BibTex format
@article{Wijsenbeek:2026:10.1183/13993003.01899-2025,
author = {Wijsenbeek, MS and Assassi, S and Azuma, A and Cottin, V and Hoffmann-Vold, A-M and Maher, TM and Martinez, FJ and Oldham, JM and Richeldi, L and Valenzuela, C and Gu, H and Ritter, I and Stowasser, S and Kreuter, M and FIBRONEER-ILD, Trial Investigators},
doi = {10.1183/13993003.01899-2025},
journal = {Eur Respir J},
title = {Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial.},
url = {http://dx.doi.org/10.1183/13993003.01899-2025},
volume = {68},
year = {2026}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - BACKGROUND: In the FIBRONEER-ILD trial in patients with progressive pulmonary fibrosis (PPF), nerandomilast 9mg twice daily and 18mg twice daily (hereafter nerandomilast 9mg and 18mg, respectively) reduced the decline in forced vital capacity at week 52 compared with placebo (primary end-point). We assessed the effects of nerandomilast up to the final database lock. METHODS: Time to first acute exacerbation of interstitial lung disease, hospitalisation for respiratory cause or death (key secondary end-point) and other time-to-event end-points were assessed. RESULTS: 1176 patients, of whom 512 were taking background nintedanib, received nerandomilast or placebo. At the final database lock, the mean±sd exposure to trial medication was 15.1±5.7months and the mean±sd observation period was 17.0±4.1months. Compared with placebo, the hazard ratio for the key secondary end-point was 0.78 (95% CI 0.61-1.00) for nerandomilast 9mg and 0.77 (95% CI 0.60-0.99) for nerandomilast 18mg; hazard ratios were lower among patients not taking nintedanib (0.69 (95% CI 0.49-0.97) and 0.65 (95% CI 0.46-0.92), respectively) than among those taking background nintedanib (0.90 (95% CI 0.63-1.30) and 0.93 (95% CI 0.65-1.34), respectively). For death, the hazard ratio versus placebo was 0.51 (95% CI 0.34-0.78) for both nerandomilast doses. Adverse events led to discontinuation of trial medication in 12.5%, 12.0% and 12.3% of the placebo, nerandomilast 9mg and nerandomilast 18mg groups, respectively. CONCLUSIONS: In the FIBRONEER-ILD trial in patients with PPF, nerandomilast reduced the risk of clinically important outcomes, including death, over the whole trial. Nerandomilast had a favourable safety and tolerability profile.
AU - Wijsenbeek,MS
AU - Assassi,S
AU - Azuma,A
AU - Cottin,V
AU - Hoffmann-Vold,A-M
AU - Maher,TM
AU - Martinez,FJ
AU - Oldham,JM
AU - Richeldi,L
AU - Valenzuela,C
AU - Gu,H
AU - Ritter,I
AU - Stowasser,S
AU - Kreuter,M
AU - FIBRONEER-ILD,Trial Investigators
DO - 10.1183/13993003.01899-2025
PY - 2026///
TI - Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial.
T2 - Eur Respir J
UR - http://dx.doi.org/10.1183/13993003.01899-2025
UR - https://www.ncbi.nlm.nih.gov/pubmed/41887669
VL - 68
ER -