Nintedanib for systemic sclerosis–associated interstitial lung disease
N Engl J Med 2019;380:2518–28 doi: 10.1056/NEJMoa1903076
Distler et al. reported that the annual rate of decline in FVC through Week 52 was lower with nintedanib than with placebo among patients with ILD associated with SSc. No clinical benefit of nintedanib was observed for other manifestations of SSc. The safety profile of nintedanib was similar to that observed in patients with idiopathic pulmonary fibrosis.
In SSc-ILD patients, gastrointestinal AEs (e.g. diarrhoea) were more common in patients receiving nintedanib than those receiving placebo. The proportion of discontinuation of intervention due to an AE was higher in patients receiving nintedanib than those receiving placebo. The uncontrolled OLE study (NCT03313180) continued to provide long-term data on nintedanib therapy in patients with ILD associated with SSc.
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