Population Pharmacokinetics of Sarilumab in Patients with Rheumatoid Arthritis.

ABSTRACT:

Background and objective

Sarilumab binds to the interleukin-6 receptor with high affinity, inhibiting cis and trans signaling by interleukin-6. Sarilumab has demonstrated efficacy and safety in patients with rheumatoid arthritis. The objective of this study was to develop a population-pharmacokinetic model using data from 1770 patients with rheumatoid arthritis across phase I-III studies.

Methods

Potential covariates were identified using a stepwise forward-addition and backward-deletion strategy, and the final model was evaluated by visual predictive check and bootstrap methods.

Results

Sarilumab pharmacokinetics is described by a two-compartment model with first-order absorption and parallel linear and nonlinear Michaelis-Menten elimination. A subcutaneous dose of s

SUBMITTER: Xu C 

PROVIDER: S-EPMC6856490 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature