Phase 2a randomized, placebo-controlled study of anti–IL-33 in peanut allergy

BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has previously demonstrated a good safety profile and favorable pharmacodynamic properties in many clinical studies.METHODSIn this 6-week placebo...

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Veröffentlicht in:	JCI insight Jg. 4; H. 22
Hauptverfasser:	Chinthrajah, Sharon, Cao, Shu, Liu, Cherie, Lyu, Shu-Chen, Sindher, Sayantani B., Long, Andrew, Sampath, Vanitha, Petroni, Daniel, Londei, Marco, Nadeau, Kari C.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States American Society for Clinical Investigation 14.11.2019
Schlagworte:	Adolescent Adult Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - pharmacology Antibodies, Monoclonal - therapeutic use Cells, Cultured Clinical Medicine Cytokines - metabolism Double-Blind Method Female Humans Interleukin-33 - antagonists & inhibitors Male Middle Aged Peanut Hypersensitivity - drug therapy Peanut Hypersensitivity - immunology Placebos T-Lymphocytes - drug effects T-Lymphocytes - metabolism Young Adult Allergy Clinical Trials Immunology
ISSN:	2379-3708, 2379-3708
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Abstract	BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has previously demonstrated a good safety profile and favorable pharmacodynamic properties in many clinical studies.METHODSIn this 6-week placebo-controlled phase 2a study, we evaluated the safety and the ability of a single dose of etokimab to desensitize peanut-allergic adults. Participants received either etokimab (n = 15) or blinded placebo (n = 5). Clinical tests included oral food challenges and skin prick tests at days 15 and 45. Blood samples were collected for IgE levels and measurement of ex vivo peanut-stimulated T cell cytokine production.RESULTSEfficacy measurements for active vs. placebo participants at the day 15 and 45 food challenge (tolerating a cumulative 275 mg of peanut protein, which was the food challenge outcome defined in this paper) demonstrated, respectively, 73% vs. 0% (P = 0.008) to 57% vs. 0% (ns). The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.TRIAL REGISTRATIONClinicalTrials.gov NCT02920021.FUNDINGThis work was supported by NIH grant R01AI140134, AnaptysBio, the Hartman Vaccine Fund, and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.
AbstractList	BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has previously demonstrated a good safety profile and favorable pharmacodynamic properties in many clinical studies.METHODSIn this 6-week placebo-controlled phase 2a study, we evaluated the safety and the ability of a single dose of etokimab to desensitize peanut-allergic adults. Participants received either etokimab (n = 15) or blinded placebo (n = 5). Clinical tests included oral food challenges and skin prick tests at days 15 and 45. Blood samples were collected for IgE levels and measurement of ex vivo peanut-stimulated T cell cytokine production.RESULTSEfficacy measurements for active vs. placebo participants at the day 15 and 45 food challenge (tolerating a cumulative 275 mg of peanut protein, which was the food challenge outcome defined in this paper) demonstrated, respectively, 73% vs. 0% (P = 0.008) to 57% vs. 0% (ns). The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.TRIAL REGISTRATIONClinicalTrials.gov NCT02920021.FUNDINGThis work was supported by NIH grant R01AI140134, AnaptysBio, the Hartman Vaccine Fund, and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University. BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has previously demonstrated a good safety profile and favorable pharmacodynamic properties in many clinical studies.METHODSIn this 6-week placebo-controlled phase 2a study, we evaluated the safety and the ability of a single dose of etokimab to desensitize peanut-allergic adults. Participants received either etokimab (n = 15) or blinded placebo (n = 5). Clinical tests included oral food challenges and skin prick tests at days 15 and 45. Blood samples were collected for IgE levels and measurement of ex vivo peanut-stimulated T cell cytokine production.RESULTSEfficacy measurements for active vs. placebo participants at the day 15 and 45 food challenge (tolerating a cumulative 275 mg of peanut protein, which was the food challenge outcome defined in this paper) demonstrated, respectively, 73% vs. 0% (P = 0.008) to 57% vs. 0% (ns). The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.TRIAL REGISTRATIONClinicalTrials.gov NCT02920021.FUNDINGThis work was supported by NIH grant R01AI140134, AnaptysBio, the Hartman Vaccine Fund, and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has previously demonstrated a good safety profile and favorable pharmacodynamic properties in many clinical studies.METHODSIn this 6-week placebo-controlled phase 2a study, we evaluated the safety and the ability of a single dose of etokimab to desensitize peanut-allergic adults. Participants received either etokimab (n = 15) or blinded placebo (n = 5). Clinical tests included oral food challenges and skin prick tests at days 15 and 45. Blood samples were collected for IgE levels and measurement of ex vivo peanut-stimulated T cell cytokine production.RESULTSEfficacy measurements for active vs. placebo participants at the day 15 and 45 food challenge (tolerating a cumulative 275 mg of peanut protein, which was the food challenge outcome defined in this paper) demonstrated, respectively, 73% vs. 0% (P = 0.008) to 57% vs. 0% (ns). The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.TRIAL REGISTRATIONClinicalTrials.gov NCT02920021.FUNDINGThis work was supported by NIH grant R01AI140134, AnaptysBio, the Hartman Vaccine Fund, and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University. A single dose of etokimab increased antigen tolerance in peanut-allergic participants and reduced atopy-related adverse events.
