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Deprecated: Implicit conversion from float 245.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 CPT+Pharmacometrics+Syst+Pharmacol 2014 ; 3 (10): e143- Nephropedia Template TP
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Simultaneous Exposure?Response Modeling of ACR20, ACR50, and ACR70 Improvement Scores in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol #MMPMID25353186
Lacroix BD; Karlsson MO; Friberg LE
CPT Pharmacometrics Syst Pharmacol 2014[Oct]; 3 (10): e143- PMID25353186show ga
The Markovian approach has been proposed to model American College of Rheumatology's (ACR) response (ACR20, ACR50, or ACR70) reported in rheumatoid arthritis clinical trials to account for the dependency of the scores over time. However, dichotomizing the composite ACR assessment discards much information. Here, we propose a new approach for modeling together the three thresholds: a continuous-time Markov exposure?response model was developed, based on data from five placebo-controlled certolizumab pegol clinical trials. This approach allows adequate prediction of individual ACR20/50/70 time-response, even for non-periodic observations. An exposure?response was established over a large range of licensed and unlicensed doses including phase II dose-ranging data. Simulations from the model (50?400?mg every other week) illustrated the range and sustainability of response (ACR20: 56?68%, ACR50: 27?42%, ACR70: 11?22% at week 24) with maximum clinical effect achieved at the recommended maintenance dose of 200?mg every other week.