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