Efficacy and safety of nerandomilast in patients with autoimmune disease-related progressive pulmonary fibrosis in the FIBRONEER-ILD trial.
Ann Rheum DisApr 30, 2026 (epub)
Clinical ResearchPulmonology
Anna-Maria Hoffmann-Vold, Shervin Assassi, Vincent Cottin et al.
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In 30 seconds
The FIBRONEER-ILD trial evaluated the efficacy and safety of nerandomilast in 325 patients with autoimmune disease-related progressive pulmonary fibrosis. This randomized controlled trial found that nerandomilast significantly slowed the decline in forced vital capacity (FVC) compared to placebo, with adjusted mean changes at week 52 of -61.2 mL and -64.9 mL for the 9 mg and 18 mg doses, respectively.
Key findings
- Adjusted mean change in FVC at week 52 was -61.2 mL for nerandomilast 9 mg vs -107.1 mL for placebo.
- Hazard ratio for time to first acute exacerbation was 0.66 for nerandomilast 9 mg vs placebo.
- Hazard ratio for time to death was 0.40 for nerandomilast 9 mg vs placebo.
- Adverse events led to treatment discontinuation in 13.0% of placebo and 8.0% of nerandomilast 9 mg groups.
Why it matters
This study highlights the potential of nerandomilast to slow the progression of pulmonary fibrosis in patients with autoimmune ILDs, which may improve patient outcomes and quality of life.