Abstract

<b>Background:</b> The Envisia Genomic Classifier (EGC) is a molecular diagnostic test (available in the U.S. and expected soon outside the U.S.) that identifies a genomic UIP pattern in transbronchial biopsies to aid in the diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and other progressive fibrotic lung diseases. Combination therapy with corticosteroids and nonsteroidal immunosuppressants is known to be harmful in patients with IPF. <b>Aims and Objectives:</b> We hypothesized that patients with an EGC (+) result treated with combination therapy would show a greater decline in forced vital capacity (FVC) compared to EGC (+) patients not treated with combination therapy. <b>Methods:</b> Patients in the BRAVE study who underwent pathological evaluation for an undiagnosed ILD, had an EGC result, and had serial FVCs (one at least six months after baseline) were identified. Retrospective analyses of EGC result, change in FVC, and treatment for ILD were performed. <b>Results:</b> 73 of 135 (54%) patients had an EGC (+) result. This group had a baseline FVC of 66.9% predicted and an absolute 1-year decline of 3.7%. EGC (+) patients exposed to both corticosteroids and a nonsteroidal immunosuppressant showed a 1-year decline of 9.4% compared to a decline of 1.9% in EGC (+) patients not taking both (p=0.01). EGC (–) patients did not show a significant difference in 1-year FVC change for those taking combination therapy (1.9% decline) compared to those not treated with&nbsp;combination therapy&nbsp;(0.3% increase, p = 0.4). <b>Conclusions:</b> An EGC (+) result may help identify patients in whom combination immunosuppressive therapy is harmful.

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