Real-world patterns of pirfenidone use and safety in patients with idiopathic pulmonary fibrosis in Canada: Data from INSPIRATION PLUS

RATIONALE: INSPIRATION PLUS (NCT02552849) was a prospective, observational registry of Canadian patients with idiopathic pulmonary fibrosis (IPF) treated with the oral antifibrotic agent pirfenidone. As an exploratory analysis of the registry, pirfenidone usage and safety were examined in patients with incident pirfenidone use. OBJECTIVE: To describe pirfenidone usage and tolerability in Canadian patients with IPF. METHODS: Patients with IPF who received pirfenidone were monitored prospectively beginning in April 2013. Planned outcomes included change in percent predicted forced vital capacity and the proportion of patients receiving a full pirfenidone dose (2403 mg/day). Data were collected during routine clinical visits. Pirfenidone usage and safety were analyzed in patients who initiated pirfenidone within 3 months of enrollment. RESULTS: A total of 297 patients enrolled; 125 patients with incident pirfenidone use; 98 patients with both baseline data and ≥ 1 follow-up visit comprised the analysis population. Median (range) duration of follow-up and number of follow-up visits were 10 (0.9–34.4) months and 3 (1–9) visits, respectively. Dose modifications occurred more frequently during the first 6 months of treatment than in the subsequent 6 months (23% vs 8% of patients). The incidence of adverse drug reactions was consistent with the known safety profile for pirfenidone; gastrointestinal-related events were most frequent. Increased age or a history of smoking was associated with an increased risk of discontinuing pirfenidone in the first 12 months of treatment. CONCLUSIONS: Canadian patients with IPF receiving pirfenidone had a similar safety profile compared with clinical trial data.