PO104 - Efficacy and safety of nerandomilast in the FIBRONEER trials in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)
Justin M. 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; Daniel Wachtlin (Germany)11; Gerrit Weimann (Germany)12; Ivana Ritter (Germany)12; Donald F. Zoz (United States)13; Fernando J. Martinez (United States)14;
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 Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 12 - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 13 - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA; 14 - University of Massachusetts (UMass) Chan Medical School/UMass Memorial Health System, Worcester, Massachusetts, USA;
Keywords: Lung; Pulmonary fibrosis; Interstitial lung disease;
Select the theme: Controversies in Sarcoidosis Treatment
Type: Original Papers
Presentation: Poster Presentation
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 reduced decline in forced vital capacity (FVC) over 52 weeks versus placebo (primary endpoint).
Objectives: Assess the efficacy and safety of nerandomilast in patients with IPF or PPF.
Materials and Methods: Data from the final database locks of the FIBRONEER-IPF and FIBRONEER-ILD trials were pooled.
Results: 2353 patients received ≥1 dose of trial drug. Mean exposure to trial drug was 15.0 months. Mean observation time was 16.7 months. Adjusted mean (SE) changes in FVC (mL) at week 76 were −243.3 (11.7) with placebo, −141.8 (11.6) with nerandomilast 9 mg bid (difference vs placebo: 101.4 [95% CI: 69.1, 133.8]) and −138.9 (11.6) with nerandomilast 18 mg (difference vs placebo: 104.4 [95% CI: 72.0, 136.8]). The composite outcome of acute exacerbation of ILD, hospitalization for respiratory cause, or death was experienced by 31.3% of the placebo group, 26.2% of the nerandomilast 9 mg bid group (hazard ratio [HR] vs placebo: 0.84 [95% CI: 0.69, 1.01]) and 26.3% of the nerandomilast 18 mg bid group (HR vs placebo: 0.85 [95% CI: 0.71, 1.03]). Deaths occurred in 13.5% of the placebo group, 9.2% of the nerandomilast 9 mg bid group (HR vs placebo: 0.67 [95% CI: 0.49, 0.90]) and 7.7% of the nerandomilast 18 mg bid group (HR vs placebo: 0.57 [95% CI: 0.41, 0.78]). Adverse events led to discontinuation of trial medication in 12.7% of the placebo group, 12.7% of the nerandomilast 9 mg bid group, and 14.2% of the nerandomilast 18 mg bid group. The most frequent adverse event was diarrhea.
Conclusions: In the FIBRONEER trials in patients with pulmonary fibrosis, nerandomilast slowed decline in lung function, reduced mortality, and had a favorable safety and tolerability profile.