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
2020
Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial
Wells A, Flaherty K, Brown K, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts W, Stowasser S, Quaresma M, Goeldner R, Schlenker-Herceg R, Kolb M, investigators I, Abe S, Aburto M, Acosta O, Andrews C, Antin-Ozerkis D, Arce G, Arias M, Avdeev S, Barczyk A, Bascom R, Bazdyrev E, Beirne P, Belloli E, Bergna M, Bergot E, Bhatt N, Blaas S, Bondue B, Bonella F, Britt E, Buch K, Burk J, Cai H, Cantin A, Villegas D, Cazaux A, Cerri S, Chaaban S, Chaudhuri N, Cottin V, Crestani B, Criner G, Dahlqvist C, Danoff S, D'Amico J, Dilling D, Elias P, Ettinger N, Falk J, Pérez E, Gamez-Dubuis A, Giessel G, Gifford A, Glassberg M, Glazer C, Golden J, Carrera L, Guiot J, Hallowell R, Hayashi H, Hetzel J, Hirani N, Homik L, Hope-Gill B, Hotchkin D, Ichikado K, Ilkovich M, Inoue Y, Izumi S, Jassem E, Jones L, Jouneau S, Kaner R, Kang J, Kawamura T, Kessler R, Kim Y, Kishi K, Kitamura H, Kolb M, Kondoh Y, Kono C, Koschel D, Kreuter M, Kulkarni T, Kus J, Lebargy F, Jiménez A, Luo Q, Mageto Y, Maher T, Makino S, Marchand-Adam S, Marquette C, Martinez R, Martínez M, Rozas R, Miyazaki Y, Moiseev S, Molina-Molina M, Morrison L, Morrow L, Moua T, Nambiar A, Nishioka Y, Nunes H, Okamoto M, Oldham J, Otaola M, Padilla M, Park J, Patel N, Pesci A, Piotrowski W, Pitts L, Poonyagariyagorn H, Prasse A, Quadrelli S, Randerath W, Refini R, Reynaud-Gaubert M, Riviere F, Portal J, Rosas I, Rossman M, Safdar Z, Saito T, Sakamoto N, Fénero M, Sauleda J, Schmidt S, Scholand M, Schwartz M, Shapera S, Shlobin O, Sigal B, Orellana A, Skowasch D, Song J, Stieglitz S, Stone H, Strek M, Suda T, Sugiura H, Takahashi H, Takaya H, Takeuchi T, Thavarajah K, Tolle L, Tomassetti S, Tomii K, Valenzuela C, Vancheri C, Varone F, Veeraraghavan S, Villar A, Weigt S, Wemeau L, Wuyts W, Xu Z, Yakusevich V, Yamada Y, Yamauchi H, Ziora D. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. The Lancet Respiratory Medicine 2020, 8: 453-460. PMID: 32145830, DOI: 10.1016/s2213-2600(20)30036-9.Peer-Reviewed Original ResearchConceptsInterstitial lung diseaseIdiopathic pulmonary fibrosisIdiopathic non-specific interstitial pneumoniaAutoimmune interstitial lung diseaseUnclassifiable idiopathic interstitial pneumoniaNon-specific interstitial pneumoniaDose of nintedanibParallel-group trialIdiopathic interstitial pneumoniaEffect of nintedanibINBUILD trialInterstitial pneumoniaILD diagnosisHigh-resolution CTILD progressionFVC declineHypersensitivity pneumonitisProgressive fibrosing interstitial lung diseasesOverall populationInterstitial lung disease diagnosisChest imaging featuresProtocol-defined criteriaSafety of nintedanibChronic hypersensitivity pneumonitisDisease subgroup analyses
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