A real-world study of the dosing and tolerability of pirfenidone and its effect on survival in idiopathic pulmonary fibrosis.
Sahajal Dhooria, Ritesh Agarwal, Inderpaul Singh Sehgal, Kuruswamy Thurai Prasad, Valliappan Muth, Mandeep Garg, Amanjit Bal, Ashutosh N. Aggarwal, Digambar Behera
Abstract
BACKGROUND: Patients with idiopathic pulmonary fibrosis (IPF) often do not tolerate pirfenidone in the recommended dose of 2400 mg/day. The proportion of patients requiring dose reduction and its impact on survival in the real-world remain unclear. METHODS: Consecutive subjects with IPF were enrolled between March 2017 and June 2019. The maximum tolerated dose of pirfenidone (primary outcome) and adverse drug reactions (ADRs) were recorded. A post hoc logistic regression analysis was performed to evaluate the predictors of drug discontinuation due to ADRs. We also compared survival between the full-dose (2400 mg/day), reduced-dose (< 2400 mg/day), and the no-pirfenidone groups, with age and percentage of the predicted forced vital capacity (%pred FVC) as covariates. RESULTS: was the only predictor of drug discontinuation due to ADRs. Among subjects newly initiated on treatment during the study period (n = 80), survival was longer (hazard ratio [interquartile range], 0.19 [0.04-0.96]; p = 0.045) in the full-dose but not the reduced-dose group (p = 0.08) compared with the no-pirfenidone group, after adjusting for covariates. CONCLUSION: .