Efficacy and safety of nerandomilast in patients with autoimmune disease-related progressive pulmonary fibrosis in the FIBRONEER-ILD trial
Authors' conclusion
Consistent with the overall trial population, among patients with autoimmune ILDs in FIBRONEER-ILD, nerandomilast slowed progression of pulmonary fibrosis and was well tolerated.
Study context
- Population
- Patients with autoimmune disease-related ILDs and progressive pulmonary fibrosis in FIBRONEER-ILD
- Participants
- 325 autoimmune ILDs
- Comparison
- Nerandomilast 9 mg or 18 mg twice a day vs placebo
- Primary endpoint
- Change in forced vital capacity (FVC) (mL)
- Follow-up
- Week 52
Methodological detailsplacebo-controlled, three-arm
- Placebo-controlled
- Three-arm
Primary result
As reported in the abstract
Change in FVC (mL), adjusted mean
Placebo
−107.1
adjusted mean · SE 25.0 · mL
Nerandomilast 9 mg twice a day
−61.2
adjusted mean · SE 23.3 · mL
Nerandomilast 18 mg twice a day
−64.9
adjusted mean · SE 23.5 · mL
Each group vs placeboDifference, mL (95% CI)
Nerandomilast 9 mg twice a day
45.9(−20.8 to 112.6)
Nerandomilast 18 mg twice a day
42.2(−24.9 to 109.3)
Further findings
| Outcome | HR | |
|---|---|---|
| Time to first acute exacerbation of ILD, hospitalisation for respiratory cause, or death · whole trial (mean exposure 15.8 months)Nerandomilast 9 mg twice a dayvs Placebo | 0.66 (95% CI 0.40–1.10) | |
| Time to first acute exacerbation of ILD, hospitalisation for respiratory cause, or death · whole trial (mean exposure 15.8 months)Nerandomilast 18 mg twice a dayvs Placebo | 0.56 (95% CI 0.33–0.94) | |
| Time to death · whole trial (mean exposure 15.8 months)Nerandomilast 9 mg twice a dayvs Placebo | 0.40 (CI 0.17–0.94) | |
| Time to death · whole trial (mean exposure 15.8 months)Nerandomilast 18 mg twice a dayvs Placebo | 0.28 (CI 0.11–0.69) | |
| 0.10.31310Hazard ratio (log scale) |
Safety
AEs leading to treatment discontinuation · whole trial
Original publication
Efficacy and safety of nerandomilast in patients with autoimmune disease-related progressive pulmonary fibrosis in the FIBRONEER-ILD trial. Ann Rheum Dis. Published 30 April 2026. doi:10.
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