The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions - 03/02/22
Doi : 10.1016/j.jaci.2021.10.035
Steve N. Georas, MD a, ⁎ 
, Rosalind J. Wright, MD, MPH b, Anastasia Ivanova, PhD c, Elliot Israel, MD d, Lisa M. LaVange, PhD c, Praveen Akuthota, MD e, Tara F. Carr, MD f, Loren C. Denlinger, MD, PhD g, Merritt L. Fajt, MD h, Rajesh Kumar, MD, MS i, Wanda K. O’Neal, PhD, MD j, Wanda Phipatanakul, MD, MS k, Stanley J. Szefler, MD l, m, Mark A. Aronica, MD n, Leonard B. Bacharier, MD o, Allison J. Burbank, MD j, Mario Castro, MD, MPH p, Laura Crotty Alexander, MD e, Julie Bamdad, MSE q, Juan Carlos Cardet, MD r, Suzy A.A. Comhair, PhD n, Ronina A. Covar, MD s, Emily A. DiMango, MD t, Kim Erwin, MDes u, Serpil C. Erzurum, MD n, John V. Fahy, MD, MSc v, Jonathan M. Gaffin, MD, MMSc k, Benjamin Gaston, MD w, Lynn B. Gerald, PhD, MSPH f, Eric A. Hoffman, PhD x, Fernando Holguin, MD, MPH m, Daniel J. Jackson, MD g, John James, MA c, Nizar N. Jarjour, MD g, Nicholas J. Kenyon, MD, MAS y, Sumita Khatri, MD, MS z, John P. Kirwan, MSc, PhD, FACSM aa, Monica Kraft, MD f, Jerry A. Krishnan, MD, PhD ab, Andrew H. Liu, MD l, m, Mark C. Liu, MD ac, M. Alison Marquis, MStat c, Fernando Martinez, MD f, Jacob Mey, PhD, RD aa, Wendy C. Moore, MD ad, James N. Moy, MD ae, Victor E. Ortega, MD ad, David B. Peden, MD, MS j, Emily Pennington, MD af, Michael C. Peters, MD v, Kristie Ross, MD af, ai, Maria Sanchez, BS c, Lewis J. Smith, MD ag, Ronald L. Sorkness, PhD g, Michael E. Wechsler, MD l, m, Sally E. Wenzel, MD h, Steven R. White, MD ah, Joe Zein, MD, MBA z, Amir A. Zeki, MD, MAS y, Patricia Noel, PhD q
the
, Rosalind J. Wright, MD, MPH b, Anastasia Ivanova, PhD c, Elliot Israel, MD d, Lisa M. LaVange, PhD c, Praveen Akuthota, MD e, Tara F. Carr, MD f, Loren C. Denlinger, MD, PhD g, Merritt L. Fajt, MD h, Rajesh Kumar, MD, MS i, Wanda K. O’Neal, PhD, MD j, Wanda Phipatanakul, MD, MS k, Stanley J. Szefler, MD l, m, Mark A. Aronica, MD n, Leonard B. Bacharier, MD o, Allison J. Burbank, MD j, Mario Castro, MD, MPH p, Laura Crotty Alexander, MD e, Julie Bamdad, MSE q, Juan Carlos Cardet, MD r, Suzy A.A. Comhair, PhD n, Ronina A. Covar, MD s, Emily A. DiMango, MD t, Kim Erwin, MDes u, Serpil C. Erzurum, MD n, John V. Fahy, MD, MSc v, Jonathan M. Gaffin, MD, MMSc k, Benjamin Gaston, MD w, Lynn B. Gerald, PhD, MSPH f, Eric A. Hoffman, PhD x, Fernando Holguin, MD, MPH m, Daniel J. Jackson, MD g, John James, MA c, Nizar N. Jarjour, MD g, Nicholas J. Kenyon, MD, MAS y, Sumita Khatri, MD, MS z, John P. Kirwan, MSc, PhD, FACSM aa, Monica Kraft, MD f, Jerry A. Krishnan, MD, PhD ab, Andrew H. Liu, MD l, m, Mark C. Liu, MD ac, M. Alison Marquis, MStat c, Fernando Martinez, MD f, Jacob Mey, PhD, RD aa, Wendy C. Moore, MD ad, James N. Moy, MD ae, Victor E. Ortega, MD ad, David B. Peden, MD, MS j, Emily Pennington, MD af, Michael C. Peters, MD v, Kristie Ross, MD af, ai, Maria Sanchez, BS c, Lewis J. Smith, MD ag, Ronald L. Sorkness, PhD g, Michael E. Wechsler, MD l, m, Sally E. Wenzel, MD h, Steven R. White, MD ah, Joe Zein, MD, MBA z, Amir A. Zeki, MD, MAS y, Patricia Noel, PhD qthe
PrecISE Study Team∗
