Luca Richeldi1, Bruno Crestani2, Arata Azuma3, Martin Kolb4, Moisés Selman5, Wibke Stansen6, Manuel Quaresma7, Susanne Stowasser7, Vincent Cottin8. 1. Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: luca.richeldi@policlinicogemelli.it. 2. APHP, Service de Pneumologie A, Hôpital Bichat, DHU FIRE, INSERM, Unité 1152, Université Paris Diderot, Paris, France. 3. Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan. 4. McMaster University and St. Joseph's Healthcare, Hamilton, Ontario, Canada. 5. Instituto Nacional de Enfermedades Respiratorias "Ismael Cosio Villegas", Mexico City, Mexico. 6. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. 7. Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany. 8. National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, Lyon, France.
Abstract
BACKGROUND: We explored the impact of FVC decline on subsequent FVC decline and mortality in the INPULSIS trials of nintedanib in patients with IPF and their open-label extension, INPULSIS-ON. METHODS: Changes in FVC and mortality between weeks 24 and 52 of the INPULSIS trials were assessed in patients with an increase/no decline in FVC % predicted and with declines in FVC <10% and ≥10% predicted from baseline to week 24. Changes in FVC and mortality in the first year of INPULSIS-ON were assessed in patients treated with nintedanib in the preceding INPULSIS trial who did and did not have a decline in FVC ≥10% predicted at week 52. RESULTS: The proportion of placebo-treated patients with decline in FVC ≥10% predicted between weeks 24 and 52 of INPULSIS was similar in patients with increase/no decline in FVC and with decline in FVC ≥10% predicted between baseline and week 24 (20.5% and 18.9%, respectively). Mortality between weeks 24 and 52 of INPULSIS was higher in patients with FVC decline ≥10% predicted than <10% predicted between baseline and week 24 (13.2% vs 3.8%). Among nintedanib-treated patients in INPULSIS who had decline in FVC ≥10% versus <10% predicted at week 52, 34.0% versus 21.4%, respectively, had decline in FVC ≥10% predicted in the first year of INPULSIS-ON. Mortality in the first year of INPULSIS-ON was 21.3% vs 5.7% in these groups, respectively. CONCLUSIONS: Decline in FVC did not predict FVC decline but was associated with mortality in patients with IPF.
BACKGROUND: We explored the impact of FVC decline on subsequent FVC decline and mortality in the INPULSIS trials of nintedanib in patients with IPF and their open-label extension, INPULSIS-ON. METHODS: Changes in FVC and mortality between weeks 24 and 52 of the INPULSIS trials were assessed in patients with an increase/no decline in FVC % predicted and with declines in FVC <10% and ≥10% predicted from baseline to week 24. Changes in FVC and mortality in the first year of INPULSIS-ON were assessed in patients treated with nintedanib in the preceding INPULSIS trial who did and did not have a decline in FVC ≥10% predicted at week 52. RESULTS: The proportion of placebo-treated patients with decline in FVC ≥10% predicted between weeks 24 and 52 of INPULSIS was similar in patients with increase/no decline in FVC and with decline in FVC ≥10% predicted between baseline and week 24 (20.5% and 18.9%, respectively). Mortality between weeks 24 and 52 of INPULSIS was higher in patients with FVC decline ≥10% predicted than <10% predicted between baseline and week 24 (13.2% vs 3.8%). Among nintedanib-treated patients in INPULSIS who had decline in FVC ≥10% versus <10% predicted at week 52, 34.0% versus 21.4%, respectively, had decline in FVC ≥10% predicted in the first year of INPULSIS-ON. Mortality in the first year of INPULSIS-ON was 21.3% vs 5.7% in these groups, respectively. CONCLUSIONS: Decline in FVC did not predict FVC decline but was associated with mortality in patients with IPF.
Authors: Claudia Valenzuela; Sebastiano Emanuele Torrisi; Nicolas Kahn; Manuel Quaresma; Susanne Stowasser; Michael Kreuter Journal: Respir Res Date: 2020-01-06
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Authors: Toby M Maher; Kevin K Brown; Michael Kreuter; Anand Devaraj; Simon L F Walsh; Lisa H Lancaster; Elizabeth A Belloli; Maria Padilla; Juergen Behr; Rainer-Georg Goeldner; Kay Tetzlaff; Rozsa Schlenker-Herceg; Kevin R Flaherty Journal: Eur Respir J Date: 2022-02-03 Impact factor: 16.671