Patients taking the antifibrotic medications nintedanib and pirfenidone for idiopathic pulmonary fibrosis (IPF) had reduced all-cause mortality and hospitalizations for up to 2 years compared with a matched untreated cohort, according to a study published in the American Journal of Respiratory and Critical Care Medicine.

This real-world, retrospective cohort analysis used a large US insurance database to identify 8098 patients with IPF, who were then propensity-score matched 1:1 to compare patients treated with the antifibrotic medications nintedanib and pirfenidone (n=1255) with untreated patients (n=1255). The primary study end point was all-cause mortality, with a secondary end point of acute hospitalizations. Mortality differences by drug were evaluated using subgroup analysis.

The use of both antifibrotic medications was associated with a decreased all-cause mortality risk (treated vs untreated cohorts: 13.78 per 100 person-years vs 16.34 per 100 person-years; hazard ratio [HR], 0.77; 95% CI, 0.62-0.98; P =.034). However, this association only persisted through the initial 2 years of treatment. The treated cohort also showed a decreased acute hospitalization risk (46.70 per 100 person-years vs 62.44 per 100 person-years; HR, 0.70; 95% CI, 0.61-0.80; P <.001). No significant difference was observed in all-cause mortality between patients taking pirfenidone compared with those taking nintedanib (pirfenidone: 12.83 per 100 person-years vs nintedanib: 14.77 per 100 person-years; HR, 1.14; 95% CI, 0.79-1.65; P =.471). Sensitivity analyses to confirm findings all showed similar results to the primary findings.

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Limitations of this study included the dataset, which was limited to individuals enrolled in private and Medicare Advantage health plans with pharmaceutical benefits; possible confounding factors; and the researchers’ inability to confirm whether participants were taking medications as intended throughout the study period.

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Study investigators concluded, “Compared head-to-head, there was no difference in all-cause mortality between the medications. Further research is needed to test the hypothesis that these treatments reduce early but not long-term mortality as demonstrated in our study.”


Dempsey TM, Sangaralingham LR, Yao X, Sanghavi D, Shah ND, Limper AH. Clinical effectiveness of the anti-fibrotic medications for idiopathic pulmonary fibrosis [published online May 31, 2019]. Am J Respir Crit Care Med. doi:10.1164/rccm.201902-0456OC