2024
Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial
Lancaster L, Cottin V, Ramaswamy M, Wuyts W, Jenkins R, Scholand M, Kreuter M, Valenzuela C, Ryerson C, Goldin J, Kim G, Jurek M, Decaris M, Clark A, Turner S, Barnes C, Achneck H, Cosgrove G, Lefebvre É, Flaherty K, Baratz D, Ettinger N, Layish D, Epstein M, Veeraraghavan S, Golden J, Ramaswamy M, Bascom R, Lancaster L, Scholand M, Case A, Zaman T, Betensley A, Antin-Ozerkis D, Montessi S, Fernandez E, Boente R, Sager J, Hunninghake G, Gibson K, Srour N, Dhar A, Wuyts W, Wielders P, Veltkamp M, Mostard R, Janssen R, Noordegraaf A, Glaspole I, Corte T, Beckert L, Brockway B, Veale A, Richeldi L, Harari S. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. American Journal Of Respiratory And Critical Care Medicine 2024, 210: 424-434. PMID: 38843105, PMCID: PMC11351797, DOI: 10.1164/rccm.202403-0636oc.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsQuantitative lung fibrosisIdiopathic pulmonary fibrosisPulmonary fibrosisRates of treatment-emergent adverse eventsIncidence of treatment-emergent adverse eventsClinical trialsTreatment of idiopathic pulmonary fibrosisExploratory efficacy endpointsImpaired quality of lifeFibrosis-related biomarkersDose cohortsBackground therapyPlacebo groupTolerability profileOnce-dailyEfficacy endpointPrimary endpointProgressive diseaseExertional dyspneaFVC declineFibrosis biomarkersAdverse eventsIPF therapyLung fibrosis
2023
Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis
Maher T, Ford P, Brown K, Costabel U, Cottin V, Danoff S, Groenveld I, Helmer E, Jenkins R, Milner J, Molenberghs G, Penninckx B, Randall M, Van Den Blink B, Fieuw A, Vandenrijn C, Rocak S, Seghers I, Shao L, Taneja A, Jentsch G, Watkins T, Wuyts W, Kreuter M, Verbruggen N, Prasad N, Wijsenbeek M, Chambers D, Chia M, Corte T, Glaspole I, Goh N, Holmes M, Malouf M, Thien F, Veitch E, Bondue B, Dahlqvist C, Froidure A, Slabbynck H, Wuyts W, Cartagena Salinas C, Feijoó Seoane R, Martínez V, Maturana R, Pavie Gallegos J, Rosenblut A, Silva R, Undurraga Pereira A, Doubkova M, Pauk N, Plackova M, Sterclova M, Bendstrup E, Shaker S, Titlestad I, Budweiser S, Grohé C, Koschel D, Kreuter M, Prasse A, Weber M, Wirtz H, Antoniou K, Daniil Z, Gaga M, Papakosta D, Izumi S, Okamoto M, Guerreros Benavides A, Iberico Barrera C, Peña Villalobos A, Campo Ezquibela A, Cifrian Martinez J, Fernandez Fabrellas E, Leiro V, Molina-Molina M, Nieto Barbero A, Sellares Torres J, Valenzuela C, Cheng S, Kuo P, Lee K, Sheu C, Gunen H, Mogulkoc Bishop N, Nayci S, Adamali H, Bianchi S, Chaudhuri N, Gibbons M, Hart S, Molyneaux P, Parfrey H, Saini G, Spencer L, Wiscombe S, Antin-Ozerkis D, Bascom R, Belperio J, Britt E, Fitzgerald J, Gomez Manjarres D, Gotfried M, Gupta N, Hotchkin D, Kaye M, Kreider M, Kureishy S, Lacamera P, Lancaster L, Lasky J, Lorch D, Mannem H, Morrow L, Moua T, Nambiar A, Raghu G, Raj R, Ramaswamy M, Reddy R, Russell T, Scholand M, Shea B, Suliman S, Swigris J, Thavarajah K, Tolle L, Tomic R, Warshoff N, Wesselius L, Yung G, Bergna M, De Salvo M, Fernandez Acquier M, Rodriguez A, Saez Scherbovsky P, Assayag D, Dhar A, Khalil N, Morisset J, Provencher S, Ryerson C, Shapera S, Bourdin A, Crestani B, Lebargy F, Reynaud-Gaubert M, Bonella F, Claussen M, Hammerl P, Karagiannidis C, Keller C, Randerath W, Stubbe B, Csánky E, Medgyasszay B, Muller V, Adir Y, Bar-Shai A, Berkman N, Fink G, Kramer M, Shitrit D, Bargagli E, Gasparini S, Harari S, Ravaglia C, Richeldi L, Vancheri C, Ebina M, Fujita M, Ichikado K, Inoue Y, Ishikawa N, Kato M, Kawamura T, Kondoh Y, Nishioka Y, Ogura T, Owan I, Saito T, Sakamoto N, Sakamoto K, Shirai M, Suda T, Tomii K, Chung M, Jeong S, Park C, Park J, Song J, Uh S, Chavarria Martinez U, Montano Gonzalez E, Ramirez A, Selman Lama M, Bresser P, Kramer H, Mostard R, Nossent E, Veltkamp M, Wijsenbeek M, Beckert L, Chang C, Veale A, Wilsher M, Bednarek M, Gasior G, Jasieniak-Pinis G, Jassem E, Mroz R, Piotrowski W, Abdullah I, Ambaram A, Irusen E, Van der Linden M, van Zyl-Smit R, Williams P, Allen J, Averill F, Belloli E, Brown A, Case A, Chaudhary S, Criner G, DeBoer K, Dilling D, Dorf J, Enelow R, Ettinger N, Feldman J, Gibson K, Golden J, Hamblin M, Hunninghake G, Karunakara R, Kim H, Luckhardt T, Menon P, Morrison L, Oldham J, Patel N, Schmidt S, Strek M, Summer R, Sussman R, Tita J, Veeraraghavan S, Whelan T, Zibrak J. Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis. JAMA 2023, 329: 1567-1578. PMID: 37159034, PMCID: PMC10170340, DOI: 10.1001/jama.2023.5355.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedClinical Trials, Phase III as TopicFemaleHumansIdiopathic Pulmonary FibrosisLungMaleMiddle AgedMulticenter Studies as TopicPhosphodiesterase InhibitorsQuality of LifeRandomized Controlled Trials as TopicRespiratory Physiological PhenomenaRespiratory System AgentsTreatment OutcomeConceptsIdiopathic pulmonary fibrosisKey secondary outcomesFVC declineSecondary outcomesPulmonary fibrosisCare treatmentSt George's Respiratory Questionnaire (SGRQ) total scoreRespiratory-related hospitalizationsSafety Monitoring CommitteeQuestionnaire total scoreNovel autotaxin inhibitorAnnual rateCause mortalityWeek 52Lung functionPrimary outcomeClinical outcomesVital capacityStudy terminationClinical trialsDisease progressionPlaceboMAIN OUTCOMEPatientsAutotaxin inhibitors
2020
Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial
Wells A, Flaherty K, Brown K, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts W, Stowasser S, Quaresma M, Goeldner R, Schlenker-Herceg R, Kolb M, investigators I, Abe S, Aburto M, Acosta O, Andrews C, Antin-Ozerkis D, Arce G, Arias M, Avdeev S, Barczyk A, Bascom R, Bazdyrev E, Beirne P, Belloli E, Bergna M, Bergot E, Bhatt N, Blaas S, Bondue B, Bonella F, Britt E, Buch K, Burk J, Cai H, Cantin A, Villegas D, Cazaux A, Cerri S, Chaaban S, Chaudhuri N, Cottin V, Crestani B, Criner G, Dahlqvist C, Danoff S, D'Amico J, Dilling D, Elias P, Ettinger N, Falk J, Pérez E, Gamez-Dubuis A, Giessel G, Gifford A, Glassberg M, Glazer C, Golden J, Carrera L, Guiot J, Hallowell R, Hayashi H, Hetzel J, Hirani N, Homik L, Hope-Gill B, Hotchkin D, Ichikado K, Ilkovich M, Inoue Y, Izumi S, Jassem E, Jones L, Jouneau S, Kaner R, Kang J, Kawamura T, Kessler R, Kim Y, Kishi K, Kitamura H, Kolb M, Kondoh Y, Kono C, Koschel D, Kreuter M, Kulkarni T, Kus J, Lebargy F, Jiménez A, Luo Q, Mageto Y, Maher T, Makino S, Marchand-Adam S, Marquette C, Martinez R, Martínez M, Rozas R, Miyazaki Y, Moiseev S, Molina-Molina M, Morrison L, Morrow L, Moua T, Nambiar A, Nishioka Y, Nunes H, Okamoto M, Oldham J, Otaola M, Padilla M, Park J, Patel N, Pesci A, Piotrowski W, Pitts L, Poonyagariyagorn H, Prasse A, Quadrelli S, Randerath W, Refini R, Reynaud-Gaubert M, Riviere F, Portal J, Rosas I, Rossman M, Safdar Z, Saito T, Sakamoto N, Fénero M, Sauleda J, Schmidt S, Scholand M, Schwartz M, Shapera S, Shlobin O, Sigal B, Orellana A, Skowasch D, Song J, Stieglitz S, Stone H, Strek M, Suda T, Sugiura H, Takahashi H, Takaya H, Takeuchi T, Thavarajah K, Tolle L, Tomassetti S, Tomii K, Valenzuela C, Vancheri C, Varone F, Veeraraghavan S, Villar A, Weigt S, Wemeau L, Wuyts W, Xu Z, Yakusevich V, Yamada Y, Yamauchi H, Ziora D. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. The Lancet Respiratory Medicine 2020, 8: 453-460. PMID: 32145830, DOI: 10.1016/s2213-2600(20)30036-9.Peer-Reviewed Original ResearchConceptsInterstitial lung diseaseIdiopathic pulmonary fibrosisIdiopathic non-specific interstitial pneumoniaAutoimmune interstitial lung diseaseUnclassifiable idiopathic interstitial pneumoniaNon-specific interstitial pneumoniaDose of nintedanibParallel-group trialIdiopathic interstitial pneumoniaEffect of nintedanibINBUILD trialInterstitial pneumoniaILD diagnosisHigh-resolution CTILD progressionFVC declineHypersensitivity pneumonitisProgressive fibrosing interstitial lung diseasesOverall populationInterstitial lung disease diagnosisChest imaging featuresProtocol-defined criteriaSafety of nintedanibChronic hypersensitivity pneumonitisDisease subgroup analyses