Exposure-response relationship of certolizumab pegol induction and maintenance therapy in patients with Crohn's disease.

ABSTRACT:

Background

Therapeutic drug monitoring may optimize therapy for Crohn's disease (CD).

Aim

To use a population pharmacokinetic model that accounts for the time-varying nature of covariates to simulate certolizumab pegol (CZP) concentrations to evaluate the exposure-response relationship for CZP in Crohn's disease.

Methods

Adults (N = 2157) with Crohn's disease were treated with CZP in nine clinical trials. Simulated CZP concentrations were compared to outcomes at weeks 6 and 26, including Crohn's disease activity index (CDAI) response (decrease from baseline ≥ 100 points), remission (CDAI ≤ 150), C-reactive protein (CRP) ≤ 5 mg/L, faecal calprotectin (FC) ≤ 250 μg/g, and a composite endpoint of CDAI ≤ 150 and FC ≤ 250 μg/g. Multivariable analyses identified covariates

SUBMITTER: Vande Casteele N 

PROVIDER: S-EPMC5765392 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature