title: Efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis with more preserved lung function.
abstract: This post hoc analysis examined the differences in idiopathic pulmonary fibrosis disease progression and the effects of pirfenidone in patients stratified by more preserved versus less preserved baseline lung function status using forced vital capacity (FVC) or GAP (gender, age and physiology) index stage.Efficacy outcomes, i.e. FVC, 6-min walking distance (6MWD) and dyspnoea (University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ)), were analysed at 12 months in patients randomised to pirfenidone 2403 mg·day(-1) or placebo in the pooled phase 3 CAPACITY/ASCEND population (n=1247), with subgroups stratified by baseline FVC ≥80% versus <80% or GAP stage I versus II-III. Treatment-by-subgroup interaction was tested based on a rank ANCOVA model; factors in the model included study, region, treatment, subgroup and treatment-by-subgroup interaction term.Patients with both more preserved (FVC ≥80% or GAP stage I) and less preserved (FVC <80% or GAP stage II-III) lung function at baseline demonstrated clinically significant disease progression at 12 months in terms of categorical decline in FVC, 6MWD and UCSD SOBQ. The magnitude of pirfenidone treatment effect was comparable between subgroups, regardless of whether lung function was classified using FVC or GAP index stage.These findings support the initiation of treatment with pirfenidone, irrespective of stage of baseline lung function in this patient population.
authors.affiliation: Dept of Clinical and Biological Sciences, University of Turin, Turin, Italy carlo.albera@yahoo.it.
authors.forename: Carlo
authors.initials: C
authors.lastname: Albera
authors.affiliation: Ruhrlandklinik, University Hospital, University of Duisburg - Essen, Essen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Costabel
authors.affiliation: Clinical Science, InterMune Inc., Brisbane, CA, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Fagan
authors.affiliation: University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Marilyn K
authors.initials: MK
authors.lastname: Glassberg
authors.affiliation: Clinical Science, InterMune Inc., Brisbane, CA, USA.
authors.forename: Eduard
authors.initials: E
authors.lastname: Gorina
authors.affiliation: Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Lancaster
authors.affiliation: Depts of Medicine and Epidemiology, Columbia University Medical Center, New York, NY, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Lederer
authors.affiliation: Dept of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Nathan
authors.affiliation: Global Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Dominique
authors.initials: D
authors.lastname: Spirig
authors.affiliation: Interstitial Lung Disease Program, Division of Pulmonary, Critical Care, and Sleep Medicine, Dept of Medicine, National Jewish Health, Denver, CO, USA.
authors.forename: Jeff J
authors.initials: JJ
authors.lastname: Swigris
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D018450:Disease Progression; D004417:Dyspnea / Q000188:drug therapy; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011728:Pyridones / Q000627:therapeutic use*; D012129:Respiratory Function Tests; D011795:Surveys and Questionnaires; D013990:Tidal Volume; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011728:Pyridones; C093844:pirfenidone