Risk factors associated with discontinuation of pirfenidone due to an adverse drug reaction (ADR)# in the overall population

Predictor of early discontinuationComparisonOR (95% CI)p-value
At 6 months
 AgeContinuous1.06 (1.03–1.08)<0.0001
 Female sexYes versus no1.59 (1.06–2.33)0.0228
 Steroid use prior to studyYes versus no1.64 (1.10–2.43)0.0148
At 12 months
 AgeContinuous1.06 (1.04–1.08)<0.0001
 Female sexYes versus no1.52 (1.04–2.17)0.0288
 Steroid use prior to studyYes versus no1.48 (1.02–2.17)0.0406
 Underlying pulmonary disease+Yes versus no0.72 (0.50–1.03)0.0748
During entire study
 AgeContinuous1.03 (1.01–1.05)0.0009
 Female sexYes versus no1.54 (1.08–2.22)0.0193
 BMIContinuous0.96 (0.92–0.99)0.0127
 UK patientsYes versus no1.65 (1.14–2.39)0.0081
 Current alcohol useYes versus no0.73 (0.53–1.01)0.0555
 Years since IPF diagnosisContinuous1.04 (0.99–1.09)0.1245
 Ex-/current smokerYes versus no1.30 (0.94–1.79)0.1111

BMI: body mass index; IPF: idiopathic pulmonary fibrosis; FVC: forced vital capacity. #: an ADR was defined as any safety event with a possible causal relationship to pirfenidone (the treating physician (investigator) made a clinical judgement to decide if the ADR was related to pirfenidone); : following analysis of early discontinuation due to an ADR, the following baseline variables were included in the stepwise logistic regression model-building process: age, sex, BMI, smoking/alcohol status, steroid/azathioprine exposure, UK patient, alanine aminotransferase, FVC, years since IPF diagnosis, FVC % pred <50% and other pulmonary/hepatic/cardiovascular disease; +: other than IPF.