Pre-existing anti-PEG antibodies are associated with severe immediate allergic reactions to pegnivacogin, a PEGylated aptamer - 18/04/17
Doi : 10.1016/j.jaci.2016.04.058
Thomas J. Povsic, MD, PhD a 
, Monica G. Lawrence, MD b, A. Michael Lincoff, MD c, Roxana Mehran, MD d, Christopher P. Rusconi, PhD e, Steven L. Zelenkofske, DO e, Zhen Huang, MS a, Jeffrey Sailstad, BS f, Paul W. Armstrong, MD g, P. Gabriel Steg, MD h, i, j, Christoph Bode, MD k, Richard C. Becker, MD l, John H. Alexander, MD, MHS a, N. Franklin Adkinson, MD m, Arnold I. Levinson, MD n
on behalf of the
, Monica G. Lawrence, MD b, A. Michael Lincoff, MD c, Roxana Mehran, MD d, Christopher P. Rusconi, PhD e, Steven L. Zelenkofske, DO e, Zhen Huang, MS a, Jeffrey Sailstad, BS f, Paul W. Armstrong, MD g, P. Gabriel Steg, MD h, i, j, Christoph Bode, MD k, Richard C. Becker, MD l, John H. Alexander, MD, MHS a, N. Franklin Adkinson, MD m, Arnold I. Levinson, MD non behalf of the
REGULATE-PCI Investigators
a Duke Clinical Research Institute, Duke Medicine, Durham, NC
b University of Virginia, Charlottesville, Va
c Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, Ohio
d Mount Sinai School of Medicine, New York, NY
e Regado Biosciences, Basking Ridge, NJ
f Sailstad and Associates, Inc, Durham, NC
g Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada
h Université Paris-Diderot, Sorbonne Paris Cité, Paris, France
i Assistance Publique-Hôpitaux de Paris, Paris, France
j NHLI, Royal Brompton Hospital, Imperial College, London, United Kingdom
k University of Freiburg, Freiburg, Germany
l University of Cincinnati College of Medicine, Cincinnati, Ohio
m Johns Hopkins Asthma and Allergy Center, Baltimore, Md
n Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa
| The REGULATE-PCI trial and this analysis were funded by Regado Biosciences Inc. The sponsor of the trial, Regado Biosciences, participated in the design of the trial and the analysis plan for biospecimens collected in the trial, in collaboration with the investigators of the trial. The sponsor selected the core laboratories for the analysis, but did not perform the analyses or analyze the data. The corresponding author drafted this manuscript and made all revisions on the basis of input from the coauthors, including those employed by the sponsor. The sponsor had no role in the decision to submit the manuscript for publication. |
|
| Disclosure of potential conflict of interest: T. J. Povsic has received a grant from Regado Biosciences. M. G. Lawrence has received consulting and/or advisory board fees from Baxter Healthcare, has received fees for participation in review activities from Regado Biosciences/Faculty Connections, and has consultant arrangements with Merck/Faculty Connections. A. M. Lincoff has received a grant and travel support from Regado Biosciences; has received grants from Roche/Genentech, AstraZeneca, CSL, Eli Lilly, Pfizer, and Takeda; has received personal fees from CSL, Semonix, Amgen, Sarepta, and Abbott; and has received travel reimbursement from Eli Lilly, Pfizer, Takeda, Amgen, Sarepta, and Abbott. R. Mehran has received consulting and/or advisory board fees from Regado Biosciences, Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, CSL-Behring, Janssen Pharmaceuticals, Maya Medical, Merck, and Sanofi-Aventis; grants from Eli Lilly/Daiichi Sankyo, AstraZeneca, The Medicines Company, Bristol-Myers Squibb/Sanofi-Aventis, and OrbusNeich; and has received consulting fees from Janssen Pharmaceuticals, Medscape, Osprey Medical Inc, and Watermark Research Partners. C. P. Rusconi has consultant arrangements with and is employed by Regado Biosciences, is current consultant for Tobira Therapeutics, is inventor on multiple pending and issued patents covering REG1 and its uses, has patents related to the composition of the subject of this article (no compensation received), and has stock options as an employee of Regado Biosciences. S. L. Zelenkofske is a former employee of Regado Biosciences and has a patent pending for anti-PEG antibodies. J. Sailstad has received consulting fees from Regado Biosciences. P. W. Armstrong has received research support from Boehringer-Ingelheim, AstraZeneca, GlaxoSmithKline, and Regado Biosciences and consulting and/or advisory board fees and/or honoraria from Boehringer-Ingelheim, Eli Lilly, Roche, Bayer, AstraZeneca, GlaxoSmithKline, and Regado Biosciences. P. G. Steg has received consulting fees and travel support from Regado Biosciences; has consultant arrangements with Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers-Squibb, CSL-Behring, Daiichi Sankyo, GlaxoSmithKline, Janssen, Lilly, MerckSharpeDohme, Novartis, Pfizer, Regeneron, Roche, Sanofi, Servier, Otsuka, Medtronic, Vivus, Janssen, Orexigen, and The Medicines Company; has received grants from Merck, Sanofi, and Servier; and has received payment for lectures from AstraZeneca, Amgen, and Merck. C. Bode has received a grant and consulting fees from Regado Biosciences; has received payment for lectures from Bayer, BMS, and Daiichi Sankyo; and has received consulting fees and/or honoraria from AstraZeneca, Bayer, Daiichi Sankyo, and Merck. R. C. Becker has received a grant from Duke University; has consultant arrangements with Janssen, AstraZeneca, and Portola; has received consulting fees and/or honoraria from Regado Biosciences; and has received research support from the National Heart, Lung, and Blood Institute. J. H. Alexander has consultant arrangements with Bristol-Myers-Squibb, CSL-Behring, Daiichi Sankyo, GlaxoSmithKline, Janssen, Pfizer, Sohmalution, and Xoma; has received consulting fees from the American College of Cardiology, Portola, and the VA Cooperative Studies Program; has received a grant from Regado Biosciences, Boehringer-Ingelheim, Bristol-Myers-Squibb, CSL-Behring, Pfizer, Sanofi, Tenax, the National Institutes of Health, Tenex Therapeutics, and Vivus Pharmaceuticals; Duke University owns a small amount of equity in Regado Biosciences. The amount and terms of this equity are unknown to anyone involved in this project. N. F. Adkinson has received fees for Data Safety Monitoring Board service from Duke University and for participation in review activities from Duke Clinical Trials. A. I. Levinson has received consulting fees from Regado Biosciences, Stallergenes, Endo Pharmaceuticals, and the US Department of Health and Human Services and has consultant arrangements with Janssen and EISAI Pharmaceuticals. The rest of the authors declare that they have no relevant conflicts of interest. |
© 2016
Publié par Elsevier Masson SAS.
Vol 138 - N° 6
P. 1712-1715 - décembre 2016 Retour au numéro
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