| Title: |
Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease |
| Authors: |
Allanore, Yannick; Khanna, Dinesh; Smith, Vanessa; Aringer, Martin; Hoffmann-Vold, Anna-Maria; Kuwana, Masataka; Merkel, Peter A; Stock, Christian; Sambevski, Steven; Denton, Christopher P; SENSCIS trial, investigators |
| Source: |
Rheumatology (2023) (In press). |
| Publisher Information: |
Oxford University Press (OUP) |
| Publication Year: |
2023 |
| Collection: |
University College London: UCL Discovery |
| Subject Terms: |
antifibrotic agents; pulmonary fibrosis; pulmonary function tests; scleroderma; systemic |
| Description: |
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. TRIAL REGISTRATION: ClinicalTrials.gov (https://www.clinicaltrials.gov), NCT02597933 and NCT03313180. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10171964/7/Denton_Effects%20of%20nintedanib%20in%20patients%20with%20limited%20cutaneous%20systemic%20sclerosis%20and%20interstitial%20lung%20disease_AAM2.pdf; https://discovery.ucl.ac.uk/id/eprint/10171964/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10171964/7/Denton_Effects%20of%20nintedanib%20in%20patients%20with%20limited%20cutaneous%20systemic%20sclerosis%20and%20interstitial%20lung%20disease_AAM2.pdf; https://discovery.ucl.ac.uk/id/eprint/10171964/ |
| Rights: |
open |
| Accession Number: |
edsbas.C1FB876B |
| Database: |
BASE |