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
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 declineFVCTrialsPlaceboSclerosisDiseaseGroupFibrosis
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
2018
Effect of Recombinant Human Pentraxin 2 vs Placebo on Change in Forced Vital Capacity in Patients With Idiopathic Pulmonary Fibrosis: A Randomized Clinical Trial
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, Santin-Janin H, Mulder GJ, Bartholmai B, Gupta R, Richeldi L. Effect of Recombinant Human Pentraxin 2 vs Placebo on Change in Forced Vital Capacity in Patients With Idiopathic Pulmonary Fibrosis: A Randomized Clinical Trial. JAMA 2018, 319: 2299-2307. PMID: 29800034, PMCID: PMC6134440, DOI: 10.1001/jama.2018.6129.Peer-Reviewed Original ResearchConceptsIdiopathic pulmonary fibrosisPentraxin 2Placebo groupPulmonary fibrosisWeek 28FVC percentageWalk distanceLung volumeProgressive fibrotic lung diseaseEnd pointVital capacity percentageCommon adverse eventsPlacebo-controlled trialPrimary end pointSecondary end pointsFibrotic lung diseaseForced Vital CapacityTotal lung volumeSignificant treatment differencesEligible patientsMeasurements of DLCOStudy drugAdverse eventsLung functionPoor prognosis