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Objective Nintedanib, an intracellular inhibitor of tyrosine kinase, has been approved by the.
Food and Drug Administration to slow the decline in lung function in patients with systemic sclerosis-associated interstitial lung disease ( ILD .
Methods : The INBUILD trial enrolled patients with non-idiopathic pulmonary fibrosis with fibrotic ILD , diffuse fibrotic lung disease >10% on high-resolution computed tomography , forced vital capacity percent predicted (FVC%) ≥45 % , and lung Carbon monoxide percent predicted ≥ 30% to < 80.
RESULTS : Among 170 patients with autoimmune disease-related ILD , the rate of decline in FVC at 52 weeks was -79 ml/ year in the nintedanib group and -176 ml/ year in the placebo group (difference 107 ml/ year [95%] Confidence interval 22, 182]; nominal P=012.
CONCLUSIONS : In the INBUILD trial, nintedanib slowed the rate of decline in FVC in patients with progressive fibrotic autoimmune disease-associated ILD , with adverse events manageable in most patient.
Source: Matteson, EL, Kelly,.