Effects of nintedanib in patients with systemic sclerosis-associated ILD (SSc-ILD) and differing FVC at baseline: the SENSCIS trial

Abstract

Background: In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the annual rate of decline in FVC (mL/year) vs placebo (primary endpoint). There was no significant difference between treatment groups in change from baseline in modified Rodnan skin score (mRSS) or St George’s Respiratory Questionnaire (SGRQ) total score (key secondary endpoints) at week 52. Aim: To assess the efficacy of nintedanib in subgroups by FVC % predicted at baseline. Methods: Subjects with SSc-ILD with ≥10% fibrosis of the lungs on HRCT and FVC ≥40% predicted were randomised to receive nintedanib 150 mg bid or placebo. We analysed the primary and key secondary endpoints in subgroups by baseline FVC Results: 201 (69.8%) subjects in the nintedanib group and 196 (68.1%) in the placebo group had FVC Conclusion: In patients with SSc-ILD, nintedanib was observed to reduce ILD progression irrespective of FVC % predicted at baseline. Table.