Dean Billheimer, PhD, Eugene R. Bleecker, MD, Emily Branch, Michelle Conway, Cori Daines, MD, Isaac Deaton, Alexandria Evans, Paige Field, Dave Francisco, Annette T. Hastie, PhD, Bob Hmieleski, MBA, Jeffrey O. Krings, NP, Yanqin Liu, Janell L. Merchen, FNP-BC, Deborah A. Meyers, PhD, Nirushan Narendran, MS, Stephen P. Peters, MD, Anna Pippins, BS, Matthew A. Rank, MD, Ronald Schunk, RRT, Raymond Skeps, Benjamin Wright, Tina M. Banzon, MD, Lisa M. Bartnikas, MD, Sachin N. Baxi, MD, Vishwanath Betapudi, Isabelle Brick, Conor Brockway, Thomas B. Casale, MD, Kathleen Castillo-Ruano, Maria Angeles Cinelli, AB, Elena Crestani, MD, Amparito Cunningham, MD, Megan Day-Lewis, RN, MSN, Natalie Diaz-Cabrera, MD, Angela DiMango, MD, Brittany Esty, MD, MPH, Eva Fandozzi, Jesse Fernandez, Elizabeth Fitzpatrick, Victoria E. Forth, PA-C, Katarina Gentile, David Gubernick, MD, Seyni Gueye-Ndiaye, MD, Sigfus Gunnlaagsson, MD, Marissa Hauptmann, MD, Stephanie N. Hudey, MD, Donya S. Imanirad, MD, Tiffani Kaage, Nicholas Kolinsky, DO, Brenna LaBere, MD, Peggy Sue Lai, MD, Meghan Le, Dennis K. Ledford, MD, Richard Lockey, MD, Margee Louisias, MD, MPH, Andrew J. Macginnitie, MD, Michelle C. Maciag, MD, Allison O’Neill, Amber N. Pepper, MD, Perdita Permaul, MD, Mya Pugh, Dianna Queheillalt, RN, APRN, CPNP, AE-C, Tarnjot Saroya, William Sheehan, MD, Catherine Smith, Carmela Socolovsky, MD, Else Treffeisen, MD, Lorenzo Trippa, PhD, Abigail Tulchinsky, Christina Yee, MD, Tina Carter, Jun Fu, Vanessa Garcia, Jenny Hixon, Carly Jackson, Yuan Ji, PhD, Ravi Kalhan, MD, MS, Opinderjit Kaur, Grace Li, Melanie M. Makhija, MD, Spring Maleckar, Edward T. Naureckas, MD, Anju T. Peters, MD, MS, Valerie Press, MD, MPH, Mehreen Qureshi, Paul A. Reyfman, MD, Sharon R. Rosenberg, MD, Dominika Ryba, Jianrong Sheng, Ben Xu, Rafeul Alam, MD, PhD, Darci Anderson, Sonya Belimezova, Jennifer Bitzan, Geoffrey Chupp, MD, Brian J. Clark, MD, Lauren Cohn, MD, Margaret Hope Cruse, Jean Estrom, RN, BSN, Leah Freid, Jose Gomez Villalobos, MD, MS, Nicole Grant, MS, CCRP, Vamsi P. Guntur, MD, MSc, Carole Holm, RN, BSN, Christena Kolakowski, MS, Laurie A. Manka, MD, Naomi Miyazawa, PA, Juno Pak, BS, Diana M. Pruitt, RRT, CCRC, Sunita Sharma, MD, MPH, Allen D. Stevens, CCRC, NREMT, Kisori Thomas, Brooke Tippin, RN, BSN, CPN, Karissa Valente, Cynthia L. Wainscoat, RN, BSN, Michael P. White, BA, CCRC, Daniel Winnica, PhD, Shuyu Ye, Pamela L. Zeitlin, MD, MPhil, PhD, Julia Bach, BSN, RN, Joshua Brownell, MD, Lauren Castro, Julie DeLisa, MA, Sean B. Fain, PhD, Paul S. Fichtinger, Heather Floerke, James E. Gern, MD, Vinay Goswamy, MD, Jenelle Grogan, Wendy Hasse, Rick L. Kelley, Danika Klaus, BSN, RN, Stephanie LaBedz, MD, Paige Lowell, Andrew Maddox, Sameer K. Mathur, MD, PhD, Amanda McIntyre, MD, Lourdes M. Norwick, RN, Sharmilee M. Nyenhuis, MD, Matthew J. O’Brien, MS, RRT, Tina Palas, Andrea A. Pappalardo, MD, Mark Potter, MD, Sima K. Ramratnam, MD, Daniel L. Rosenberg, MD, Eric M. Schauberger, DO, PhD, Mark L. Schiebler, MD, Angela Schraml, Ronald L. Sorkness, PhD, Mohamed Taki, MD, Matthew C. Tattersall, MD, Jissell Torres, Lori Wollet, RN, Simon Abi-Saleh, Lisa Bendy, Larry Borish, MD, James F. Chmiel, MD, MPH, Aska Dix, Lisa France, Rebecca Gammell, Adam Gluvna, Brittany Hirth, Bo Hu, PhD, Elise Hyser, Kirsten M. Kloepfer, MD, MS, Michelle Koo, Nadia L. Krupp, MD, Monica Labadia, Joy Lawrence, Laurie Logan, Angela Marko, DO, Brittany Matuska, Deborah Murphy, Rachel Owensby, Erica A. Roesch, MD, Don B. Sanders, MD, Jackie Sharp, W. Gerald Teague, MD, Laura Veri, Kristin Wavell Shifflett, Matt Camiolo, MD, PhD, Sarah Collins, Jessa Demas, JD, Courtney Elvin, BS, Marc C. Gauthier, MD, Melissa Ilnicki, RRT, Jenn Ingram, BA, Lisa Lane, BS, Seyed Mehdi Nouraie, MD, PhD, John B. Trudeau, BA, Michael Zhang, MD, PhD, Jeffrey Barry, MD, MPH, Howard Brickner, Janelle Celso, Matejka Cernelc-Kohan, MD, Damaris Diaz, Ashley Du, Sonia Jain, PhD, Neiman Liu, Yusife Nazir, Julie Ryu, MD, Pandurangan