Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2009-9-18
pubmed:abstractText
The American College of Rheumatology (ACR) 20% preliminary definition of improvement in rheumatoid arthritis (RA) (ACR20) is widely used in clinical trials to assess response to treatment. The objectives of this analysis were to develop an exposure-response model of ACR20 in subjects receiving treatment with certolizumab pegol and to predict clinical outcomes following various treatment schedules. At each visit, subjects were classified as being ACR20 responders or ACR20 nonresponders or as having dropped out. A Markov mixed-effects model was developed to investigate the effects of the drug on the transitions between the three defined states. Increasing certolizumab pegol exposure predicted an increasing probability of becoming a responder and remaining a responder, as well as a reduced probability of dropping out of treatment. Data from simulations of the ACR20 response rate support the use of dosing regimens of 400 mg at weeks 0, 2, and 4 followed by 200 mg every 2 weeks, or an alternative maintenance regimen of 400 mg every 4 weeks.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
1532-6535
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
86
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
387-95
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:19626001-Adolescent, pubmed-meshheading:19626001-Adult, pubmed-meshheading:19626001-Age Factors, pubmed-meshheading:19626001-Aged, 80 and over, pubmed-meshheading:19626001-Antibodies, Monoclonal, Humanized, pubmed-meshheading:19626001-Antirheumatic Agents, pubmed-meshheading:19626001-Arthritis, Rheumatoid, pubmed-meshheading:19626001-Female, pubmed-meshheading:19626001-Health Status Indicators, pubmed-meshheading:19626001-Humans, pubmed-meshheading:19626001-Immunoglobulin Fab Fragments, pubmed-meshheading:19626001-Male, pubmed-meshheading:19626001-Markov Chains, pubmed-meshheading:19626001-Middle Aged, pubmed-meshheading:19626001-Patient Dropouts, pubmed-meshheading:19626001-Polyethylene Glycols, pubmed-meshheading:19626001-Randomized Controlled Trials as Topic, pubmed-meshheading:19626001-Sex Factors, pubmed-meshheading:19626001-Young Adult
pubmed:year
2009
pubmed:articleTitle
A pharmacodynamic Markov mixed-effects model for determining the effect of exposure to certolizumab pegol on the ACR20 score in patients with rheumatoid arthritis.
pubmed:affiliation
Pharmacometrics, Department of Global Exploratory Development, UCB Pharma SA, Braine-l'Alleud, Belgium. brigitte.lacroix@ucb.com
pubmed:publicationType
Journal Article