RT Journal Article
SR Electronic
T1 Changes in FVC in the SENSCIS trial of nintedanib in patients with systemic sclerosis-associated ILD (SSc-ILD)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP RCT1882
DO 10.1183/13993003.congress-2019.RCT1882
VO 54
IS suppl 63
A1 Kristin B. Highland
A1 Arata Azuma
A1 Aryeh Fischer
A1 Masataka Kuwana
A1 Toby M. Maher
A1 Maureen D. Mayes
A1 Ganesh Raghu
A1 Mannaig Girard
A1 Margarida Alves
A1 Martina Gahlemann
A1 Oliver Distler
YR 2019
UL http://erj.ersjournals.com/content/54/suppl_63/RCT1882.abstract
AB Background: In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in FVC (mL/year) over 52 weeks vs placebo (primary endpoint).Aims: To assess effects of nintedanib on changes in FVC.Methods: We assessed the cumulative distribution of subjects by change in FVC % predicted at week 52 in the SENSCIS trial (based on subjects with a week 52 value). The proportions of subjects with absolute declines in FVC >5% and >10% predicted and relative declines in FVC (mL) >5% and >10% at week 52 were analysed using a worst observation carried forward approach.Results: At baseline, mean (SD) FVC was 72.4 (16.8) % predicted in the nintedanib group (n=288) and 72.7 (16.6) % predicted in the placebo group (n=288). In the nintedanib and placebo groups, respectively, absolute declines in FVC >5% predicted were seen in 20.6% and 28.5% (OR 0.65 [95% CI 0.44, 0.96]; p=0.03) and absolute declines in FVC >10% predicted in 7.0% and 8.3% of subjects (OR 0.82 [0.44, 1.52]; p=0.53). Relative declines in FVC (mL) >5% were seen in 33.1% and 43.4% (OR 0.65 [0.46, 0.91]; p=0.01) and relative declines in FVC (mL) >10% in 16.7% and 18.1% (OR 0.91 [0.59, 1.41]; p=0.68) of subjects, respectively.Conclusions: In patients with SSc-ILD, treatment with nintedanib is associated with a lower probability of a >5% decline in FVC (mL or % predicted) over 52 weeks compared to placebo.FootnotesCite this article as: European Respiratory Journal 2019; 54: Suppl. 63, RCT1882.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).