Effect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosis

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dc.citation.issue5
dc.citation.volume71
dc.contributor.authorNathan, Steven D.
dc.contributor.authorAlbera, Carlo
dc.contributor.authorBradford, Williamson Z.
dc.contributor.authorCostabel, Ulrich
dc.contributor.authordu Bois, Roland M.
dc.contributor.authorFagan, Elizabeth A.
dc.contributor.authorFishman, Robert S.
dc.contributor.authorGlaspole, Ian
dc.contributor.authorGlassberg, Marilyn K.
dc.contributor.authorGlasscock, Kenneth F.
dc.contributor.authorKing, Talmadge E., Jr.
dc.contributor.authorLancaster, Lisa
dc.contributor.authorLederer, David J.
dc.contributor.authorLin, Zhengning
dc.contributor.authorPereira, Carlos A. [UNIFESP]
dc.contributor.authorSwigris, Jeffrey J.
dc.contributor.authorValeyre, Dominique
dc.contributor.authorNoble, Paul W.
dc.contributor.authorWells, Athol U.
dc.coverageLondon
dc.date.accessioned2020-07-22T13:23:02Z
dc.date.available2020-07-22T13:23:02Z
dc.date.issued2016
dc.description.abstractBackground The assessment of treatment response in idiopathic pulmonary fibrosis (IPF) is complicated by the variable clinical course. We examined the variability in the rate of disease progression and evaluated the effect of continued treatment with pirfenidone in patients who experienced meaningful progression during treatment. Methods The source population included patients enrolled in the ASCEND and CAPACITY trials (N=1247). Pearson's correlation coefficients were used to characterise the relationship between changes in FVC during consecutive 6-month intervals in the placebo population. Outcomes following a >= 10% decline in FVC were evaluated by comparing the proportion of patients in the pirfenidone and placebo groups who experienced a >= 10% decline in FVC or death during the subsequent 6 months. Results A weak negative correlation was observed between FVC changes during consecutive intervals in the placebo population (coefficient, -0.146, p<0.001), indicating substantial variability. Thirty-four (5.5%) and 68 (10.9%) patients in the pirfenidone and placebo groups, respectively, experienced a >= 10% decline in FVC by month 6. During the subsequent 6 months, fewer patients in the pirfenidone group compared with placebo experienced a >= 10% decline in FVC or death (5.9% vs 27.9%en
dc.description.abstractrelative difference, 78.9%). There was one (2.9%) death in the pirfenidone group and 14 (20.6%) deaths in the placebo group (relative difference, 85.7%). Conclusions Longitudinal FVC data from patients with IPF showed substantial intrasubject variability, underscoring the inability to reliably assess therapeutic response using serial FVC trends. In patients who progressed during treatment, continued treatment with pirfenidone resulted in a lower risk of subsequent FVC decline or death.en
dc.description.affiliationInova Fairfax Hosp, Heart & Lung Transplant Ctr, Falls Church, VA 22042 USA
dc.description.affiliationUniv Turin, Dept Clin & Biol Sci, Turin, Italy
dc.description.affiliationInterMune Inc, Brisbane, CA USA
dc.description.affiliationRuhrlandklin, Dept Pneumol Allergy, Essen, Germany
dc.description.affiliationUniv London Imperial Coll Sci Technol & Med, London, England
dc.description.affiliationAlfred Hosp, Melbourne, Australia
dc.description.affiliationMonash Univ, Melbourne, Australia
dc.description.affiliationUniv Miami, Miller Sch Med, Miami, FL 33136 USA
dc.description.affiliationUniv Calif San Francisco, San Francisco, CA 94143 USA
dc.description.affiliationVanderbilt Univ, Med Ctr, Nashville, TN USA
dc.description.affiliationColumbia Univ, Med Ctr, New York, NY USA
dc.description.affiliationUniv Fed Sao Paulo, Paulista Sch Med, Sao Paulo, Brazil
dc.description.affiliationNatl Jewish Hlth, Interstitial Lung Dis Program, Denver, CO USA
dc.description.affiliationAvicenne Univ Hosp, AP HP, Bobigny, France
dc.description.affiliationCedars Sinai Med Ctr, Los Angeles, CA 90048 USA
dc.description.affiliationRoyal Brompton Hosp, London SW3 6LY, England
dc.description.affiliationUnifespUniv Fed Sao Paulo, Paulista Sch Med, Sao Paulo, Brazil|
dc.description.sourceWeb of Science
dc.description.sponsorshipInterMune Inc. (Brisbane, California, USA)
dc.format.extent429-435
dc.identifierhttp://dx.doi.org/10.1136/thoraxjnl-2015-207011
dc.identifier.citationThorax. London, v. 71, n. 5, p. 429-435, 2016.
dc.identifier.doi10.1136/thoraxjnl-2015-207011
dc.identifier.fileWOS000375075000009.pdf
dc.identifier.issn0040-6376
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/55994
dc.identifier.wosWOS:000375075000009
dc.language.isoeng
dc.publisherBmj Publishing Group
dc.relation.ispartofThorax
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleEffect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosisen
dc.typeinfo:eu-repo/semantics/article
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