Vijayanand, MD, PhD, Rogelio Almario, Ariana Baum, Kellen Brown, Marilynn H. Chan, MD, Barbara Gale, Angela Haczku, MD, PhD, Richart W. Harper, MD, Raymond Heromin, Celeste Kivler, Brooks T. Kuhn, MD, MAS, Ngoc P. Ly, MD, MPH, Paula McCourt, Xavier Orain, Audrey Plough, MSN, Karla Ramirez, Ellese Roberts, Michael Schivo, MD, MAS, Amisha Singapuri, Catherine Smith, Tina Tham, Daniel Tompkins, Patricia Michelle Twitmyer, Jade Vi, Jarron Atha, BS, Jennifer Bedard, Jonathan S. Boomer, PhD, Andrew Chung, Vanessa Curtis, Chase S. Hall, MD, Emily Hart, Fatima Jackson, Pamela Kemp, Sharli Maxwell, Maggie Messplay, Crystal Ramirez, Brynne Thompson, Ashley Britt, MS, Hope Bryan, Nathan M. Gotman, MS, Yue Jiang, PhD, Michael R. Kosorok, PhD, David T. Mauger, PhD, Kelsey Meekins, MS, Jeanette K. Mollenhauer, Sarah Moody, Cheyanne Ritz, MA, Stefanie Schwartz, MA, Chalmer Thomlinson, MS, Nicole Wilson, MS
a Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Rochester Medical Center, Rochester, NY
b Icahn School of Medicine at Mount Sinai, New York, NY
c Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC
d Department of Medicine, Divisions of Pulmonary & Critical Care Medicine & Allergy & Immunology, Brigham & Women’s Hospital, Harvard Medical School, Boston, Mass
e Pulmonary Division, Department of Medicine, University of California–San Diego, La Jolla, Calif
f Asthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz
g Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis
h University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh, Pa
i Lurie Children’s Hospital, Chicago, Ill
j Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC
k Boston Children’s Hospital and Harvard Medical School, Boston, Mass
l Children’s Hospital Colorado, Aurora, Colo
m University of Colorado School of Medicine, Aurora, Colo
n Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio
o Vanderbilt University School of Medicine, Nashville, Tenn
p University of Kansas School of Medicine, Kansas City, Mo
q Division of Lung Diseases, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Bethesda, Md
r Allergy and Immunology, University of South Florida, Tampa, Fla
s National Jewish Health, Denver, Colo
t Columbia University Medical Center, New York, NY
u Institute for Healthcare Delivery Design, University of Illinois at Chicago, Chicago, Ill
v University of California, San Francisco School of Medicine, San Francisco, Calif
w Wells Center for Pediatric Research, Indiana University, Indianapolis, Ind
x Department of Radiology, University of Iowa, Iowa City, Iowa
y Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, University of California Davis School of Medicine, Davis, Calif
z Respiratory Institute, Cleveland Clinic, Cleveland, Ohio
aa Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, La
ab Division of Pulmonary, Critical Care, Sleep, and Allergy, Department of Medicine, University of Illinois at Chicago, Chicago, Ill
ac Pulmonary and Critical Care Medicine, Department of Medicine, the Johns Hopkins University, Baltimore, Md
ad Wake Forest University School of Medicine, Winston-Salem, NC
ae Rush University Medical Center, Chicago, Ill
af The Cleveland Clinic, Cleveland, Ohio
ag Northwestern University, Chicago, Ill
ah Section of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, Chicago, Ill
ai UH Rainbow Babies and Children’s Hospitals, Cleveland, Ohio
∗Corresponding author: Steve N. Georas, MD, University of Rochester Medical Center, KMRB 2.9617, 601 Elmwood Ave, Rochester, NY 14620.University of Rochester Medical CenterKMRB 2.9617601 Elmwood AveRochesterNY14620
