Outcomes following decline in forced vital capacity in patients with idiopathic pulmonary fibrosis: Results from the INPULSIS and INPULSIS-ON trials of nintedanib. (September 2019)

• Record Type: Journal Article
• Authors: Richeldi, Luca; Crestani, Bruno; Azuma, Arata; Kolb, Martin; Selman, Moisés; Stansen, Wibke; Quaresma, Manuel; Stowasser, Susanne; Cottin, Vincent
• Is Part Of: Respiratory medicine. Volume 156(2019)
• Page Start: 20
• Page End: 25
• Publication Date: 2019-09
• Subjects: Interstitial lung disease; Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2019.08.002
• Languages: English
• ISSNs: 0954-6111

Abstract

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. Highlights: We investigated FVC decline and mortality in the INPULSIS trials. FVC decline over 24 weeks did not predict FVC decline between weeks 24 and 52. FVC decline ≥10% predicted over 24 weeks was associated with mortality at week 52. These data do not support stopping nintedanib based solely on FVC decline.