Exposure-safety analyses of nintedanib in patients with chronic fibrosing interstitial lung disease.

ABSTRACT:

Background

Nintedanib reduces the rate of decline in forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype and systemic sclerosis-associated ILD (SSc-ILD). The recommended dose of nintedanib is 150 mg twice daily (BID).

Methods

Data from Phase II and III trials in IPF and Phase III trials in SSc-ILD and progressive fibrosing ILDs other than IPF were analyzed to investigate the relationship between nintedanib plasma concentrations (exposure) and safety (liver enzyme elevations [defined as transaminase elevations equal or greater than 3 times the upper limit of normal] and diarrhea).

Results

Using data from 1403 subjects with IPF treated with 50-150 mg nintedanib

SUBMITTER: Schmid U 

PROVIDER: S-EPMC8293560 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature