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Nintedanib for systemic sclerosis–associated interstitial lung disease

New England Journal of Medicine Jul 03, 2019

Distler O, et al. - Via a randomized, double-blind, placebo-controlled trial on 576 patients who had systemic sclerosis with an onset of the first non-Raynaud’s symptom within the past 7 years and a high-resolution computed tomographic scan that revealed fibrosis affecting at least 10% of the lungs, the researchers assessed the efficiency and safety of nintedanib in patients with interstitial lung disease (ILD, a common manifestation of systemic sclerosis and a leading cause of systemic sclerosis-related death) related to systemic sclerosis. No significant difference in the modified Rodnan skin score and the total score on the St. George’s Respiratory Questionnaire at week 52 could be ascertained among the trial groups (nintedanib and placebo group). The most common adverse event was diarrhea. In comparison to the placebo group, the annual rate of deterioration in forced vital capacity was lesser among patients with ILD associated with systemic sclerosis. No clinical advantage of nintedanib could be identified for other signs of systemic sclerosis. Also, as compared with patients with idiopathic pulmonary fibrosis, a similar adverse event profile of nintedanib was recognized.
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