Integrated Population Pharmacokinetics of Etanercept in Healthy Subjects and in Patients With Rheumatoid Arthritis Ankylosing Spondylitis
2010; Wiley; Volume: 51; Issue: 6 Linguagem: Inglês
10.1177/0091270010375961
ISSN1552-4604
AutoresSimon Zhou, Cathye Shu, Joan Korth‐Bradley, Donald G. Raible, Maria Palmisano, Joseph Wadjula, Saeed Fatenejad, Thorir D. Bjornsson,
Tópico(s)Spondyloarthritis Studies and Treatments
ResumoThe Journal of Clinical PharmacologyVolume 51, Issue 6 p. 864-875 Integrated Population Pharmacokinetics of Etanercept in Healthy Subjects and in Patients With Rheumatoid Arthritis Ankylosing Spondylitis Dr Simon Y. Zhou PhD, Corresponding Author Dr Simon Y. Zhou PhD Pfizer Specialty Care Business Unit, Clinical Pharmacology, Pfizer Specialty Care Business Unit, Collegeville, PA Address correspondence to: Simon Y. Zhou, 500 Arcola Rd, Collegeville, PA 19426; e-mail: [email protected].Search for more papers by this authorDr Cathye Shu PhD, Dr Cathye Shu PhD Cephalon, Inc, Malvern, PA.Search for more papers by this authorDr Joan Korth-Bradley PhD, Dr Joan Korth-Bradley PhD Pfizer Specialty Care Business Unit, Clinical Pharmacology, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Donald Raible MD, Dr Donald Raible MD Respiratory Disease Clinical Development, Medlmmune, Gaithersburg, MDSearch for more papers by this authorDr Maria Palmisano MD, Dr Maria Palmisano MD Clinical Development Medical Affairs, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Joseph Wadjula PhD, Dr Joseph Wadjula PhD Clinical Development Medical Affairs, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Saeed Fatenejad MD, Dr Saeed Fatenejad MD Clinical Development Medical Affairs, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Thorir Bjornsson MD, Dr Thorir Bjornsson MD Bjornsson Associates, LLC, Saint. Davids, PASearch for more papers by this author Dr Simon Y. Zhou PhD, Corresponding Author Dr Simon Y. Zhou PhD Pfizer Specialty Care Business Unit, Clinical Pharmacology, Pfizer Specialty Care Business Unit, Collegeville, PA Address correspondence to: Simon Y. Zhou, 500 Arcola Rd, Collegeville, PA 19426; e-mail: [email protected].Search for more papers by this authorDr Cathye Shu PhD, Dr Cathye Shu PhD Cephalon, Inc, Malvern, PA.Search for more papers by this authorDr Joan Korth-Bradley PhD, Dr Joan Korth-Bradley PhD Pfizer Specialty Care Business Unit, Clinical Pharmacology, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Donald Raible MD, Dr Donald Raible MD Respiratory Disease Clinical Development, Medlmmune, Gaithersburg, MDSearch for more papers by this authorDr Maria Palmisano MD, Dr Maria Palmisano MD Clinical Development Medical Affairs, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Joseph Wadjula PhD, Dr Joseph Wadjula PhD Clinical Development Medical Affairs, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Saeed Fatenejad MD, Dr Saeed Fatenejad MD Clinical Development Medical Affairs, Pfizer Specialty Care Business Unit, Collegeville, PASearch for more papers by this authorDr Thorir Bjornsson MD, Dr Thorir Bjornsson MD Bjornsson Associates, LLC, Saint. Davids, PASearch for more papers by this author First published: 07 March 2013 https://doi.org/10.1177/0091270010375961Citations: 15Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract Etanercept pharmacokinetics in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriasis were assessed separately with distinct models using population pharmacokinetics methods of limited precision. The different model structures and associated significant covariates identified by these earlier methods made it difficult to compare etanercept pharmacokinetics among disease groups. This integrated analysis aimed to establish a framework to evaluate previously established population pharmacokinetic models of etanercept, and to identify consistent and important demographic and disease factors that affected etanercept pharmacokinetics in a diverse population of healthy subjects and patients with RA and AS. In this integrated analysis, cumulative rich and sparse etanercept concentration data from 53 healthy volunteers, 212 patients with RA, and 346 patients with AS were examined and compared using nonlinear mixed effect methodology implemented the in NONMEM VI software package. A more precise estimation method (FOCEi) was employed and compared with the first-order method in population pharmacokinetics model building and evaluation. The integrated analysis found that an optimal population pharmacokinetics model with a 2-compartment structure adequately characterized etanercept pharmacokinetics in all subject groups. Health status or disease type did not significantly affect etanercept pharmacokinetics. In adult patients with RA and AS, age and body weight do not significantly affect etanercept pharmacokinetics. Citing Literature Volume51, Issue6June 2011Pages 864-875 RelatedInformation
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