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, 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
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 analysisSerious 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
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 prognosisAn Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002)
Gotfried MH, Girod CE, Antin-Ozerkis D, Burgess T, Strombom I, Stauffer JL, Kirchgaessler KU, Padilla ML. An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002). Pulmonary Therapy 2018, 4: 59-71. PMID: 32026243, PMCID: PMC6967037, DOI: 10.1007/s41030-018-0053-y.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsIdiopathic pulmonary fibrosisPatient exposure yearsSerious treatment-emergent adverse eventsPulmonary fibrosisIPF progressionFrequent treatment-emergent adverse eventsUpper respiratory tract infectionSafety of pirfenidoneUse of pirfenidoneOpen-label studyPhase II studyGastroesophageal reflux diseaseNew safety signalsRespiratory tract infectionsOverall incidence rateLong-term safetyCumulative total exposureConcomitant prednisoneOpen labelReflux diseaseAdverse eventsII studyMaintenance doseMost patients