Timothy M Dempsey1, Lindsey R Sangaralingham2,3, Xiaoxi Yao4, Darshak Sanghavi3, Nilay D Shah2,4, Andrew H Limper1,2. 1. 1 Department of Pulmonary and Critical Care Medicine. 2. 2 Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, and. 3. 3 OptumLabs, Cambridge, Massachusetts. 4. 4 Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota; and.
Abstract
Rationale: Since their approval, there has been no real-world or randomized trial evidence evaluating the effect of the antifibrotic medications pirfenidone and nintedanib on clinically important outcomes such as mortality and hospitalizations. Objectives: To evaluate the clinical effectiveness of the antifibrotic medications pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis. Methods: Using a large U.S. insurance database, we identified 8,098 patients with idiopathic pulmonary fibrosis between October 1, 2014 and March 1, 2018. A one-to-one propensity score-matched cohort was created to compare patients treated with antifibrotic medications (n = 1,255) with those not on treatment (n = 1,255). The primary outcome was all-cause mortality. The secondary outcome was acute hospitalizations. Subgroup analyses were performed to evaluate mortality differences by drug. Measurements and Main Results: The use of antifibrotic medications was associated with a decreased risk of all-cause mortality (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62-0.98; P value = 0.034). However, this association was present only through the first 2 years of treatment. There was also a decrease in acute hospitalizations in the treated cohort (HR, 0.70; 95% CI, 0.61-0.80; P value <0.001). There was no significant difference in all-cause mortality between patients receiving pirfenidone and those on nintedanib (HR, 1.14; 95% CI, 0.79-1.65; P = 0.471). Conclusions: Among patients with idiopathic pulmonary fibrosis, antifibrotic agents may be associated with a lower risk of all-cause mortality and hospitalization compared with no treatment. Future research should test the hypothesis that these treatments reduce early, but not long-term, mortality as demonstrated in our study.
Rationale: Since their approval, there has been no real-world or randomized trial evidence evaluating the effect of the antifibrotic medications pirfenidone and nintedanib on clinically important outcomes such as mortality and hospitalizations. Objectives: To evaluate the clinical effectiveness of the antifibrotic medications pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis. Methods: Using a large U.S. insurance database, we identified 8,098 patients with idiopathic pulmonary fibrosis between October 1, 2014 and March 1, 2018. A one-to-one propensity score-matched cohort was created to compare patients treated with antifibrotic medications (n = 1,255) with those not on treatment (n = 1,255). The primary outcome was all-cause mortality. The secondary outcome was acute hospitalizations. Subgroup analyses were performed to evaluate mortality differences by drug. Measurements and Main Results: The use of antifibrotic medications was associated with a decreased risk of all-cause mortality (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62-0.98; P value = 0.034). However, this association was present only through the first 2 years of treatment. There was also a decrease in acute hospitalizations in the treated cohort (HR, 0.70; 95% CI, 0.61-0.80; P value <0.001). There was no significant difference in all-cause mortality between patients receiving pirfenidone and those on nintedanib (HR, 1.14; 95% CI, 0.79-1.65; P = 0.471). Conclusions: Among patients with idiopathic pulmonary fibrosis, antifibrotic agents may be associated with a lower risk of all-cause mortality and hospitalization compared with no treatment. Future research should test the hypothesis that these treatments reduce early, but not long-term, mortality as demonstrated in our study.
Authors: Sydney B Montesi; Jolene H Fisher; Fernando J Martinez; Moisés Selman; Annie Pardo; Kerri A Johannson Journal: Am J Respir Crit Care Med Date: 2020-08-15 Impact factor: 21.405
Authors: Maksim V Plikus; Xiaojie Wang; Sarthak Sinha; Elvira Forte; Sean M Thompson; Erica L Herzog; Ryan R Driskell; Nadia Rosenthal; Jeff Biernaskie; Valerie Horsley Journal: Cell Date: 2021-07-22 Impact factor: 66.850
Authors: Kelly M Pennington; Hayley J Dykhoff; Xiaoxi Yao; Lindsey R Sangaralingham; Nilay D Shah; Steve G Peters; Jason N Barreto; Raymund R Razonable; Cassie C Kennedy Journal: Ann Am Thorac Soc Date: 2021-03
Authors: Bryan T Kelly; Viengneesee Thao; Timothy M Dempsey; Lindsey R Sangaralingham; Stephanie R Payne; Taylor T Teague; Teng Moua; Nilay D Shah; Andrew H Limper Journal: BMC Pulm Med Date: 2021-07-17 Impact factor: 3.317