Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial
Year: 2026
Type: article
Abstract: Background In the FIBRONEER-ILD trial in patients with progressive pulmonary fibrosis (PPF), nerandomilast 9 mg twice daily and 18 mg twice daily (hereafter nerandomilast 9 mg and 18 mg, 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±5.7 months and the mean± sd observation period was 17.0±4.1 months. Compared with placebo, the hazard ratio for the key secondary end-point was 0.78 (95% CI 0.61–1.00) for nerandomilast 9 mg and 0.77 (95% CI 0.60–0.99) for nerandomilast 18 mg; 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 9 mg and nerandomilast 18 mg 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.
Source: European Respiratory Journal
Authors: Marlies S. Wijsenbeek, Shervin Assassi, Arata Azuma, Vincent Cottin, Anna-Maria Hoffmann-Vold, Toby M. Maher, Fernando J. Martinez, Justin M. Oldham, Luca Richeldi, Claudia Valenzuela, Hui Gu, Ivana Ritter, Susanne Stowasser, Michael Kreuter, on behalf of the FIBRONEER-ILD Trial Investigators
Institutions: Erasmus MC, The University of Texas Health Science Center at Houston, Nippon Medical School, Lyon 1 Université, Hospices Civils de Lyon, Hôpital Louis Pradel, Oslo University Hospital, University of Zurich, University Hospital Zurich, University of Southern California, Imperial College London, University of Massachusetts Chan Medical School, University of Michigan, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, Boehringer Ingelheim (United States), Boehringer Ingelheim (Germany), University Medical Center of the Johannes Gutenberg University Mainz
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funders: Boehringer Ingelheim, Amgen, Bristol-Myers Squibb, Pfizer, AstraZeneca, GlaxoSmithKline, Biogen, F. Hoffmann-La Roche, United Therapeutics Corporation, CSL Behring, Galecto, Veracyte, Galápagos, Ministero della Salute, Ipsen, National Institutes of Health, Genentech, National Heart, Lung, and Blood Institute
OpenAlex ID: W7140815262