Nintedanib for systemic sclerosis–associated interstitial lung disease
New England Journal of Medicine May 24, 2019
Distler O, et al. - In patients with interstitial lung disease (ILD) associated with systemic sclerosis, researchers studied the effectiveness and safety of nintedanib [a tyrosine kinase inhibitor]. For this randomized, double-blind, placebo-controlled trial, participants who had systemic sclerosis with an onset of the first non-Raynaud’s symptom within the past seven years and a high-resolution computed tomographic scan that revealed fibrosis affecting at least 10% of the lungs were randomly assigned, in a 1:1 ratio, to receive 150 mg of nintedanib, administered orally twice daily, or placebo. At least one dose of nintedanib or placebo was given to a total of 576 patients. Investigators found that the annual rate of decline in forced vital capacity was lower with nintedanib than with placebo among patients with ILD associated with systemic sclerosis. There was no clinical benefit of nintedanib for other systematic sclerosis manifestations. Nintedanib's adverse event profile observed in this study was similar to that observed in idiopathic pulmonary fibrosis patients. In 75.7% of patients in the nintedanib group and 31.6% of those in the placebo group, diarrhea, the most common adverse event, was reported.
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