B95-03 Effect of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) by Baseline Forced Vital Capacity: Subgroup Analyses of the FIBRONEER Trials

Abstract Rationale In the FIBRONEER-IPF trial in patients with IPF and the FIBRONEER-ILD trial in patients with PPF, nerandomilast 9 mg bid and 18 mg bid slowed disease progression, with a significant reduction in decline in FVC (mL) at week 52 versus placebo (the primary endpoint). We assessed the effect of nerandomilast in subgroups by FVC % predicted at baseline in these trials. Methods The FIBRONEER-IPF and FIBRONEER-ILD trials enrolled patients with FVC ≥45% predicted. In a post-hoc analysis, we assessed the change from baseline in FVC (mL) at week 52 across subgroups by categories of FVC % predicted at baseline. Treatment-by-subgroup interaction p-values were calculated to assess potential heterogeneity in the effect of nerandomilast versus placebo across the subgroups in each trial. Results Overall, 1177 and 1176 patients received trial medication in FIBRONEER-IPF and FIBRONEER-ILD, respectively. At baseline of FIBRONEER-IPF, 52 patients (4.4%) had FVC ≤50% predicted, 336 (28.5%) had FVC 50%-≤70% predicted, 505 (42.9%) had FVC 70%-≤90% predicted, and 284 (24.1%) had FVC 90% predicted. At baseline of FIBRONEER-ILD, 121 patients (10.3%) had FVC ≤50% predicted, 489 (41.6%) had FVC 50%-≤70% predicted, 442 (37.6%) had FVC 70%-≤90% predicted, and 124 (10.5%) had FVC 90% predicted. There was no evidence of heterogeneity in the effect of nerandomilast versus placebo on change from baseline in FVC (mL) at week 52 in subgroups by FVC % predicted at baseline in FIBRONEER-IPF (interaction p = 0.88 for nerandomilast 9 mg bid, p = 0.75 for nerandomilast 18 mg bid) or FIBRONEER-ILD (interaction p = 0.93 for nerandomilast 9 mg bid, p = 0.76 for nerandomilast 18 mg bid) (Figure). Conclusions In patients with IPF and PPF, the effect of nerandomilast on slowing disease progression was consistent irrespective of baseline FVC % predicted, including in patients with well-preserved FVC (90% predicted). This abstract is funded by: The FIBRONEER-IPF and FIBRONEER-ILD trials were supported by Boehringer Ingelheim.