Reduction in Non-Elective Respiratory-Related Hospitalizations in Patients Treated With Pirfenidone: Pooled Analyses from Three Phase 3 Trials of Pirfenidone in Idiopathic Pulmonary Fibrosis

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Rationale: Patients with idiopathic pulmonary fibrosis (IPF) are frequently hospitalized for a variety of reasons. Respiratory-related hospitalizations may occur because of acute exacerbations of IPF, respiratory tract infections, respiratory failure and other causes. Regardless of cause, respiratory-related hospitalizations have been linked to poor outcomes in patients with IPF. We describe the proportion of patients from the three Phase 3 pirfenidone IPF trials with at least one non-elective hospitalization (all-cause, respiratory- related and non-respiratory-related) over 12 months. Methods: In three Phase 3 randomized, placebo-controlled studies of pirfenidone for IPF (CAPACITY I/II and ASCEND), patients were randomized to pirfenidone (2403 mg/day) or placebo. In the two CAPACITY studies, respiratory-related hospitalizations were a pre-specified endpoint. In ASCEND, hospitalizations were reported as adverse events (AEs), and retrospectively categorized as respiratory-related or non-respiratory by case review. The pooled rates of patients experiencing ≥1 non-elective hospitalizations (all-cause, respiratory-related and non-respiratory-related) for pirfenidone and placebo patients over 12 months are summarized. Rate of death post-hospitalization was also reported. Results: A total of 1,247 patients (692 CAPACITY and 555 ASCEND) were included (Table 1). In pooled analyses, the proportion of patients experiencing ≥1 all-cause hospitalizations over 12 months was no different between pirfenidone and placebo-treated patients. The proportion of patients experiencing ≥1 respiratory-related hospitalizations was 12% in the placebo group vs. 7% in the pirfenidone group (odds ratio 0.56; P = 0.004). Deaths after hospitalization were numerically reduced in the pirfenidone group, most substantially for respiratory-related hospitalizations. Tab. 1: Non-elective Hospitalizations in Patients Treated With Pirfenidone or Placebo over 12 Months. All-Cause Hospitalizations Respiratory-Related Hospitalizations Non-Respiratory Hospitalizations Hospitalizations Pirfenidone (N = 623) Placebo (N = 624) Pirfenidone (N = 623) Placebo (N = 624) Pirfenidone (N = 623) Placebo (N = 624) Events, n 140 147 57 86 83 61 Patients with ≥1 event n (%) 106 (17) 112 (18) 44 (7) 74 (12) 68 (11) 51 (8) Odds ratio (95% CI) 0.94 (0.70, 1.26) 0.56 (0.38, 0.84) 1.38 (0.94, 2.02) P -value 0.662 0.004 0.099 Died after hospitalization, n (%) 18 (17) 37 (33) 12 (27) 34 (46) 7 (10) 9 (18) Conclusion: Patients with IPF frequently require hospitalization for a variety of reasons. Pirfenidone may reduce the risk of non-elective respiratory-related hospitalizations over 12 months.

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