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S109 Effect of continued treatment with pirfenidone following a clinically meaningful decline in percent predicted forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF)
  1. PW Noble1,
  2. C Albera2,
  3. WZ Bradford3,
  4. U Costabel4,
  5. I Glaspole5,
  6. MK Glassberg6,
  7. L Lancaster7,
  8. DJ Lederer8,
  9. Z Lin3,
  10. CA Pereira9,
  11. JJ Swigris10,
  12. D Valeyre11,
  13. SD Nathan12
  1. 1Cedars Sinai Medical Center, Los Angeles, USA
  2. 2University of Turin, Turin, Italy
  3. 3InterMune Inc (A Wholly Owned Roche Subsidiary), Brisbane, USA
  4. 4Ruhrlandklinik, Essen, Germany
  5. 5Alfred Hospital, Melbourne, Australia
  6. 6University of Miami Miller School of Medicine, Miami, USA
  7. 7Vanderbilt University Medical Center, Nashville, USA
  8. 8Columbia University, New York, USA
  9. 9Paulista School of Medicine, Federal University, Sao Paulo, Brazil
  10. 10National Jewish Health, Denver, USA
  11. 11Avicenne Univsersity Hospital, Bobigny, France
  12. 12Inova Fairfax Hospital, Falls Church, USA

Abstract

Introduction and objectives The clinical course in patients with IPF is characterised by substantial inter- and intra-subject variability in the rates of disease progression, thereby confounding clinical assessments of therapeutic responses in individual patients. We pooled data from three Phase 3 trials to assess the potential benefit of continued treatment with pirfenidone in patients who experienced a ≥10% decline in percent predicted forced vital capacity (%FVC) during the first 6 months of treatment.

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

Results 34 (5.5%) and 68 (10.9%) patients in the pooled pirfenidone and placebo groups, respectively, experienced a ≥10% absolute decline in%FVC between baseline and month 6 (relative difference, 49.5%). Analysis of outcomes during the subsequent 6-month interval demonstrated that fewer patients in the pirfenidone group compared with placebo experienced a ≥10% decline in%FVC or death (pirfenidone, 2/34 [5.9%] vs. placebo, 19/68 [27.9%]). More patients in the pirfenidone group compared with placebo had no further decline in%FVC (20/34 [58.8%] vs. 26/68 [38.2%]; Table 1). Additionally, there were fewer deaths in the pirfenidone group (1/34 [2.9%]) compared with placebo (14/68 [20.6%]).

Abstract S109 Table 1

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

Conclusions Among patients who experienced a ≥10% decline in%FVC during the first 6 months of treatment, continued treatment with pirfenidone resulted in a lower risk of%FVC decline or death during the subsequent 6 months. These findings suggest a potential benefit to continued treatment with pirfenidone despite an initial decline in FVC.

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