Effect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosis

• Autor(a) principal: Nathan, Steven D.
• Data de Publicação: 2016
• Outros Autores: Albera, Carlo, Bradford, Williamson Z., Costabel, Ulrich, du Bois, Roland M., Fagan, Elizabeth A., Fishman, Robert S., Glaspole, Ian, Glassberg, Marilyn K., Glasscock, Kenneth F., King, Talmadge E., Jr., Lancaster, Lisa, Lederer, David J., Lin, Zhengning, Pereira, Carlos A. [UNIFESP], Swigris, Jeffrey J., Valeyre, Dominique, Noble, Paul W., Wells, Athol U.
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: http://dx.doi.org/10.1136/thoraxjnl-2015-207011; https://repositorio.unifesp.br/handle/11600/55994

Background The assessment of treatment response in idiopathic pulmonary fibrosis (IPF) is complicated by the variable clinical course. We examined the variability in the rate of disease progression and evaluated the effect of continued treatment with pirfenidone in patients who experienced meaningful progression during treatment. Methods The source population included patients enrolled in the ASCEND and CAPACITY trials (N=1247). Pearson's correlation coefficients were used to characterise the relationship between changes in FVC during consecutive 6-month intervals in the placebo population. Outcomes following a >= 10% decline in FVC were evaluated by comparing the proportion of patients in the pirfenidone and placebo groups who experienced a >= 10% decline in FVC or death during the subsequent 6 months. Results A weak negative correlation was observed between FVC changes during consecutive intervals in the placebo population (coefficient, -0.146, p<0.001), indicating substantial variability. Thirty-four (5.5%) and 68 (10.9%) patients in the pirfenidone and placebo groups, respectively, experienced a >= 10% decline in FVC by month 6. During the subsequent 6 months, fewer patients in the pirfenidone group compared with placebo experienced a >= 10% decline in FVC or death (5.9% vs 27.9%