Population Pharmacokinetics and Exposure-Response Model-Based Bayesian Extrapolation of FVC-Based Efficacy Endpoints From Adults to Pediatric Patients Receiving Nintedanib.

ABSTRACT: Nintedanib reduces the rate of decline in forced vital capacity (FVC) in adult patients with idiopathic pulmonary fibrosis (IPF), chronic progressive-fibrosing interstitial lung diseases (ILDs) and systemic sclerosis-associated ILD (SSc-ILD). A pediatric Phase 3 trial (InPedILD) has been conducted in children 6-17 years, and partial extrapolation from adults to pediatrics was performed to support dose selection and benefit-risk assessment in pediatric patients with progressive-fibrosing ILDs. Previously developed population pharmacokinetic (popPK) and efficacy exposure-response (ER) meta-models across all non-oncologic pulmonary indications of nintedanib in adults were used as a basis for partial extrapolation to pediatric patients. Data from InPedILD and its open-label extension trial (In

SUBMITTER: Hartmann S 

PROVIDER: S-EPMC12823301 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature