Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials.

ABSTRACT:

Aims

In this exposure-response analysis, the dosing regimen for tildrakizumab, an antibody for treating moderate-to-severe chronic plaque psoriasis, was determined using data from 3 randomised controlled trials (P05495/NCT01225731: phase 2b, n = 355; reSURFACE 1/NCT01722331: phase 3, n = 772; reSURFACE 2/NCT01729754: phase 3, n = 1090).

Methods

A maximum drug effect (E_max ) logistic-regression exposure-efficacy model was used to describe the week 12 Psoriasis Area and Severity Index (PASI) responses with average concentration of tildrakizumab during weeks 1-12 (C_avg12 ) as exposure metric. The impact of covariates (e.g., body weight, region) was tested. Exposure-safety, longitudinal pharmacokinetic-pharmacodynamic and risk-benefit analyses were also con

SUBMITTER: Kerbusch T 

PROVIDER: S-EPMC7444761 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature