CO13 - Effect of nerandomilast on risk of death in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)
Justin Oldham (United States)1; Shervin Assassi (United States)2; Arata Azuma (Japan)3; Vincent Cottin (France)4; Anna-Maria Hoffmann-Vold (Switzerland)5; Michael Kreuter (Germany)6; Toby M. Maher (UK)7; Luca Richeldi (Italy)8; Claudia Valenzuela (Spain)9; Marlies S. Wijsenbeek (Netherlands)10; Hui Gu (United States)11; Gerrit Weimann (Germany)12; Ivana Ritter (Germany)12; Susanne Stowasser (Germany)12; Donald F. Zoz (United States)11; Fernando J. Martinez (United States)13;
1 - Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, USA; 2 - Division of Rheumatology, McGovern Medical School, UTHealth Houston, Houston, Texas, USA; 3 - Clinical Research Center, Mihara General Hospital, Saitama, Japan, and Nippon Medical School, Tokyo, Japan; 4 - National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, UMR 754, ERN-LUNG, Lyon, France; 5 - Department of Rheumatology, Oslo University Hospital, Oslo, Norway, and Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; 6 - Center for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Center and Pulmonary, Critical Care & Sleep Medicine, Marienhaus Clinic Mainz, Mainz, Germany; 7 - Department of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA, and Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, London, UK; 8 - Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy; 9 - Pulmonology Department, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain; 10 - Center of Expertise for Interstitial Lung Diseases, Department of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands; 11 - Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA; 12 - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 13 - University of Massachusetts (UMass) Chan Medical School/UMass Memorial Health System, Worcester, Massachusetts, USA;
Keywords: Lung; Interstitial lung disease; Mortality;
Select the theme: Controversies in Sarcoidosis Treatment
Type: Original Papers
Presentation: Oral Communication
Introduction: In the FIBRONEER-IPF trial in patients with IPF and FIBRONEER-ILD trial in patients with PPF, nerandomilast 9 mg bid and 18 mg bid reduced decline in forced vital capacity (FVC) at week 52 versus placebo (primary endpoint).
Objectives: We assessed the effect of nerandomilast on time to death.
Materials and Methods: Data from FIBRONEER-IPF and FIBRONEER-ILD were pooled. The primary analysis of time to death was based on deaths (except deaths after lung transplant) that occurred until the final database lock, which took place after all patients had completed an end-of-treatment visit. We assessed time to death based on events that occurred while patients were on-treatment plus 7, 30, 60, or 90 days afterwards, time to death or lung transplant, and time to respiratory-related death.
Results: Among 2353 patients, mean exposure to trial medication was 15.0 months and mean observation period was 16.7 months. Overall, 2250 (95.6%) patients completed the planned observation period and had confirmed vital status. Compared with placebo, the hazard ratio for death was 0.67 (95% CI: 0.49, 0.90) for nerandomilast 9 mg bid and 0.57 (95% CI: 0.41, 0.78) for nerandomilast 18 mg bid. The risks of death while on-treatment and the risk of death or lung transplant were lower with nerandomilast versus placebo (Figure). Respiratory-related death occurred in 9.0%, 5.5% and 4.6% of patients in the placebo, nerandomilast 9 mg bid and nerandomilast 18 mg bid groups, respectively, giving hazard ratios of 0.59 (95% CI: 0.40, 0.86) for nerandomilast 9 mg bid and 0.51 (95% CI: 0.34, 0.77) for nerandomilast 18 mg bid.
Conclusions: Based on pooled data from the FIBRONEER trials, nerandomilast was associated with a reduced risk of death. Analyses of on-treatment data, risk of death or lung transplant, and risk of respiratory-related death supported the robustness of this finding.