Nerandomilast may slow lung function decline in idiopathic pulmonary fibrosis

Treatment with nerandomilast helps preserve lung function in patients with idiopathic pulmonary fibrosis, as shown in the phase III FIBRONEER-IPF trial.

FIBRONEER-IPF included 1,177 patients with IPF, of which 77.7 percent had background antifibrotic therapy (nintedanib or pirfenidone) at enrolment. These patients were randomly assigned to receive treatment with nerandomilast at a dose of 18 mg twice daily, 9 mg twice daily, or placebo.

Researchers assessed the absolute change from baseline in forced vital capacity (FVC) at week 52 as the primary endpoint.

At week 52, FVC decreased by 114.7 ml (95 percent confidence interval [CI], −141.8 to −87.5) in the nerandomilast 18-mg group, 138.6 ml (95 percent CI, −165.6 to −111.6) in the nerandomilast 9-mg group, and −183.5 ml (95 percent CI, −210.9 to −156.1) in the placebo group.

Both doses of nerandomilast were associated with smaller but significant reductions in FVC decline compared with placebo. Specifically, the 18-mg dose resulted in an adjusted difference of 68.8 ml (95 percent CI, 30.3–107.4; p<0.001), while the 9-mg dose, in an adjusted difference of 44.9 ml (95 percent CI, 6.4–83.3; p=0.02).

As for safety, diarrhoea was the most frequent adverse event in the nerandomilast groups, occurring in 41.3 percent of patients in the 18-mg group and 31.1 percent in the 9-mg group as opposed to only 16.0 percent in the placebo group. Serious adverse events were comparable across the three treatment groups.