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 fibrosisPamrevlumab for Idiopathic Pulmonary Fibrosis
Raghu G, Richeldi L, Fernández Pérez E, De Salvo M, Silva R, Song J, Ogura T, Xu Z, Belloli E, Zhang X, Seid L, Poole L, Bowler S, Corte T, Holmes M, Thien F, Wheatley J, Choi S, Chung M, Jeong S, Kim Y, Lee E, Lee H, Park C, Park J, Park J, Chi-Leung Lam D, Chan M, Lee K, Cao J, Chen J, Chen R, Dai H, Fu X, Liang Z, Luo Q, Shi G, Tong Z, Wang L, Yang S, Yu H, Zhang H, Zhang J, Zhao H, Wang W, Meng Y, Peng H, Ramaswamy M, Hamblin M, Fitzgerald J, Gupta N, Dematte J, Veeraraghavan S, O’Brien T, Luckhardt T, Lancaster L, Kokoszynska M, Ettinger N, Kaelin T, Siddiqi A, Collins B, Scholand M, Antin-Ozerkis D, Hyun K, Harden C, Averill F, Mallea J, Bascom R, Seeram V, Hajari Case A, Britt E, Shea B, Criner G, Gotfried M, Mageto Y, El Bayadi S, Reichner C, Mooney J, Hotchkin D, Abrencillo R, Boente R, Lee J, Betensley A, Jeganathan N, Walia R, Albertson T, Rosas I, Puppala D, Abraham L, Enelow R, Bhatt N, Bandyopadhyay D, Elias P, Bergna M, Garcia G, De Stefano G, Wehbe L, Chirino A, Rojas R, Otaola M, Miranda G, Florenzano M, Silva Orellana R, Glasinovich V, Shangina O, Nikishenkov A, Kuzubova N. Pamrevlumab for Idiopathic Pulmonary Fibrosis. JAMA 2024, 332: 380-389. PMID: 38762797, PMCID: PMC11304118, DOI: 10.1001/jama.2024.8693.Peer-Reviewed Original ResearchIdiopathic pulmonary fibrosisBaseline to weekPulmonary fibrosisAdverse eventsBetween-group differencesPrimary outcomePhase 3 randomized clinical trialSecondary outcomesTreatment-related adverse eventsProgression of idiopathic pulmonary fibrosisPhase 2 trialAssociated with adverse eventsRate of lung function declineSubstantial adverse eventsAbsolute changeStatistically significant between-group differencesPatient-reported symptomsLung function declineSignificant between-group differencesFollow-up encountersPatient-reported outcomesPlacebo groupAntifibrotic treatmentPamrevlumabClinical trials
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
2019
Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials
Wuyts W, Antin-Ozerkis D, Huggins JT, LaCamera PP, Spagnolo P, Vašáková M, Wijsenbeek MS, Polman B, Kirchgaessler KU, Scholand MB. Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials. Respiratory Medicine 2019, 150: 120-125. PMID: 30961937, DOI: 10.1016/j.rmed.2019.02.021.Peer-Reviewed Original ResearchConceptsSerious adverse eventsIdiopathic pulmonary fibrosisAdverse eventsPulmonary fibrosisClinical trialsCardiac disordersFatal interstitial lung diseaseInterstitial lung diseaseRespiratory failureCommon comorbiditiesPlacebo armLung functionFatal outcomeLung diseasePooled analysisMyocardial infarctionUnpredictable courseDisease progressionFatal infectionSafety dataPatientsPlaceboFibrosisInfectionTrials
2013
Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials
