Effect of recombinant Human Pentraxin 2 vs placebo on change in forced vital capacity in patients with idiopathic pulmonary fibrosis: a randomized clinical trial
<h3>Importance</h3><p>Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease with poor prognosis. Approved therapies do not halt disease progression.</p><h3>Objective</h3><p>To determine the effect of recombinant human pentraxin 2 vs plac...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
June 12, 2018
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| In: |
The journal of the American Medical Association
Year: 2018, Volume: 319, Issue: 22, Pages: 2299-2307 |
| ISSN: | 1538-3598 |
| DOI: | 10.1001/jama.2018.6129 |
| Online Access: | Verlag, Volltext: https://doi.org/10.1001/jama.2018.6129 Verlag: https://jamanetwork.com/journals/jama/fullarticle/2681945 
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| Author Notes: | Ganesh Raghu, Bernt van den Blink, Mark J. Hamblin, A. Whitney Brown, Jeffrey A. Golden, Lawrence A. Ho, Marlies S. Wijsenbeek, Martina Vasakova, Alberto Pesci, Danielle E. Antin-Ozerkis, Keith C. Meyer, Michael Kreuter, Hugues Santin-Janin, Geert-Jan Mulder, Brian Bartholmai, Renu Gupta, Luca Richeldi |
| Summary: | <h3>Importance</h3><p>Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease with poor prognosis. Approved therapies do not halt disease progression.</p><h3>Objective</h3><p>To determine the effect of recombinant human pentraxin 2 vs placebo on change from baseline to week 28 in mean forced vital capacity (FVC) percentage of predicted value.</p><h3>Design, Setting, and Participants</h3><p>Phase 2, randomized, double-blind, placebo-controlled trial conducted at 18 sites in 7 countries of eligible patients with IPF (N = 117; aged 40-80 years; FVC ≥50% and ≤90% predicted; ratio of forced expiratory volume in the first second/FVC >0.70; diffusing capacity for carbon monoxide [Dlco] ≥25% and ≤90% predicted; and distance of ≥150 m on the 6-minute walk test). Study period was August 2015-May 2017.</p><h3>Interventions</h3><p>Patients were randomized to receive either recombinant human pentraxin 2 (10 mg/kg intravenous every 4 weeks, n = 77) or placebo (n = 39) for 24 weeks, and stratified by concurrent IPF treatment status.</p><h3>Main Outcomes and Measures</h3> |
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| Item Description: | Gesehen am 22.05.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1538-3598 |
| DOI: | 10.1001/jama.2018.6129 |