Author	Sindher, Sayantani B. Sampath, Vanitha Chinthrajah, Sharon Cao, Shu Nadeau, Kari C. Long, Andrew Lyu, Shu-Chen Londei, Marco Liu, Cherie Petroni, Daniel
AuthorAffiliation	4 ASTHMA Inc., Clinical Research Center, Northwest Asthma and Allergy Center, University of Washington, Seattle, Washington, USA 3 Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, California, USA 5 AnaptysBio Inc., San Diego, California, USA 1 Sean N. Parker Center for Allergy and Asthma Research at Stanford University 2 Division of Pulmonary, Allergy and Critical Care Medicine, and
AuthorAffiliation_xml	– name: 4 ASTHMA Inc., Clinical Research Center, Northwest Asthma and Allergy Center, University of Washington, Seattle, Washington, USA – name: 3 Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, California, USA – name: 2 Division of Pulmonary, Allergy and Critical Care Medicine, and – name: 5 AnaptysBio Inc., San Diego, California, USA – name: 1 Sean N. Parker Center for Allergy and Asthma Research at Stanford University
Author_xml	– sequence: 1 givenname: Sharon orcidid: 0000-0003-2467-4256 surname: Chinthrajah fullname: Chinthrajah, Sharon – sequence: 2 givenname: Shu surname: Cao fullname: Cao, Shu – sequence: 3 givenname: Cherie surname: Liu fullname: Liu, Cherie – sequence: 4 givenname: Shu-Chen surname: Lyu fullname: Lyu, Shu-Chen – sequence: 5 givenname: Sayantani B. surname: Sindher fullname: Sindher, Sayantani B. – sequence: 6 givenname: Andrew surname: Long fullname: Long, Andrew – sequence: 7 givenname: Vanitha orcidid: 0000-0001-9639-5024 surname: Sampath fullname: Sampath, Vanitha – sequence: 8 givenname: Daniel surname: Petroni fullname: Petroni, Daniel – sequence: 9 givenname: Marco surname: Londei fullname: Londei, Marco – sequence: 10 givenname: Kari C. orcidid: 0000-0002-2146-2955 surname: Nadeau fullname: Nadeau, Kari C.
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/31723064$$D View this record in MEDLINE/PubMed
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Snippet	BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has... A single dose of etokimab increased antigen tolerance in peanut-allergic participants and reduced atopy-related adverse events.
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SubjectTerms	Adolescent Adult Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - pharmacology Antibodies, Monoclonal - therapeutic use Cells, Cultured Clinical Medicine Cytokines - metabolism Double-Blind Method Female Humans Interleukin-33 - antagonists & inhibitors Male Middle Aged Peanut Hypersensitivity - drug therapy Peanut Hypersensitivity - immunology Placebos T-Lymphocytes - drug effects T-Lymphocytes - metabolism Young Adult
Title	Phase 2a randomized, placebo-controlled study of anti–IL-33 in peanut allergy
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