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P174 Effect of continued treatment with pirfenidone following a ≥10% relative decline in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF)
  1. AU Wells1,
  2. C Albera2,
  3. U Costabel3,
  4. I Glaspole4,
  5. MK Glassberg5,
  6. L Lancaster6,
  7. DJ Lederer7,
  8. CA Pereira8,
  9. JJ Swigris9,
  10. B-M Day10,
  11. W Chou10,
  12. SD Nathan11
  1. 1Royal Brompton Hospital, London, UK
  2. 2University of Turin, Turin, Italy
  3. 3Ruhrlandkinik, Essen, Germany
  4. 4Alfred Hospital, Melbourne, Australia
  5. 5University of Miami Miller School of Medicine, Miami, USA
  6. 6Vanderbilt University Medical Centre, Nashville, USA
  7. 7Columbia University Medical Centre, New York, USA
  8. 8Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil
  9. 9National Jewish Health, Denver, USA
  10. 10Genentech Inc, South San Francisco, USA
  11. 11Inova Fairfax Hospital, Falls Church, USA

Abstract

Background The variability in disease progression in patients with IPF complicates the assessment of treatment response. Previously a pooled analysis of three Phase 3 trials showed that patients who experienced a ≥10% absolute decline in %FVC during the first 6 months of treatment derived a clinical benefit with continued pirfenidone treatment in the subsequent 6 months [Nathan et al. ATS 2015]. To further explore the potential benefit of continued pirfenidone treatment in patients who initially experienced more modest declines, we assessed subsequent outcomes after a ≥ 10% relative decline in %FVC during the first 6 months of treatment.

Methods Source data included all patients randomised to receive pirfenidone 2403 mg/d or placebo in the ASCEND or CAPACITY trials (N = 1247). All patients with a ≥10% relative decline in%FVC were selected by the 6-month study visit. The proportion of patients in the pirfenidone and placebo groups who experienced any of the following during the subsequent 6-month interval were compared: (1) ≥10% relative decline in%FVC or death; (2) death; or (3) no further decline in %FVC.

Results Of the pooled patients that experienced an initial ≥10% relative decline in %FVC, 80 and 140 patients received pirfenidone and placebo, respectively. In the subsequent 6 months, 17 (21.3%) and 50 (35.7%) patients, respectively, experienced a ≥ 10% relative decline in %FVC or death. In addition, more patients in the pirfenidone group had no further decline in %FVC and fewer patients died compared with placebo during the subsequent 6-month interval (Table 1).

Conclusions In patients who experienced a ≥10% relative decline in %FVC during the first 6 months of treatment, continued treatment with pirfenidone appeared to lower the risk of %FVC decline or death during the subsequent 6 months, similar to previous results observed with a ≥10% absolute %FVC cut-off. Using relative change to calculate a ≥10% initial FVC decline identified more than twice as many patients compared to using absolute change. These findings suggest a potential benefit to continued treatment with pirfenidone despite an initial clinically meaningful decline in FVC ≥10% regardless of calculation method.

Abstract P174 Table 1

Outcomes during the 6-month period following an initial ≥10% relative decline in %FVC during the first 6 months of treatment

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