Pharmacy Medical News about Rheumatoid arthritis, Certolizumab pegol, ACR20

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A pharmacodynamic markov mixed-effects model for determining the effect of exposure to certolizumab pegol on the ACR20 score in patients with rheumatoid arthritis
Clinical Pharmacology & Therapeutics, 07/24/09

Lacroix BD et al. – Study presents the development of a mixed-effects Markov model to describe the probability of ACR20 response as a function of certolizumab pegol exposure and disease- and subject-related factors from 5 clinical trials and the application of this model in supporting decision making with respect to the proposed dosing regimen in adults with rheumatoid arthritis (RA).

Methods

Main objectives of this study were to:
- Develop an exposure-response model of ACR20 in subjects receiving treatment with certolizumab pegol, and
- 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 3 defined states

Results

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 wks 0, 2, and 4 followed by 200 mg every 2 wks, or
- An alternative maintenance regimen of 400 mg every 4 wks

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