Effects of nintedanib in patients with systemic sclerosis-associated ILD (SSc-ILD) and differing levels of lung function impairment

Abstract

<b>Background:</b> In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in FVC compared with placebo. <b>Aim:</b> To assess the efficacy of nintedanib in subgroups with differing lung function impairment. <b>Methods:</b> Subjects with SSc with first non-Raynaud symptom in the prior ≤7 years, extent of fibrotic ILD ≥10%, FVC ≥40% predicted and DLco 30–89% predicted were randomised to receive nintedanib or placebo. We analysed the rate of decline in FVC (mL/year) over 52 weeks by baseline FVC &lt;70% vs ≥70% predicted and DLco ≤50% vs &gt;50% predicted. <b>Results:</b> At baseline, 254/575 patients (44.2%) had FVC &lt;70% predicted and 259/568 (45.6%) had DLco ≤50% predicted. In the placebo group, the rate of decline in FVC was numerically greater in patients with FVC &lt;70% vs ≥70% predicted and with DLco ≤50% vs &gt;50% predicted. The effect of nintedanib vs placebo on reducing the rate of decline in FVC was numerically more pronounced in patients with FVC ≥70% vs &lt;70% predicted and with DLco ≤50% vs &gt;50% predicted, but exploratory interaction p-values did not indicate heterogeneity in the treatment effect between these subgroups. <b>Conclusion:</b> In the SENSCIS trial, patients with SSc-ILD with worse lung function impairment at baseline had a numerically greater rate of decline in FVC over 52 weeks. Nintedanib slowed decline in FVC irrespective of lung function impairment at baseline.