The European respiratory journal · 2026
Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Wijsenbeek Marlies S, Assassi Shervin, Azuma Arata, Cottin Vincent, Hoffmann-Vold Anna-Maria, Maher Toby M, Martinez Fernando J, Oldham Justin M, Richeldi Luca, Valenzuela Claudia, Gu Hui, Ritter Ivana, Stowasser Susanne, Kreuter Michael, FIBRONEER-ILD Trial Investigators
Аннотация
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.
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.