Effects of nintedanib in patients with SSc-ILD and preserved and highly impaired lung function

Abstract

Introduction: In the SENSCIS trial in patients with systemic sclerosis-associated ILD (SSc-ILD), nintedanib reduced the rate of decline in FVC over 52 weeks compared with placebo. Aim: Assess the effects of nintedanib in patients with SSc-ILD and preserved and highly impaired lung function. Methods: We analysed the rate of decline in FVC (mL/year) over 52 weeks in subgroups with FVC ≤90% vs >90% predicted and FVC ≤60% vs >60% predicted at baseline in the SENSCIS trial. Results: Of 576 patients treated with nintedanib or placebo, 14.1% had FVC >90% predicted and 26.2% had FVC ≤60% predicted at baseline. The rate of decline in FVC in the placebo group was numerically greater in patients with FVC ≤90% than >90% predicted and in patients with FVC ≤60% than >60% predicted (Figure).The effect of nintedanib vs placebo on reducing the rate of decline in FVC was similar between patients with FVC ≤90% vs >90% predicted (Figure). The effect of nintedanib vs placebo on reducing the rate of decline in FVC was numerically more pronounced in patients with FVC >60% than ≤60% predicted, but the exploratory interaction p-value did not indicate heterogeneity in the treatment effect between subgroups (Figure). Conclusion: In the SENSCIS trial, the benefit of nintedanib on reducing the rate of decline in FVC was consistent in patients with preserved FVC and in patients with advanced impairment in FVC at baseline.