Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial.

Summary

Across 1176 patients with progressive pulmonary fibrosis, nerandomilast reduced the composite risk of first acute exacerbation, respiratory hospitalization, or death over a mean 17-month observation. Benefits were more pronounced without background nintedanib, and tolerability was favorable.

Key Findings

• Nerandomilast reduced the composite of first AE-ILD, respiratory hospitalization, or death (HR 0.78 for 9 mg bid; HR 0.77 for 18 mg bid vs placebo).
• Greater benefit was observed in patients not on background nintedanib (HR 0.69 and 0.65 for 9 mg and 18 mg, respectively).
• Safety and tolerability were favorable over a mean 17.0-month observation.

Clinical Implications

Nerandomilast could be considered as a disease-modifying therapy in PPF, especially in patients not receiving background nintedanib. Clinicians should monitor for event reduction across AE-ILD and respiratory hospitalizations while assessing long-term safety.

Limitations

• This report reflects whole follow-up analyses; detailed mortality HRs were incomplete in the abstract.
• Subgroup estimates by background antifibrotic therapy were exploratory and not powered for definitive interaction testing.

Future Directions

Head-to-head and add-on trials versus established antifibrotics, longer-term safety surveillance, and biomarker-defined enrichment could refine positioning and patient selection.