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
2022
Long-term evaluation of the safety and efficacy of recombinant human pentraxin-2 (rhPTX-2) in patients with idiopathic pulmonary fibrosis (IPF): an open-label extension study
Raghu G, Hamblin MJ, Brown AW, Golden JA, Ho LA, Wijsenbeek MS, Vasakova M, Pesci A, Antin-Ozerkis DE, Meyer KC, Kreuter M, Burgess T, Kamath N, Donaldson F, Richeldi L. Long-term evaluation of the safety and efficacy of recombinant human pentraxin-2 (rhPTX-2) in patients with idiopathic pulmonary fibrosis (IPF): an open-label extension study. Respiratory Research 2022, 23: 129. PMID: 35597980, PMCID: PMC9123757, DOI: 10.1186/s12931-022-02047-0.Peer-Reviewed Original ResearchConceptsOpen-label extensionIdiopathic pulmonary fibrosisWeek 128PRM-151Serious TEAEsPulmonary fibrosisPentraxin 2Efficacy dataRandomized periodTreatment-emergent adverse event profilesOpen-label extension studyAcute respiratory failureAdverse event profileNew safety signalsPatient-reported outcomesLimited efficacy dataLong-term safetyEudraCT 2014Lung transplantationRespiratory failureWalk distanceLong-term evaluationEvent profileVital capacityIntravenous infusion
2019
Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study
Raghu G, van den Blink B, Hamblin MJ, Brown AW, Golden JA, Ho LA, Wijsenbeek MS, Vasakova M, Pesci A, Antin-Ozerkis DE, Meyer KC, Kreuter M, Moran D, Santin-Janin H, Aubin F, Mulder GJ, Gupta R, Richeldi L. Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study. The Lancet Respiratory Medicine 2019, 7: 657-664. PMID: 31122893, DOI: 10.1016/s2213-2600(19)30172-9.Peer-Reviewed Original ResearchConceptsOpen-label extension studyIdiopathic pulmonary fibrosisPRM-151Adverse eventsLong-term treatmentWalking distanceExtension studyIPF exacerbationsWeek 52Week 76Pulmonary fibrosisIPF progressionDouble-blind treatment periodLife-threatening adverse eventsDouble-blind periodExploratory efficacy analysesSerious adverse eventsSevere adverse eventsMin intravenous infusionLong-term safetyRandom intercept mixed modelChest painPlacebo groupMore patientsEfficacy analysis