steering Committee comprising 17 health-care professionals with experience in using pegvaliase through the clinical development program drafted guidance statements during a series of face-to-face meetings. A modified Delphi methodology was used to demonstrate consensus among a wider group of health-care professionals with experience in using pegvaliase. Guidance statements were developed for four categories: (1) treatment goals and considerations prior to initiating therapy, (2) dosing considerations, (3) considerations for dietary management, and (4) best approaches to optimize medical management. A total of 34 guidance statements were included in the modified Delphi voting and consensus was reached on all after two rounds of voting. Here we describe evidence- and consensus-based recommendations for the use of pegvaliase in adults with PKU. The manuscript was evaluated against the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument and is intended for use by health-care professionals who will prescribe pegvaliase and those who will treat patients receiving pegvaliase.
Identifiants
pubmed: 30546086
doi: 10.1038/s41436-018-0403-z
pii: S1098-3600(21)01611-7
pmc: PMC6752676
doi:
Substances chimiques
Recombinant Proteins
0
Phenylalanine
47E5O17Y3R
Phenylalanine Ammonia-Lyase
EC 4.3.1.24
pegvaliase
N6UAH27EUV
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1851-1867Subventions
Organisme : NINDS NIH HHS
ID : R01 NS080866
Pays : United States
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