2023
Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease
Allanore Y, Khanna D, Smith V, Aringer M, Hoffmann-Vold A, Kuwana M, Merkel P, Stock C, Sambevski S, Denton C, Bergna M, Casado G, Walter P, Proudman S, Stevens W, Thakkar V, Troy L, Loeffler-Ragg J, Olschewski H, André B, Bondue B, Houssiau F, Smith V, Wuyts W, Azevedo V, Johnson S, Keystone E, Khalidi N, Levesque M, Rozas R, Orellana A, Huang C, Li J, Jiang Z, Liu Y, Xiao W, Xu J, Zeng X, Zheng Y, Zou H, Becvar R, Madsen H, Søndergaard K, Kilpeläinen M, Myllärniemi M, Agard C, Allanore Y, Bourdin A, Cottin V, Crestani B, Diot E, Dominique S, Hachulla E, Jouneau S, Leroy S, Nunes H, Prevot G, Wallaert B, Wemeau L, Aringer M, Bewig B, Blaas S, Distler J, Ehrchen J, Ewert R, Gläser S, Henes J, Hunzelmann N, König R, Kötter I, Kreuter M, Prasse A, Schulze-Koops H, Sfikakis P, Vlachoyiannopoulos P, Losonczy G, Behera D, Devi H, Kadel J, Kawedia M, Kumar D, Kumar U, Lokhande R, Malpani A, Mohan M, Nalawade A, Parakh U, Swarnakar R, Shobha V, Thangakunam B, Udwadia Z, Henry M, O'Reilly K, Balbir-Gurman A, Kramer M, Litinsky I, Rosner I, Cutolo M, Gabrielli A, Iaccarino L, Pesci A, Riccieri V, Vettori S, Funakubo Y, Inoue Y, Kawakami A, Kawaguchi Y, Kawamura T, Kondoh Y, Kuwana M, Nanki T, Nishioka Y, Nozawa K, Ogura T, Okamoto M, Sano H, Sasai R, Sasaki N, Suda T, Takahashi H, Takeuchi T, Makino S, Tanaka S, Yamasaki Y, Ch'ng S, Cheah C, Kan S, Mohamed R, Selman M, de Vries-Bouwstra J, van den Toorn L, Vonk M, Voskuyl A, Hoffmann-Vold A, Seip M, Dankiewicz-Fares I, Olesiejuk R, Pulka G, Szepietowski J, Alves J, Bernardes M, Cordeiro A, Costa J, Neves S, Salvador M, Sancho J, Delgado P, Barranco I, Martínez J, del Castillo A, Ovalles J, López-Longo F, Gallego A, Dapena M, Ivorra J, Ekwall A, Maurer B, Mihai C, Müller R, Mahakkanukrauh A, Nantiruj K, Siripaitoon B, Denton C, Herrick A, Madhok R, Maher T, West A, Antin-Ozerkis D, Bascom R, Criner G, Csuka M, D'Amico J, Ettinger N, Fischer A, Gerbino A, Gerke A, Glassberg M, Glazer C, Golden J, Gripaldo R, Gupta N, Hamblin M, Highland K, Ho L, Huggins J, Hummers L, Jones L, Kahaleh M, Khanna D, Kim H, Lancaster L, Luckhardt T, Mayes M, Ballesteros F, Mooney J, Mohabir P, Morrissey B, Moua T, Padilla M, Patel N, Perez R, Roman J, Rossman M, Russell T, Saketkoo L, Shah A, Shlobin O, Scholand M, Simms R, Spiera R, Steen V, Veeraraghavan S, Weigt S. Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease. Rheumatology 2023, 63: 639-647. PMID: 37294870, PMCID: PMC10907814, DOI: 10.1093/rheumatology/kead280.Peer-Reviewed Original ResearchLimited cutaneous systemic sclerosisInterstitial lung diseaseCutaneous systemic sclerosisSENSCIS trialEffect of nintedanibWeek 52Nintedanib groupPlacebo groupSystemic sclerosisLung diseaseProgressive fibrosing interstitial lung diseasesOpen-label nintedanibSSc-ILDLung functionPulmonary fibrosisNintedanibPatientsRate of declineFVCTrialsPlaceboSclerosisDiseaseGroupFibrosisZiritaxestat, 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
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