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

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 categori...

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Veröffentlicht in:Arthritis & rheumatology (Hoboken, N.J.) Jg. 73; H. 4; S. 671 - 676
Hauptverfasser: Maher, Toby M., Mayes, Maureen D., Kreuter, Michael, Volkmann, Elizabeth R., Aringer, Martin, Castellvi, Ivan, Cutolo, Maurizio, Stock, Christian, Schoof, Nils, Alves, Margarida, Raghu, Ganesh
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Wiley Subscription Services, Inc 01.04.2021
John Wiley and Sons Inc
Schlagworte:
Adult
Aged
Confidence intervals
Death
Disease Progression
Double-Blind Method
Double-blind studies
Female
Full Length
Humans
Indoles - pharmacology
Indoles - therapeutic use
Lung - drug effects
Lung - physiopathology
Lung diseases
Lung Diseases, Interstitial - drug therapy
Lung Diseases, Interstitial - etiology
Lung Diseases, Interstitial - physiopathology
Male
Middle Aged
Mortality
Placebos
Protein Kinase Inhibitors - pharmacology
Protein Kinase Inhibitors - therapeutic use
Respiratory function
Scleroderma
Scleroderma, Systemic - complications
Scleroderma, Systemic - physiopathology
Systemic Sclerosis
Treatment Outcome
ISSN:2326-5191, 2326-5205, 2326-5205
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Zusammenfassung: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.
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Dr. Maher has received consulting fees, speaking fees, and/or honoraria from AstraZeneca, Blade Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Galápagos, GlaxoSmithKline, Indalo, Pliant, Respivant, Roche, and Theravance (less than $10,000 each). Dr. Mayes has received consulting fees, speaking fees, and/or honoraria from Boehringer Ingelheim, Corbus, Eicos Sciences, Galápagos, and Mitsubishi Tanabe (less than $10,000 each). Dr. Kreuter has received consulting fees, speaking fees, and/or honoraria from Boehringer Ingelheim and Roche (less than $10,000 each). Dr. Volkmann has received consulting fees, speaking fees, and/or honoraria from Boehringer Ingelheim (more than $10,000). Dr. Aringer has received consulting fees, speaking fees, and/or honoraria from Boehringer Ingelheim (less than $10,000). Dr. Castellvi has received consulting fees, speaking fees, and/or honoraria from Boehringer Ingelheim, Bristol Myers Squibb, Janssen‐Cilag, Roche, and Sanofi (less than $10,000 each). Dr. Cutolo has received consulting fees, speaking fees, and/or honoraria from Bristol Myers Squibb (less than $10,000). Drs. Stock, Schoof, and Alves are employees of Boehringer Ingelheim. Dr. Raghu has received consulting fees, speaking fees, and/or honoraria from Roche‐Genentech (less than $10,000) and from Boehringer Ingelheim (more than $10,000).
Supported by Boehringer Ingelheim.
ClinicalTrials.gov identifier: NCT02597933.
ISSN:2326-5191
2326-5205
2326-5205
DOI:10.1002/art.41576