Benralizumab for PDGFRA-Negative Hypereosinophilic Syndrome

Benralizumab, an interleukin-5 receptor blocker, significantly reduced absolute eosinophil counts and relieved symptoms in a small group of patients with hypereosinophilic syndrome. Adverse events were similar in the benralizumab group and the placebo group.

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Bibliographic Details
Published inThe New England journal of medicine Vol. 380; no. 14; pp. 1336 - 1346
Main Authors Kuang, Fei Li, Legrand, Fanny, Makiya, Michelle, Ware, JeanAnne, Wetzler, Lauren, Brown, Thomas, Magee, Tamika, Piligian, Brent, Yoon, Pryscilla, Ellis, Jamie H, Sun, Xiaoping, Panch, Sandhya R, Powers, Astin, Alao, Hawwa, Kumar, Sheila, Quezado, Martha, Yan, Li, Lee, Nancy, Kolbeck, Roland, Newbold, Paul, Goldman, Mitchell, Fay, Michael P, Khoury, Paneez, Maric, Irina, Klion, Amy D
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 04.04.2019
Subjects
Allergies
Asthma
Bone marrow
Clinical trials
Cytokines
Double-blind studies
Drug dosages
Eosinophilia
FDA approval
Headache
Immunosuppressive agents
Infectious diseases
Interleukin 5
L-Lactate dehydrogenase
Lactic acid
Leukocytes (eosinophilic)
Monoclonal antibodies
Patients
R&D
Research & development
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Abstract Benralizumab, an interleukin-5 receptor blocker, significantly reduced absolute eosinophil counts and relieved symptoms in a small group of patients with hypereosinophilic syndrome. Adverse events were similar in the benralizumab group and the placebo group.
AbstractList BACKGROUNDHypereosinophilic syndrome is a group of diseases defined by marked eosinophilia in blood or tissue and eosinophil-related clinical manifestations. Benralizumab is a monoclonal antibody against interleukin-5 receptor α, which is expressed on human eosinophils. METHODSIn this randomized, double-blind, placebo-controlled, phase 2 trial, we administered a series of three monthly subcutaneous injections of either benralizumab (at a dose of 30 mg) or placebo in 20 symptomatic patients who had PDGFRA-negative hypereosinophilic syndrome and an absolute eosinophil count of at least 1000 cells per cubic millimeter; all the patients were receiving stable therapy (drugs or dietary changes) for this disease. This regimen was followed by an open-label phase, during which the patient's background therapy could be tapered as tolerated, and an extension phase. The primary end point of the randomized phase was a reduction of at least 50% in the absolute eosinophil count at week 12. RESULTSDuring the randomized phase, the primary end point occurred in more patients in the benralizumab group than in the placebo group (9 of 10 patients [90%] vs. 3 of 10 patients [30%], P = 0.02). During the open-label phase, clinical and hematologic responses were observed in 17 of 19 patients (89%) and were sustained for 48 weeks in 14 of 19 patients (74%); in the latter group, in 9 of 14 patients (64%), background therapies could be tapered. Bone marrow and tissue eosinophilia were also suppressed with benralizumab therapy. The most common drug-related adverse events, headache and an elevated lactate dehydrogenase level, occurred in 32% of the patients after the first dose of benralizumab and resolved within 48 hours in all patients. Other adverse events occurred with similar frequency in the two groups. Of the many potential predictors of response that were examined, only clinical disease subtype appeared to be associated with the initial response or relapse. CONCLUSIONSIn this small phase 2 trial, patients with PDGFRA-negative hypereosinophilic syndrome who received benralizumab for 12 weeks had lower absolute eosinophil counts than those who received placebo. During the open-label phase, clinical and hematologic responses were sustained for 48 weeks in 74% of the patients. Adverse events did not limit treatment. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov numbers, NCT00001406 and NCT02130882.).
Benralizumab, an interleukin-5 receptor blocker, significantly reduced absolute eosinophil counts and relieved symptoms in a small group of patients with hypereosinophilic syndrome. Adverse events were similar in the benralizumab group and the placebo group.
Hypereosinophilic syndrome is a group of diseases defined by marked eosinophilia in blood or tissue and eosinophil-related clinical manifestations. Benralizumab is a monoclonal antibody against interleukin-5 receptor α, which is expressed on human eosinophils. In this randomized, double-blind, placebo-controlled, phase 2 trial, we administered a series of three monthly subcutaneous injections of either benralizumab (at a dose of 30 mg) or placebo in 20 symptomatic patients who had -negative hypereosinophilic syndrome and an absolute eosinophil count of at least 1000 cells per cubic millimeter; all the patients were receiving stable therapy (drugs or dietary changes) for this disease. This regimen was followed by an open-label phase, during which the patient's background therapy could be tapered as tolerated, and an extension phase. The primary end point of the randomized phase was a reduction of at least 50% in the absolute eosinophil count at week 12. During the randomized phase, the primary end point occurred in more patients in the benralizumab group than in the placebo group (9 of 10 patients [90%] vs. 3 of 10 patients [30%], P = 0.02). During the open-label phase, clinical and hematologic responses were observed in 17 of 19 patients (89%) and were sustained for 48 weeks in 14 of 19 patients (74%); in the latter group, in 9 of 14 patients (64%), background therapies could be tapered. Bone marrow and tissue eosinophilia were also suppressed with benralizumab therapy. The most common drug-related adverse events, headache and an elevated lactate dehydrogenase level, occurred in 32% of the patients after the first dose of benralizumab and resolved within 48 hours in all patients. Other adverse events occurred with similar frequency in the two groups. Of the many potential predictors of response that were examined, only clinical disease subtype appeared to be associated with the initial response or relapse. In this small phase 2 trial, patients with -negative hypereosinophilic syndrome who received benralizumab for 12 weeks had lower absolute eosinophil counts than those who received placebo. During the open-label phase, clinical and hematologic responses were sustained for 48 weeks in 74% of the patients. Adverse events did not limit treatment. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov numbers, NCT00001406 and NCT02130882.).
