Nerandomilast in autoimmune lung fibrosis: FVC change not significant, events favoured

Design

Subgroup analysis of a phase 3 randomised placebo-controlled trial

Population

325 patients with autoimmune disease–related progressive pulmonary fibrosis

Primary outcome

Change in FVC at week 52

Effect

18 mg vs placebo +42.2 mL (95% CI −24.9 to 109.3); death HR 0.28 (0.11–0.69)

FIBRONEER-ILD randomised patients with progressive pulmonary fibrosis to nerandomilast 9 mg or 18 mg twice daily or placebo. This analysis, published in April, examined the 325 participants whose fibrosis was related to autoimmune disease.

At 52 weeks, FVC fell by about 107 mL with placebo, 61 mL with 9 mg and 65 mL with 18 mg; the differences (about 46 and 42 mL) were not statistically significant in this subgroup, with intervals crossing zero. Over a mean of 16 months, the composite of acute exacerbation, respiratory hospitalisation or death was lower with 18 mg (HR 0.56, 95% CI 0.33 to 0.94), and time to death was longer with both doses (HR 0.40 and 0.28). Discontinuation for adverse events was not higher than placebo.

The direction is consistent with the overall trial, but this is a subgroup analysis, the FVC result was not significant, and mortality was not the primary endpoint. It supports including nerandomilast in discussions with respiratory colleagues once it is available; regulatory status in India is unknown.

• Discuss antifibrotic options with respiratory colleagues for autoimmune ILD that is progressing despite immunosuppression.
• Note that the FVC benefit in this subgroup was not statistically significant.
• Read the mortality finding as hypothesis-supporting, as it came from a subgroup and a secondary endpoint.
• Check local availability and regulatory status before considering nerandomilast.

Why it matters

Progressive fibrosis in connective tissue disease has few options, so even subgroup signals shape referral.

Don't overread it

This is a subgroup analysis; the primary lung function difference was not significant and mortality was secondary.

The statistics, in plain English

FVC differences of about 45 mL with intervals from about −21 to 113 mL mean no clear lung function benefit in this subgroup. Hazard ratios for death are large but come from few events and a subgroup, which tends to exaggerate effects.

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