Effect of Nintedanib in Patients with Progressive Pulmonary Fibrosis in Subgroups with Differing Baseline Characteristics

Abstract

Introduction In the INBUILD trial in patients with progressive pulmonary fibrosis other than idiopathic pulmonary fibrosis (IPF), nintedanib slowed the rate of decline in forced vital capacity (FVC; mL/year) over 52 weeks compared with placebo. We assessed the efficacy of nintedanib across subgroups in the INBUILD trial by baseline characteristics. Methods We assessed the rate of decline in FVC over 52 weeks and time to progression of interstitial lung disease (ILD) (absolute decline from baseline in FVC % predicted > 10%) or death over the whole trial in subgroups based on sex, age, race, body mass index (BMI), time since diagnosis of ILD, FVC % predicted, diffusing capacity of the lungs for carbon monoxide (DLco) % predicted, composite physiologic index (CPI), GAP (gender, age, lung physiology) stage, use of anti-acid therapy and use of disease-modifying antirheumatic drugs (DMARDs) at baseline. Results The effect of nintedanib versus placebo on reducing the rate of decline in FVC over 52 weeks was consistent across the subgroups by baseline characteristics analysed. Interaction p values did not indicate heterogeneity in the treatment effect between these subgroups ( p > 0.05). Over the whole trial (median follow-up time ∼19 months), progression of ILD or death occurred in similar or lower proportions of patients treated with nintedanib than placebo across the subgroups analysed, with no heterogeneity detected between the subgroups. Conclusions In the INBUILD trial, no heterogeneity was detected in the effect of nintedanib on reducing the rate of ILD progression across subgroups based on demographics, ILD severity or use of anti-acid therapy or DMARDs. These data support the use of nintedanib as a treatment for progressive pulmonary fibrosis. Trial Registration Number ClinicalTrials.gov Identifier: NCT02999178. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02668-x.

Predictive factors of progression in fibrosing interstitial lung disease patients with gender-age-physiology stage 0 or I

“…Nintedanib, in particular, was shown to slow the decline in forced vital capacity (FVC) and reduced the incidence of acute exacerbation (AE) in IPF patients in two replicate randomized, double-blind, phase 3 trials (INPULSIS-1 and INPULSIS-2) 7 . Furthermore, a meta-analysis of 12,956 patients with IPF from eight randomized controlled trials and 18 cohort studies revealed that treatment with anti brotic drugs, including nintedanib and pirfenidone, lowered the risk of all-cause mortality and AE 9 . More recently, the INBUILD phase 3 trial reported that nintedanib slowed the decline of FVC over 52 weeks in patients with non-IPF FILD with progressive brosis 10 .…”