Abstract |
Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.
Le texte complet de cet article est disponible en PDF.Key words : Severe asthma, precision medicine, adaptive clinical trial design, asthma exacerbation, type 2 asthma, non–type 2 asthma, patient advisory committee, biomarker
Abbreviations used : ACQ-6, AE, CC, CompEx, COVID-19, CRP, DMCC, DSMB, EC, FDA, Feno, GSNO, GSNOR, ICS, IRB, JAK, MC, MCT, NHLBI, NO, PAC, PI, ppb, PPC, PrecISE, RFA, RTI, RV, SAE, SARP, SC, SNP, STAT, TCA, TLC, Treg
Plan
Procedures in the PrecISE network protocol
| The PrecISE study is funded by the National Heart, Lung, and Blood Institute, National Institutes of Health (grant nos. U24 HL138998, 1UG1HL139054, 1UG1HL139098, 1UG1HL139106, 1UG1HL139117, 1UG1HL139118, 1UG1HL139119, 1UG1HL139123, 1UG1HL139124, 1UG1HL139125, and 1UG1HL139126). Support for site institutional infrastructure came from National Institutes of Health Clinical & Translational Science Award grants (grant no. UL1TR002451 [Harvard], grant no. UL1TR000427 [University of Wisconsin], grant no. UL1TR002366 [University of Kansas], grant no. UL1TR002389 [University of Chicago], grant no. UL1TR002489 [University of North Carolina], grant no. UL1TR001857 [University of Pittsburgh], grant no. UL1TR001442 [University of California, San Diego], and grant no. UL1TR001872 [University of California, San Francisco]). The single institutional review board is supported by the Duke/Vanderbilt Trial Innovation Center (grant no. 5U24TR001608). The following endowed chair positions contributed additional support: Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research (E.I.), William W. and Judith H. Busse Professor of Allergy & Asthma Research (L.C.D.), and Walter and Carmina Parkes Family Endowed Professorship (S.N.G.). The study also gratefully acknowledges receiving contributed product from Vitaeris, owned and operated by the CSL group (clazakizumab), Vitaflo (MCT), Sun Pharma (imatinib), OM Pharma, a Vifor Pharma Group Company (OM-85, Broncho-Vaxom), Incyte (itacitinib), Laurel Venture (Cavosonstat), and GlaxoSmithKline (Advair Diskus and Ventolin). |
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| Disclosure of potential conflict of interest: S. N. Georas reports receiving grants from the National Institutes of Health (NIH) during the conduct of the study, and consulting fees from Merck outside of the submitted work. R. J. Wright reports grants from the NIH, during the conduct of the study. E. Israel reports grants from the NIH, Patient-Centered Outcomes Research Institute (PCORI), and Gossamer Bio; grants and nonfinancial support from Circassia; grants and personal fees from AstraZeneca, Avillion, and Novartis; personal fees and nonfinancial support from Genentech, GlaxoSmithKline (GSK), and Teva; personal fees from AB Science, Allergy and Asthma Network, Amgen, Arrowhead Pharmaceuticals, Biometry, Equillium, Merck, Pneuma Respiratory, the National Heart, Lung, and Blood Institute (NHLBI), PPS Health, Regeneron, Sanofi Genzyme, Sienna Biopharmaceutical, Teva, and Cowen; nonfinancial support from Boehringer Ingelheim; and other considerations from Vorso, outside the submitted work. L. M. LaVange reports grants from the NHLBI, during the conduct of the study. P. Akuthota reports grants from the NIH, during the conduct of the study; personal fees from WebMD/Medscape, AHK, Prime CME, UpToDate, Rockpointe, Projects in Knowledge, MJH LifeSciences, and Vindico CME, and grants and personal fees from GSK and