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Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma

Castro, Mario
Author Castro, Mario From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Corren, Jonathan
Author Corren, Jonathan From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Pavord, Ian D
Author Pavord, Ian D From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Maspero, Jorge
Author Maspero, Jorge From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Wenzel, Sally
Author Wenzel, Sally From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Rabe, Klaus F
Author Rabe, Klaus F From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Busse, William W
Author Busse, William W From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Ford, Linda
Author Ford, Linda From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Sher, Lawrence
Author Sher, Lawrence From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
FitzGerald, J Mark
Author FitzGerald, J Mark From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Katelaris, Constance
Author Katelaris, Constance From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Tohda, Yuji
Author Tohda, Yuji From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Zhang, Bingzhi
Author Zhang, Bingzhi From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Staudinger, Heribert
Author Staudinger, Heribert From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Pirozzi, Gianluca
Author Pirozzi, Gianluca From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Amin, Nikhil
Author Amin, Nikhil From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Ruddy, Marcella
Author Ruddy, Marcella From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Akinlade, Bolanle
Author Akinlade, Bolanle From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Khan, Asif
Author Khan, Asif From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Chao, Jingdong
Author Chao, Jingdong From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Martincova, Renata
Author Martincova, Renata From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Graham, Neil M H
Author Graham, Neil M H From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Hamilton, Jennifer D
Author Hamilton, Jennifer D From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Swanson, Brian N
Author Swanson, Brian N From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Stahl, Neil
Author Stahl, Neil From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Yancopoulos, George D
Author Yancopoulos, George D From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)
Teper, Ariel
Author Teper, Ariel From the Washington University School of Medicine, St. Louis (M.C.); David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J. Corren), and Peninsula Research Associates, Rolling Hills Estates (L.S.) - both in California; Oxford Respiratory National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom (I.D.P.); Fundación CIDEA (Centro de Investigación de Enfermedades Alérgicas y Respiratorias), Buenos Aires (J.M.); the University of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh (S.W.); LungenClinic Grosshansdorf, Grosshansdorf, and Christian Albrechts University Kiel, Kiel - both in Germany (K.F.R.); the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison (W.W.B.); the Asthma and Allergy Center, Bellevue, NE (L.F.); the University of British Columbia, Vancouver, Canada (J.M.F.); Campbelltown Hospital and Western Sydney University, Sydney (C.K.); the Faculty of Medicine, Kindai University, Osakasayama, Japan (Y.T.); Sanofi, Bridgewater, NJ (B.Z., H.S., G.P., B.N.S., A.T.); Regeneron Pharmaceuticals, Tarrytown, NY (N.A., M.R., B.A., J. Chao, N.M.H.G., J.D.H., N.S., G.D.Y.); Sanofi, Chilly-Mazarin, France (A.K.); and Sanofi, Prague, Czech Republic (R.M.)

The New England journal of medicine. 2018 Jun 28 ; 378 (26) : 2486-2496. [epub] 20180521

N Engl J Med
ISSN 1533-4406 | 0028-4793
Source

Language English Country United States Media print-electronic

Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link https://www.medvik.cz/link/pmid29782217

PubMed 29782217
DOI 10.1056/nejmoa1804092
Knihovny.cz E-resources

MeSH
Intention to Treat Analysis MeSH
Anti-Asthmatic Agents adverse effects pharmacology therapeutic use MeSH
Asthma classification drug therapy MeSH
Bronchodilator Agents therapeutic use MeSH
Child MeSH
Adult MeSH
Double-Blind Method MeSH
Eosinophilia chemically induced MeSH
Antibodies, Monoclonal, Humanized MeSH
Injections, Subcutaneous adverse effects MeSH
Interleukin-13 MeSH
Drug Therapy, Combination MeSH
Middle Aged MeSH
Humans MeSH
Adolescent MeSH
Young Adult MeSH
Antibodies, Monoclonal adverse effects pharmacology therapeutic use MeSH
Receptors, Interleukin-4 antagonists & inhibitors MeSH
Forced Expiratory Volume drug effects MeSH
Check Tag
Child MeSH
Adult MeSH
Middle Aged MeSH
Humans MeSH
Adolescent MeSH
Young Adult MeSH
Male MeSH
Female MeSH
Publication type
Journal Article MeSH
Clinical Trial, Phase III MeSH
Multicenter Study MeSH
Research Support, Non-U.S. Gov't MeSH
Randomized Controlled Trial MeSH
Names of Substances
Anti-Asthmatic Agents MeSH
Bronchodilator Agents MeSH
dupilumab MeSH Browser
Antibodies, Monoclonal, Humanized MeSH
Interleukin-13 MeSH
Antibodies, Monoclonal MeSH
Receptors, Interleukin-4 MeSH

BACKGROUND: Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. We assessed its efficacy and safety in patients with uncontrolled asthma. METHODS: We randomly assigned 1902 patients 12 years of age or older with uncontrolled asthma in a 2:2:1:1 ratio to receive add-on subcutaneous dupilumab at a dose of 200 or 300 mg every 2 weeks or matched-volume placebos for 52 weeks. The primary end points were the annualized rate of severe asthma exacerbations and the absolute change from baseline to week 12 in the forced expiratory volume in 1 second (FEV1) before bronchodilator use in the overall trial population. Secondary end points included the exacerbation rate and FEV1 in patients with a blood eosinophil count of 300 or more per cubic millimeter. Asthma control and dupilumab safety were also assessed. RESULTS: The annualized rate of severe asthma exacerbations was 0.46 (95% confidence interval [CI], 0.39 to 0.53) among patients assigned to 200 mg of dupilumab every 2 weeks and 0.87 (95% CI, 0.72 to 1.05) among those assigned to a matched placebo, for a 47.7% lower rate with dupilumab than with placebo (P<0.001); similar results were seen with the dupilumab dose of 300 mg every 2 weeks. At week 12, the FEV1 had increased by 0.32 liters in patients assigned to the lower dose of dupilumab (difference vs. matched placebo, 0.14 liters; P<0.001); similar results were seen with the higher dose. Among patients with a blood eosinophil count of 300 or more per cubic millimeter, the annualized rate of severe asthma exacerbations was 0.37 (95% CI, 0.29 to 0.48) among those receiving lower-dose dupilumab and 1.08 (95% CI, 0.85 to 1.38) among those receiving a matched placebo (65.8% lower rate with dupilumab than with placebo; 95% CI, 52.0 to 75.6); similar results were observed with the higher dose. Blood eosinophilia occurred after the start of the intervention in 52 patients (4.1%) who received dupilumab as compared with 4 patients (0.6%) who received placebo. CONCLUSIONS: In this trial, patients who received dupilumab had significantly lower rates of severe asthma exacerbation than those who received placebo, as well as better lung function and asthma control. Greater benefits were seen in patients with higher baseline levels of eosinophils. Hypereosinophilia was observed in some patients. (Funded by Sanofi and Regeneron Pharmaceuticals; LIBERTY ASTHMA QUEST ClinicalTrials.gov number, NCT02414854 .).

From the Washington University School of Medicine St Louis

Comment In

N Engl J Med. 2018 Jun 28;378(26):2533-2534. doi: 10.1056/NEJMe1806037. PubMed

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