Faculty, Staff and Student Publications
Publication Date
3-21-2025
Journal
Arthritis Research & Therapy
Abstract
We used data from the SENSCIS and SENSCIS-ON trials to assess decline in forced vital capacity (FVC) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) who received long-term treatment with nintedanib and the effect of switching patients from placebo to nintedanib. In the SENSCIS trial, patients were randomised to receive nintedanib or placebo until the last patient reached week 52 but for ≤ 100 weeks. In SENSCIS-ON, the extension to SENSCIS, all patients received open-label nintedanib. Per protocol, the off-treatment period between these trials was ≤ 12 weeks. We assessed the trajectory of FVC in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON (n = 197) and in patients who received placebo in SENSCIS and initiated nintedanib in SENSCIS-ON (n = 231). The last on-treatment measurement in SENSCIS and the baseline measurement of SENSCIS-ON were considered anchor measurements. In patients who received nintedanib in SENSCIS, the mean decline in FVC in the 52 weeks prior to the last on-treatment measurement in SENSCIS was - 41.5 mL and the mean decline in FVC from baseline to week 52 of SENSCIS-ON was - 58.3 mL. In patients who received placebo in SENSCIS, the mean decline in FVC in the 52 weeks prior to the last on-treatment measurement in SENSCIS was - 96.8 mL and the mean decline in FVC from baseline to week 52 of SENSCIS-ON (when patients received nintedanib) was - 42.8 mL. These findings illustrate the progressive nature of SSc-ILD and support the efficacy of nintedanib in slowing decline in lung function over the long term.
Keywords
Adult, Aged, Female, Humans, Male, Middle Aged, Indoles, Lung Diseases, Interstitial, Scleroderma, Systemic, Treatment Outcome, Vital Capacity, Disease progression, Pulmonary fibrosis, Pulmonary function tests, Systemic scleroderma
DOI
10.1186/s13075-025-03524-9
PMID
40119463
PMCID
PMC11927141
PubMedCentral® Posted Date
3-21-2025
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes