Progression of systemic sclerosis-associated ILD (SSc-ILD) and effect of nintedanib in subgroups by monocyte and neutrophil counts

Abstract

<b>Background:</b> Monocyte and neutrophil counts have been associated with outcomes in IPF and SSc-ILD. <b>Aim:</b> To assess ILD progression and the effect of nintedanib in subgroups by monocyte and neutrophil count at baseline in subjects with SSc-ILD in the SENSCIS trial. <b>Methods:</b> Subjects with SSc with first non-Raynaud symptom in the prior ≤7 years, extent of fibrotic ILD on HRCT ≥10% and FVC ≥40% predicted were randomised to receive nintedanib or placebo. We analysed the rate of decline in FVC (mL/year) over 52 weeks in subgroups by monocyte count and neutrophil count &lt; vs ≥ the mean at baseline. <b>Results:</b> Among 573 patients, at baseline, mean (SD) monocyte count was 0.40 (0.21) x 109/L and neutrophil count was 5.8 (2.5) x 109/L. The rate of decline in FVC over 52 weeks was numerically greater in patients with monocyte count ≥ vs &lt; the mean but similar between patients with neutrophil count &lt; and ≥ the mean (Figure). Exploratory interaction p-values did not indicate heterogeneity in the effect of nintedanib vs placebo between subgroups by monocyte or neutrophil count (Figure). <b>Conclusion:</b> Patients with SSc-ILD in the SENSCIS trial with higher monocyte count at baseline had a numerically greater FVC decline over 52 weeks. Nintedanib reduced the rate of decline in FVC irrespective of monocyte or neutrophil count at baseline.