This article is part of Pulmonology Advisor’s coverage of the CHEST Virtual 2020 meeting.
Treatment with nintedanib was associated with slowing the rate of forced vital capacity (FVC) decline in patients with progressive fibrosing interstitial lung diseases (ILDs), according to research presented at the 2020 CHEST Annual Meeting, held virtually, October 18 to 21.
The research findings were from the INBUILD trial (ClinicalTrial.gov Identifier: NCT02999178), which included patients from 15 countries who had fibrosing ILD other than idiopathic pulmonary fibrosis (IPF), diffuse fibrosing lung disease of more than 10% extent on high resolution computed tomography (HRCT), FVC of 45% or more predicted, and diffusing capacity of the lungs for carbon monoxide between at least 30% but less than 80% predicted.
All patients had progression of ILD in the 24 months prior to screening despite appropriate clinical management. Progression of ILD was based on worsening symptoms, worsening fibrosis on HRCT, or decline in FVC.
A total of 136 patients in the INBUILD trial from the United States and Canada were randomly assigned to either nintedanib (n=67) or placebo (n=69). Another 527 patients at sites in other countries were also randomly assigned to either nintedanib (n=265) or placebo (n=262). The rate of decline in FVC as well as the incidence of adverse events during the course of 52 weeks were compared between patients from the United States/Canada and patients at sites in other countries.
The mean baseline FVC values in patients from the United States/Canada and other countries were 2319 mL and 2334 mL, respectively. In the United States/Canada group, the adjusted annual rate of FVC decline was -95.5 mL per year with nintedanib and -162.5 mL per year with placebo (difference, 66.9 mL/y; 95% CI, -26.8 to 160.6). Among patients in the other countries, the adjusted annual rate of FVC decline was -77.4 mL per year with nintedanib vs -194.3 mL per year with placebo (difference, 117.0 mL/y; 95% CI, 70.5-163.4).
There was no differential effect of nintedanib vs placebo between patients in the United States/Canada subgroup and the subgroup of patients from other countries in terms of the treatment-by-subgroup-by-time interaction P value (P =.35).
Diarrhea was the most frequently reported adverse event in 74.6% of the patients treated with nintedanib and 42.0% of patients who received placebo from the United States/Canada as well as 64.9% of patients treated with nintedanib and 19.1% of patients who received placebo from other countries. The incidence of adverse events resulted in discontinuation of the study drug in 23.9% and 11.6% of United States/Canada patients in the nintedanib and placebo groups, respectively. In patients from other countries, discontinuation of the study treatment because of adverse events was reported in 18.5% and 9.9% of patients.
The investigators concluded that, based on their findings, treatment with “nintedanib slows ILD progression with adverse events that can be tolerated by most patients.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Shapera S, Moua T, Nambiar A, et al. Efficacy and safety of nintedanib in US/Canadian patients with progressive fibrosing interstitial lung diseases: Further analyses of the INBUILD trial. Presented at: the CHEST Virtual Annual Meeting; October 18-21, 2020. Abstract 2613.