Author Piligian, Brent
Khoury, Paneez
Makiya, Michelle
Ellis, Jamie H
Kumar, Sheila
Magee, Tamika
Alao, Hawwa
Legrand, Fanny
Kuang, Fei Li
Sun, Xiaoping
Lee, Nancy
Klion, Amy D
Quezado, Martha
Kolbeck, Roland
Yan, Li
Yoon, Pryscilla
Newbold, Paul
Goldman, Mitchell
Fay, Michael P
Ware, JeanAnne
Wetzler, Lauren
Panch, Sandhya R
Brown, Thomas
Powers, Astin
Maric, Irina
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  givenname: Fei Li
  surname: Kuang
  fullname: Kuang, Fei Li
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
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  givenname: Fanny
  surname: Legrand
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  givenname: JeanAnne
  surname: Ware
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  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 5
  givenname: Lauren
  surname: Wetzler
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  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 6
  givenname: Thomas
  surname: Brown
  fullname: Brown, Thomas
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 7
  givenname: Tamika
  surname: Magee
  fullname: Magee, Tamika
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 8
  givenname: Brent
  surname: Piligian
  fullname: Piligian, Brent
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 9
  givenname: Pryscilla
  surname: Yoon
  fullname: Yoon, Pryscilla
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
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  givenname: Jamie H
  surname: Ellis
  fullname: Ellis, Jamie H
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 11
  givenname: Xiaoping
  surname: Sun
  fullname: Sun, Xiaoping
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 12
  givenname: Sandhya R
  surname: Panch
  fullname: Panch, Sandhya R
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 13
  givenname: Astin
  surname: Powers
  fullname: Powers, Astin
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 14
  givenname: Hawwa
  surname: Alao
  fullname: Alao, Hawwa
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 15
  givenname: Sheila
  surname: Kumar
  fullname: Kumar, Sheila
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 16
  givenname: Martha
  surname: Quezado
  fullname: Quezado, Martha
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 17
  givenname: Li
  surname: Yan
  fullname: Yan, Li
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 18
  givenname: Nancy
  surname: Lee
  fullname: Lee, Nancy
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 19
  givenname: Roland
  surname: Kolbeck
  fullname: Kolbeck, Roland
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 20
  givenname: Paul
  surname: Newbold
  fullname: Newbold, Paul
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 21
  givenname: Mitchell
  surname: Goldman
  fullname: Goldman, Mitchell
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 22
  givenname: Michael P
  surname: Fay
  fullname: Fay, Michael P
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
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  givenname: Paneez
  surname: Khoury
  fullname: Khoury, Paneez
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 24
  givenname: Irina
  surname: Maric
  fullname: Maric, Irina
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
– sequence: 25
  givenname: Amy D
  surname: Klion
  fullname: Klion, Amy D
  organization: From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg — all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.)
BackLink https://www.ncbi.nlm.nih.gov/pubmed/30943337$$D View this record in MEDLINE/PubMed
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Snippet Benralizumab, an interleukin-5 receptor blocker, significantly reduced absolute eosinophil counts and relieved symptoms in a small group of patients with...
Hypereosinophilic syndrome is a group of diseases defined by marked eosinophilia in blood or tissue and eosinophil-related clinical manifestations....
BackgroundHypereosinophilic syndrome is a group of diseases defined by marked eosinophilia in blood or tissue and eosinophil-related clinical manifestations....
BACKGROUNDHypereosinophilic syndrome is a group of diseases defined by marked eosinophilia in blood or tissue and eosinophil-related clinical manifestations....
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SubjectTerms Allergies
Asthma
Bone marrow
Clinical trials
Cytokines
Double-blind studies
Drug dosages
Eosinophilia
FDA approval
Headache
Immunosuppressive agents
Infectious diseases
Interleukin 5
L-Lactate dehydrogenase
Lactic acid
Leukocytes (eosinophilic)
Monoclonal antibodies
Patients
R&D
Research & development
Title Benralizumab for PDGFRA-Negative Hypereosinophilic Syndrome
URI https://nejm.org/doi/full/10.1056/NEJMoa1812185
https://www.ncbi.nlm.nih.gov/pubmed/30943337
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