IPF: pirfenidone linked to better outcomes in advanced disease

  • Respir Med

  • International Clinical Digest
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Takeaway

  • Patients with idiopathic pulmonary fibrosis (IPF) appear to benefit from pirfenidone (e.g., Esbriet) even amid advanced lung-function impairment.

Why this matters

  • Most enrollees in pivotal pirfenidone trials ASCEND and CAPACITY had less advanced lung-function impairment. 
  • Diagnosis of IPF is often delayed, with some patients experiencing advanced impairment at diagnosis.

Key results

  • Pirfenidone vs placebo groups (HRs; 95% CIs):
    • All-cause mortality (ACM): 0.28 (0.09-0.86; P=.0180);
      • Number needed to treat: 10.
    • ≥10% absolute %FVC decline or ACM: 0.40 (0.23-0.69; P=.0006).
    • Respiratory hospitalization (RH) or ACM: 0.45 (0.22-0.91; P=.0219).
    • ≥10% absolute %FVC decline or RH or ACM: 0.46 (0.28-0.76; P=.0018).
    • Pirfenidone group also had greater improvement from baseline in 6-minute walk distance and University of California-San Diego Shortness of Breath Questionnaire total score.
  • No new safety signal.

Study design

  • Post-hoc analysis of subgroup of ASCEND and CAPACITY trial participants (n=170). 
  • Participants had %FVC 
  • As with other participants, they were randomly assigned to pirfenidone 2403 mg/day vs placebo over 52 weeks.
  • Outcomes: all-cause mortality, composite outcomes.
  • Funding: Genentech, Inc.; F. Hoffmann-La Roche, Ltd.

Limitations

  • Small study population.

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