AstraZeneca, outside the submitted work. T. F. Carr reports grants from the NHLBI, during the conduct of the study; grants and personal fees from AstraZeneca, Regeneron, and Novartis, and personal fees from GSK and Genentech, outside the submitted work. L. C. Denlinger reports grants from the NHLBI and American Lung Association / Asthma Clinical Research Centers, during the conduct of the study; and other considerations from AstraZeneca, Boehringer Ingelheim, Genentech, GSK, Sanofi-Genzyme-Regeneron, and Teva, outside the submitted work. M. L. Fajt reports personal fees from the American Academy of Allergy, Asthma & Immunology, and grants from Breathe PA Organization, outside the submitted work. W. Phipatanakul reports grants from Boehringer Ingelheim, and grants and personal fees from Genentech, Sanofi Regeneron, AstraZeneca, GlaxoSmithKline, Genzyme, and Teva, outside the submitted work. S. J. Szefler reports grants from Propeller Health, and other considerations from Moderna, GSK, AstraZeneca, Sanofi, and Regeneron, outside the submitted work. L. B. Bacharier reports grants from the NIH/NHLBI, during the conduct of the study; personal fees from GSK, Genentech/Novartis, DBV Technologies, AstraZeneca, WebMD/Medscape, Sanofi/Regeneron, Vectura, and Circassia, and personal fees and nonfinancial support from Merck, Teva, and Boehringer Ingelheim, outside the submitted work. M. Castro reports grants from the NIH, ALA, PCORI, Pulmatrix, and Shionogi; grants and personal fees from AstraZeneca, Novartis, GSK, and Sanofi-Aventis; and personal fees from Teva, Genentech, and Regeneron, outside the submitted work. J. C. Cardet reports personal fees from AstraZeneca, GSK, and Genentech, outside the submitted work. S. A. A. Comhair reports grants from the NHLBI, during the conduct of the study, and a patent, “Capric Acid and Myristic Acid Compositions for Treatment Conditions (publication no. 20200230094),” pending. R. A. Covar reports grants from the NHLBI, during the conduct of the study; grants from Avillion Bond, GSK, and American Lung Association/Asthma Clinical Research Centers (ALA/ACRC), and personal fees from Sanofi Regeneron, outside the submitted work. E. A. DiMango reports personal fees from AstraZeneca, outside the submitted work. K. Erwin reports grants from the NIH and the Robert Wood Johnson Foundation, grants and personal fees from the Arnold Foundation, and personal fees from the National Academy of Medicine and IIT Institute of Design, outside the submitted work. S. C. Erzurum reports grants from the NIH, during the conduct of the study. J. V. Fahy reports personal fees from Boehringer Ingelheim, Pieris, Arrowhead Pharmaceuticals, Gossamer, Ionis Pharmaceuticals, and Suzhou Connect Biopharmaceuticals, Ltd, outside the submitted work, and has a patent WO2014153009A2, “Thiosaccharide mucolytic agents,” issued, and a patent WO2017197360, “CT Mucus Score—A new scoring system that quantifies airway mucus impaction using CT lung scans,” pending. B. Gaston reports personal fees from Laurel, and other considerations from Respiratory Research, Inc, outside the submitted work. L. B. Gerald reports grants from the NIH, the Banner Health Foundation, the American Lung Association, and Thayer Medical Corporation; and personal fees from UpToDate, Wolters Kluwer, the University of Illinois, and the Nemours Foundation, outside the submitted work. E. A. Hoffman is a founder and shareholder of VIDA Diagnostics, a company commercializing lung image analysis software developed, in part, at the University of Iowa. D. J. Jackson