A Population Pharmacokinetic and Exposure-Response Analysis for Baricitinib in Pediatric Patients with Atopic Dermatitis.

ABSTRACT:

Background

Baricitinib is approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy and has received regulatory authorization in Europe for moderate-to-severe AD in patients 2 to <18 years.

Objective

This study aims to optimize dosing for baricitinib in pediatric patients with atopic dermatitis using pharmacokinetic/pharmacodynamic modeling leveraging adult data.

Methods

The phase III, randomized, double-blind, placebo-controlled study, BREEZE-AD-PEDS (NCT03952559, registration date: 2019-05-16), enrolled patients (aged 2 to <18 years) with moderate-to-severe AD. During a pharmacokinetic (PK) lead-in period, baricitinib concentration data from age-based dose cohorts (4 mg once daily [QD]: 10 to <18 year

SUBMITTER: Decker RL 

PROVIDER: S-EPMC12783266 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature