A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn's Disease.

ABSTRACT:

Background

Certolizumab pegol (CZP) is effective for moderately to severely active Crohn's disease (CD). Higher plasma concentrations are associated with better outcomes and increased drug clearance is the driver of subtherapeutic CZP concentrations.

Objective

We aimed to develop a prediction model incorporating predicted CZP clearance and patient variables to allow estimation of the probability for remission prior to initiating therapy.

Methods

A population pharmacokinetic model estimated baseline CZP clearance in patients with CD from nine phase II and III trials. Multivariable prediction models were developed and validated using the PRECiSE 1 and PRECiSE 2 datasets to identify candidate predictors for a composite remission outcome (Crohn's Disease Activity Index ≤ 

SUBMITTER: Lefevre PLC 

PROVIDER: S-EPMC9826742 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature