TY - JOUR 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 DO - 10.1183/13993003.congress-2019.RCT1882 VL - 54 IS - suppl 63 SP - RCT1882 AU - Kristin B. Highland AU - Arata Azuma AU - Aryeh Fischer AU - Masataka Kuwana AU - Toby M. Maher AU - Maureen D. Mayes AU - Ganesh Raghu AU - Mannaig Girard AU - Margarida Alves AU - Martina Gahlemann AU - Oliver Distler Y1 - 2019/09/28 UR - http://erj.ersjournals.com/content/54/suppl_63/RCT1882.abstract N2 - 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). ER -