CO12 - 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
Sonye K Danoff (United States)1; Ayodeji Adegunsoye (United States)2; Min Cao (China)3; Man Pyo Chung (Korea, South)4; Yasuhiko Nishioka (Japan)5; Markus Polke (Germany)6; Hui Gu (United States)7; Kamila Sroka-Saidi (Germany)8; Susanne Stowasser (Germany)9; Marlies S Wijsenbeek (Netherlands)10; Divya Patel (Germany)11;
1 - Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2 - Section of Pulmonary and Critical Care Medicine, University of Chicago, Chicago, IL, USA; 3 - Department of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China; 4 - Pulmonary and Critical Care Medicine, Samsung Medical Centre, Seoul, Republic of Korea; 5 - Department of Respiratory Medicine and Rheumatology, Tokushima University, Tokushima, Japan; 6 - Center for Interstitial and Rare Lung Diseases, Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany; 7 - Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 8 - Boehringer Ingelheim International GmbH, Biberach an der Riss, Germany; 9 - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 10 - Center of Expertise for Interstitial Lung Diseases, Department of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands; 11 - Boehringer Ingelheim International GmbH;
Keywords: Lung; Pulmonary fibrosis; Interstitial lung disease;
Select the theme: Controversies in Sarcoidosis Treatment
Type: Original Papers
Presentation: Oral Communication

Introduction: 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).

Objectives: To assess the effect of nerandomilast in subgroups by FVC % predicted at baseline in these trials.

Materials and 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).

Figure. Change in FVC (mL) at week 52 in subgroups by FVC % predicted at baseline of the FIBRONEER-IPF and FIBRONEER-ILD trials.