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P173 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
  1. B Ley1,
  2. JJ Swigris2,
  3. B Day3,
  4. J Stauffer3,
  5. W Chou3,
  6. K Raimundo3,
  7. H Collard1
  1. 1University of California–San Francisco, San Francisco, CA, USA
  2. 2National Jewish Health, Denver, CO, USA
  3. 3Genentech, Inc., South San Francisco, CA, USA

Abstract

Rationale Patients with idiopathic pulmonary fibrosis (IPF) are frequently hospitalised 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 hospitalisation (all-cause, respiratory-related and non-respiratory-related) over 12 months.

Methods In three Phase 3 randomised, placebo-controlled studies of pirfenidone for IPF (CAPACITY I/II and ASCEND), patients were randomised 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 categorised 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 summarised. Rate of death post-hospitalisation was also reported.

Results A total of 1,247 patients (692 CAPACITY and 555 ASCEND) were included (Table). 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 hospitalisation were numerically reduced in the pirfenidone group, most substantially for respiratory-related hospitalizations.

Conclusion Patients with IPF frequently require hospitalisation for a variety of reasons. Pirfenidone may reduce the risk of non-elective respiratory-related hospitalizations over 12 months.

Abstract P173 Table 1

Non-elective Hospitalizations in Patients Treated With Pirfenidone or Placebo over 12 Months

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