Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis−Associated Interstitial Lung Disease : Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial
Maher, Toby M. (National Heart and Lung Institute. Imperial College London and NIHR Clinical Research Facility. Royal Brompton Hospital. London. UK. and Keck School of Medicine. University of Southern California)
Mayes, Maureen D. (University of Texas McGovern Medical School)
Kreuter, Micahel (Thoraxklinik. University of Heidelberg. and the German Center for Lung Research)
Volkmann, Elizabeth R. (University of California. David Geffen School of Medicine)
Aringer, Martin (University Medical Center and Faculty of Medicine Carl Gustav Carus. TU Dresden)
Castellvi, Ivan (Institut d'Investigació Biomèdica Sant Pau)
Cutolo, Maurizio (Istituto di Ricovero e Cura A Carattere Scientifico (IRCCS))
Stock, Christian (Boehringer Ingelheim Pharma GmbH & Co. KG)
Schoof, Nils (Boehringer Ingelheim International GmbH. Ingelheim am Rhein)
Alves, Margarida (Boehringer Ingelheim International GmbH. Ingelheim am Rhein)
Raghu, Ganesh (University of Washington)

Date:	2021
Abstract:	Objective: In the SENSCIS trial in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was undertaken to investigate the effects of nintedanib on categorical changes in FVC and other measures of ILD progression. Methods: In post hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC of ≥5% predicted or death and absolute decline in FVC of ≥10% predicted or death. Results: A total of 288 subjects received nintedanib and 288 subjects received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55. 7% and 66. 3% had any decline in FVC % predicted, 13. 6% and 20. 1% had a decline in FVC of >5% to ≤10% predicted, and 3. 5% and 5. 2% had a decline in FVC of >10% to ≤15% predicted; 34. 5% and 43. 8% had a decrease in FVC of ≥3. 3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23. 0% and 14. 9% had an increase in FVC of ≥3. 0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of ≥5% predicted or death with nintedanib versus placebo was 0. 83 (95% confidence interval [95% CI] 0. 66−1. 06) (P = 0. 14), and the HR for an absolute decline in FVC of ≥10% predicted was 0. 64 (95% CI 0. 43−0. 95) (P = 0. 029). Conclusion: These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Adult ; Aged ; Disease Progression ; Double-Blind Method ; Female ; Humans ; Indoles ; Lung ; Lung Diseases, Interstitial ; Male ; Middle Aged ; Protein Kinase Inhibitors ; Scleroderma, Systemic ; Treatment Outcome
Published in:	Arthritis and Rheumatology, Vol. 73 Núm. 4 (april 2021) , p. 671-676, ISSN 2326-5205

DOI: 10.1002/art.41576
PMID: 33142016

6 p, 488.2 KB

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