Population Pharmacokinetic and Pharmacokinetic/Pharmacodynamic Modeling of Weight-Based Intravenous Reslizumab Dosing.
Administration, Intravenous
Adolescent
Adult
Aged
Anti-Asthmatic Agents
/ administration & dosage
Antibodies, Monoclonal, Humanized
/ administration & dosage
Asthma
/ drug therapy
Bayes Theorem
Body Weight
Child
Clinical Trials as Topic
Computer Simulation
Dose-Response Relationship, Drug
Drug Administration Schedule
Eosinophils
/ drug effects
Female
Forced Expiratory Volume
/ drug effects
Humans
Male
Middle Aged
Models, Biological
Muscular Diseases
/ chemically induced
Young Adult
exposure
exposure-response eosinophilic asthma
modeling
pharmacodynamic
pharmacokinetic
reslizumab
Journal
Journal of clinical pharmacology
ISSN: 1552-4604
Titre abrégé: J Clin Pharmacol
Pays: England
ID NLM: 0366372
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
04
10
2019
accepted:
25
02
2020
pubmed:
26
4
2020
medline:
10
7
2021
entrez:
26
4
2020
Statut:
ppublish
Résumé
Reslizumab 3.0 mg/kg has demonstrated efficacy in clinical studies of patients with eosinophilic asthma and a history of exacerbations. A population pharmacokinetic (PK) model was developed to determine whether 3.0 mg/kg weight-based dosing is appropriate to obtain consistent reslizumab exposures in all patients. PK data in healthy volunteers and patients ≥12 years with moderate to severe asthma, eosinophilic asthma, or nasal polyposis were analyzed from 4 phase 1, 2 phase 2, and 2 phase 3 studies of intravenous (IV) reslizumab (N = 804). Covariates evaluated included age, race, sex, baseline weight, renal and liver function, concomitant medications, and antidrug antibody status. Exposure-response models were developed to characterize key efficacy (blood eosinophil levels, forced expiratory volume in 1 second [FEV
Substances chimiques
Anti-Asthmatic Agents
0
Antibodies, Monoclonal, Humanized
0
reslizumab
35A26E427H
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1039-1050Informations de copyright
© 2020, The American College of Clinical Pharmacology.
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