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Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease
Journal article   Open access   Peer reviewed

Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease

Yannick Allanore, Dinesh Khanna, Vanessa Smith, Martin Aringer, Anna-Maria Hoffmann-Vold, Masataka Kuwana, Peter A Merkel, Christian Stock, Steven Sambevski, Christopher P Denton, …
Rheumatology, Vol.63(3), pp.639-647
03/01/2024
DOI: 10.1093/rheumatology/kead280
PMCID: PMC10907814
PMID: 37294870
url
https://doi.org/10.1093/rheumatology/kead280View
Published (Version of record) Open Access

Abstract

Objectives: To investigate the course of interstitial lung disease (ILD) and the effects of nintedanib in patients with limited cutaneous systemic sclerosis (lcSSc). Methods: In the SENSCIS trial, patients with SSc-ILD were randomised to receive nintedanib or placebo. Patients who completed the SENSCIS trial were eligible to enter SENSCIS-ON, in which all patients received open-label nintedanib. Results: Among 277 patients with lcSSc treated in the SENSCIS trial, the rate (SE) of decline in FVC (mL/year) over 52 weeks was -74.5 (19.2) in the placebo group and -49.1 (19.8) in the nintedanib group (difference: 25.3 [95% CI -28.9, 79.6]). Among 249 patients with data at week 52, mean (SE) changes in FVC at week 52 were -86.4 (21.1) mL in the placebo group and -39.1 (22.2) mL in the nintedanib group. Among 183 patients with lcSSc who participated in SENSCIS-ON and had data at week 52, mean (SE) changes in FVC from baseline to week 52 of SENSCIS-ON were -41.5 (24.0) mL in patients who took placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON and -45.1 (19.1) mL in patients who took nintedanib in the SENSCIS trial and continued it in SENSCIS-ON. Conclusion: Patients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD.

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