Saketkoo L, Mittoo S, Huscher D, Khanna D, Dellaripa P, Distler O, Flaherty K, Frankel S, Oddis C, Denton C, Fischer A, Kowal-Bielecka O, LeSage D, Merkel P, Phillips K, Pittrow D, Swigris J, Antoniou K, Baughman R, Castelino F, Christmann R, Christopher-Stine L, Collard H, Cottin V, Danoff S, Highland K, Hummers L, Shah A, Kim D, Lynch D, Miller F, Proudman S, Richeldi L, Ryu J, Sandorfi N, Sarver C, Wells A, Strand V, Matteson E, Brown K, Seibold J, Aggarwal* R, Ainslie G, Alkassab F, Allanore Y, Descartes P, Anderson M, Andonopoulos A, Antin-Ozerkis D, Arrobas A, Ascherman* D, Assassi S, Baron M, Bathon* J, Behr J, Beretta L, Bingham C, Binnie M, Birring S, Boin F, Bongartz* T, Bourdin A, Bouros D, Brasington R, Bresser P, Buch M, Burge P, Carmona L, Carreira P, Carvalho C, Catoggio L, Chan K, Chapman J, Chatterjee S, Chua* F, Chung L, Conron M, Corte T, Cosgrove G, Costabel U, Cox G, Crestani B, Crofford L, Csuka M, Curbelo P, László C, Daniil Z, D'Arsigny C, Davis G, de Andrade J, De Vuyst P, Dempsey O, Derk C, Distler J, Dixon* W, Downey G, Doyle M, Drent M, Durairaj L, Emery P, Espinoza L, Farge D, Fathi M, Fell C, Fessler B, Fitzgerald J, Fox G, Foeldvari I, Frech T, Freitas S, Furst* D, Gabrielli A, García-Vicuña R, Georgiev O, Gerbino A, Gillisen A, Gladman D, Glassberg M, Gochuico B, Gogali A, Goh* N, Goldberg A, Goldberg H, Gourley* M, Griffing L, Grutters J, Gunnarsson R, Hachulla E, Hall F, Harari S, Herrick A, Herzog E, Hesselstrand R, Hirani N, Hodgson U, Hollingsworth H, Homer R, Hoyles R, Hsu V, Hubbard R, Hunzelmann N, Isasi M, Isasi E, Jimenez J, Johnson S, Jones C, Kahaleh B, Kairalla R, Kalluri M, Kalra S, Kaner R, Kinder B, Klingsberg R, Kokosi M, Kolb M, Kur-Zalewska J, Kuwana* M, Lake F, Lally E, Lasky J, Laurindo I, Able L, Lee P, Leonard C, Lien D, Limper A, Liossis S, Lohr K, Loyd J, Lundberg* I, Mageto Y, Maher T, Mahmud T, Manganas H, Marie I, Marras T, Martinez J, Martinez F, Mathieu A, Matucci-Cerinic* M, Mayes* M, McKown K, Medsger T, Meehan R, Cristina M, Meyer K, Millar A, Moğulkoç N, Molitor J, Morais A, Mouthon P, Müller V, Müller-Quernheim J, Nadashkevich O, Nador R, Nash P, Nathan S, Navarro C, Neves S, Noth I, Nunes H, Olson A, Opitz C, Padilla M, Pappas D, Parfrey H, Pego-Reigosa J, Pereira C, Perez R, Pope* J, Porter J, Renzoni E, Riemekasten G, Riley D, Rischmueller M, Rodriguez-Reyna T, Rojas-Serrano, Romam J, Rosen G, Rossman M, Rothfield N, Sahn S, Sanduzzi A, Scholand M, Selman M, Senécal J, Seo P, Silver* R, Solomon J, Steen* V, Stevens W, Strange C, Sussman R, Sutton E, Sweiss N, Tornling G, Tzelepis G, Undurraga A, Vacca A, Vancheri C, Varga J, Veale D, Volkov S, Walker U, Wencel M, Wesselius L, Wickremasinghe M, Wilcox P, Wilsher M, Wollheim F, Wuyts W, Yung G, Zanon P, Zappala C, Groshong S, Leslie K, Myers J, Padera R, Desai S, Goldin J, Kazerooni E, Klein J, Lynch D, Keen K. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials. Thorax 2013, 69: 436. PMID: 24368713, PMCID: PMC3995282, DOI: 10.1136/thoraxjnl-2013-204202.Peer-Reviewed Original ResearchConceptsIdiopathic pulmonary fibrosisConnective tissue diseaseInterstitial lung diseaseCTD-ILDPulmonary fibrosisTissue diseaseLung diseaseClinical trialsOutcome measuresRelated interstitial lung diseaseNominal group panelHealth-related qualityPatient focus groupsMulticentre clinical trialAppropriate outcome measuresClinical trial designILD expertsDisease activityMulticentre RCTsTreatment responseLung physiologyTrial designConsensus methodologyIdentification of outcomesLung imaging