Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial. (16th September 2022)

• Record Type: Journal Article
• Authors: Denton, Christopher P; Goh, Nicole S; Humphries, Stephen M; Maher, Toby M; Spiera, Robert; Devaraj, Anand; Ho, Lawrence; Stock, Christian; Erhardt, Elvira; Alves, Margarida; Wells, Athol U
• Is Part Of: Rheumatology. Volume 62:Number 5(2023)
• Page Start: 1870
• Page End: 1876
• Publication Date: 2022-09-16
• Subjects: autoimmune diseases -- pulmonary fibrosis -- vital capacity; Rheumatism -- Periodicals; Rheumatology -- Periodicals; 616.723005
• DOI: 10.1093/rheumatology/keac535
• Languages: English
• ISSNs: 1462-0324

Abstract

Abstract: Objective: To assess associations between the extent of fibrotic interstitial lung disease (ILD) and forced vital capacity (FVC) at baseline and change in FVC over 52 weeks in patients with systemic sclerosis-associated ILD (SSc-ILD) in the SENSCIS trial. Material and methods: We used generalized additive models, which involve few assumptions and allow for interaction between non-linear effects, to assess associations between the extent of fibrotic ILD on high-resolution computed tomography (HRCT), and the interplay of extent of fibrotic ILD on HRCT and FVC % predicted, at baseline and FVC decline over 52 weeks. Results: In the placebo group ( n = 288), there was weak evidence of a modest association between a greater extent of fibrotic ILD at baseline and a greater decline in FVC % predicted at week 52 [r: –0.09 (95% CI –0.2, 0.03)]. Higher values of both the extent of fibrotic ILD and FVC % predicted at baseline tended to be associated with greater decline in FVC % predicted at week 52. In the nintedanib group ( n = 288), there was no evidence of an association between the extent of fibrotic ILD at baseline and decline in FVC % predicted at week 52 [r: 0.01 (95% CI: -0.11, 0.12)] or between the interplay of extent of fibrotic ILD and FVC % predicted at baseline and decline in FVC % predicted at week 52. Conclusions: Data from the SENSCIS trial suggest that patients with SSc-ILD are at risk of ILD progression and benefit from nintedanib largely irrespective of their extent of fibrotic ILD at baseline. Study registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02597933.