Effect of Nerandomilast in Subgroups of Patients with Idiopathic Pulmonary Fibrosis (IPF) in the FIBRONEER-IPF trial*

Introduction: Nerandomilast is a preferential inhibitor of phosphodiesterase 4B with antifibrotic and immunomodulatory effects. In the Phase III FIBRONEER-IPF trial in patients with IPF, nerandomilast significantly reduced the decline in forced vital capacity (FVC) over 52 weeks. Aim: To assess the efficacy of nerandomilast in subgroups by baseline characteristics in the FIBRONEER-IPF trial. Methods: Patients with IPF were randomised 1:1:1 to receive nerandomilast 9 mg bid, nerandomilast 18 mg bid, or placebo, stratified by background antifibrotic therapy (nintedanib/pirfenidone vs none). In pre-specified analyses, we assessed the absolute change from baseline in FVC (mL) at week 52 in subgroups by sex, age (