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Effect of Recombinant Human Pentraxin 2 vs Placebo on Change in Forced Vital Capacity in Patients With Idiopathic Pulmonary Fibrosis: A Randomized Clinical Trial
G. Raghu, B. van den Blink, MJ. Hamblin, AW. Brown, JA. Golden, LA. Ho, MS. Wijsenbeek, M. Vasakova, A. Pesci, DE. Antin-Ozerkis, KC. Meyer, M. Kreuter, H. Santin-Janin, GJ. Mulder, B. Bartholmai, R. Gupta, L. Richeldi,
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze II, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
NLK
Open Access Digital Library
od 1998-01-01 do Před 6 měsíci
Medline Complete (EBSCOhost)
od 1998-01-07 do Před 1 měsícem
PubMed
29800034
DOI
10.1001/jama.2018.6129
Knihovny.cz E-zdroje
- MeSH
- dvojitá slepá metoda MeSH
- homeodoménové proteiny škodlivé účinky farmakologie terapeutické užití MeSH
- idiopatická plicní fibróza farmakoterapie patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- metoda nejmenších čtverců MeSH
- rekombinantní proteiny škodlivé účinky farmakologie terapeutické užití MeSH
- senioři MeSH
- sérový amyloidový protein škodlivé účinky farmakologie terapeutické užití MeSH
- test chůzí MeSH
- vitální kapacita účinky léků MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Importance: Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease with poor prognosis. Approved therapies do not halt disease progression. Objective: 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. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: The primary end point was the least-squares mean change in FVC percentage of predicted value from baseline to week 28 (minimal clinically important difference, decline of 2%-6%). Secondary end points included mean change in lung volumes (total, normal, and interstitial lung abnormalities) on high-resolution computed tomography (HRCT) and 6-minute walk distance (minimal clinically important difference, 24-45 m). Results: Of 117 randomized patients, 116 received at least 1 dose of study drug (mean age, 68.6 years; 81.0% men; mean time since IPF diagnosis, 3.8 years), and 111 (95.7%) completed the study. The least-squares mean change in FVC percentage of predicted value from baseline to week 28 in patients treated with recombinant human pentraxin 2 was -2.5 vs -4.8 for those in the placebo group (difference, +2.3 [90% CI, 1.1 to 3.5]; P = .001). No significant treatment differences were observed in total lung volume (difference, 93.5 mL [90% CI, -27.7 to 214.7]), quantitative parenchymal features on HRCT (normal lung volume difference, -1.2% [90% CI, -4.4 to 1.9]; interstitial lung abnormalities difference, 1.1% [90% CI, -2.2 to 4.3]), or measurement of Dlco (difference, -0.4 [90% CI, -2.6 to 1.7]). The change in 6-minute walk distance was -0.5 m for patients treated with recombinant human pentraxin 2 vs -31.8 m for those in the placebo group (difference, +31.3 m [90% CI, 17.4 to 45.1]; P < .001). The most common adverse events in the recombinant human pentraxin 2 vs placebo group were cough (18% vs 5%), fatigue (17% vs 10%), and nasopharyngitis (16% vs 23%). Conclusions and Relevance: In this preliminary study, recombinant human pentraxin 2 vs placebo resulted in a slower decline in lung function over 28 weeks for patients with idiopathic pulmonary fibrosis. Further research should more fully assess efficacy and safety. Trial Registration: clinicaltrials.gov Identifier: NCT02550873.
1st Medical Faculty Charles University and Thomayer Hospital Prague Czech Republic
Department of Respiratory Medicine Erasmus University Medical Center Rotterdam the Netherlands
Inova Fairfax Hospital Falls Church Virginia
Mayo Clinic Rochester Minnesota
Promedior Inc Lexington Massachusetts
University of California San Francisco
University of Kansas Kansas City
University of Milano Bicocca Monza Italy
University of Washington Seattle
University of Wisconsin Madison
Citace poskytuje Crossref.org
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