Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial - PubMed
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- #nerandomilast
- #clinical trial
- Nerandomilast 9 mg and 18 mg bid reduced decline in forced vital capacity at week 52 vs placebo in FIBRONEER-ILD trial.
- Key secondary endpoint: hazard ratio for acute exacerbation, hospitalization, or death was 0.78 for 9 mg and 0.77 for 18 mg bid compared to placebo.
- Hazard ratios were lower in patients not taking background nintedanib (0.69 for 9 mg, 0.65 for 18 mg) vs those on nintedanib (0.90 for 9 mg, 0.93 for 18 mg).
- Hazard ratio for death vs placebo was 0.51 for both nerandomilast doses.
- Discontinuation due to adverse events was similar across groups: 12.5% placebo, 12.0% nerandomilast 9 mg, 12.3% nerandomilast 18 mg.
- Mean exposure to trial medication was 15.1 months with mean observation period of 17.0 months.
- Nerandomilast showed favourable safety and tolerability profile over the whole trial period.