reports grants from the NIH-Environmental Influences on Child Health Outcomes (ECHO)/Children’s Respiratory Research Workgroup (CREW), the NHLBI, and the National Institute of Allergy and Infectious Diseases (NIAID), during the conduct of the study; personal fees from Sanofi Regeneron, Pfizer, AstraZeneca, Novartis, and Vifor Pharma, and grants and personal fees from GlaxoSmithKline, outside the submitted work. N. N. Jarjour reports grants from the NIH-NHLBI during the conduct of the study; grants and personal fees from AstraZeneca, and personal fees from GSK and Boehringer Ingelheim for consultations outside the submitted work. M. Kraft reports grants from the NIH and the ALA; grants and personal fees from Sanofi Regeneron, Chiesi Pharmaceuticals, and AstraZeneca; and personal fees from Genentech, outside the submitted work. J. A. Krishnan reports grants from the NIH-NHLBI during the conduct of the study, grants from Regeneron, the COPD Foundation, and Sergey Brin Family Foundation, and personal fees from GSK, outside the submitted work. M. C. Liu reports grants from the NIH, during the conduct of the study; personal fees from UpToDate, grants and personal fees from Gossamer Bio and GSK, and other considerations from AstraZeneca, outside the submitted work. F. Martinez reports grants from the NIH/NHLBI, NIH/National Institute of Environmental Health Sciences, NIH/NIAID, and NIH/Office of Director, outside the submitted work. W. C. Moore reports grants from the NHLBI during the conduct of the study; grants and personal fees from AstraZeneca, GSK, and Sanofi Regeneron, and grants from Gossamer Bio, Inc, Cumberland Pharmaceuticals, and Genentech, outside the submitted work. V. E. Ortega reports personal fees from Regeneron and Sanofi, outside the submitted work. M. C. Peters reports grants from AstraZeneca, Boehringer Ingelheim, Genentech, GSK, Sanofi-Genzyme-Regeneron, and Teva, and personal fees from OrbiMed, outside the submitted work. K. Ross reports grants from the NIH, during the conduct of the study; grants and nonfinancial support from Teva; and grants from AstraZeneca and Novartis. L. J. Smith reports grants from the NHLBI, during the conduct of the study. M. E. Wechsler reports grants from the Jin Hua Foundation; grants, personal fees, and nonfinancial support from Teva; grants and personal fees from Sanofi, Regeneron, and Cohero Health; and personal fees from Amgen, GSK, Genentech, Novartis, Sentien, Restorbio, Equillium, Genzyme, Pulmatrix, Cytoreason, Cerecor, Incyte, Sound Biologics, Kinaset, Boehringer Ingelheim, and AstraZeneca, outside the submitted work. S. E. Wenzel reports grants from Teva; personal fees from Sanofi; and grants and personal fees from AstraZeneca, Knopp, and Novartis, outside the submitted work. S. R. White reports grants from the NHLBI, during the conduct of the study; and personal fees from Sanofi Regeneron and AstraZeneca, outside the submitted work. A. A. Zeki reports grants from InVixa, Inc; fees from Sanofi Regeneron and the Center for Healthcare Innovation (cIMBA); other considerations from InStatin, Inc, and InVixa, Inc, outside the submitted work; and has a patent PCT/US2020/025543 pending (no sponsor) and a Provisional Patent Application: Serial No. 63/158-144. UC 2020-551-2; 052564-563P02US. The rest of the authors declare that they have no relevant conflicts of interest. |
© 2021
The Authors. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 149 - N° 2
P. 488 - février 2022 Retour au numéro
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