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Anti‐KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria
Background Chronic inducible urticaria (CIndU) is characterized by mast cell (MC)‐mediated wheals in response to triggers: cold in cold urticaria (ColdU) and friction in symptomatic dermographism (SD). KIT receptor activation by stem cell factor (SCF) is essential for MC function. Barzolvolimab (CDX...
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| Published in: | Allergy (Copenhagen) 2023-05, Vol.78 (5), p.1269-1279 |
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| creator | Terhorst‐Molawi, Dorothea Hawro, Tomasz Grekowitz, Eva Kiefer, Lea Merchant, Kunal Alvarado, Diego Thomas, Lawrence J. Hawthorne, Thomas Crowley, Elizabeth Heath‐Chiozzi, Margo Metz, Martin Maurer, Marcus |
| description | Background
Chronic inducible urticaria (CIndU) is characterized by mast cell (MC)‐mediated wheals in response to triggers: cold in cold urticaria (ColdU) and friction in symptomatic dermographism (SD). KIT receptor activation by stem cell factor (SCF) is essential for MC function. Barzolvolimab (CDX‐0159) is a humanized antibody that inhibits KIT activation by SCF and was well tolerated in healthy volunteers with dose‐dependent plasma tryptase suppression indicative of systemic mast cell ablation.
Methods
This is an open‐label, trial in patients with antihistamine refractory ColdU or SD, receiving one IV dose of barzolvolimab (3 mg/kg), with a 12‐week follow‐up. Primary endpoint was safety/tolerability; pharmacodynamic (PD)/clinical endpoints included serum tryptase, plasma SCF, skin MC histology, provocation tests, urticaria control test (UCT), and dermatology life quality index (DLQI).
Results
Analysis populations were safety (n = 21) and pharmacodynamics/clinical activity (n = 20). Barzolvolimab was well tolerated; most adverse events were mild and resolved. Treatment resulted in significant depletion of skin MCs, decreased tryptase ( |
| doi_str_mv | 10.1111/all.15585 |
| format | article |
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Chronic inducible urticaria (CIndU) is characterized by mast cell (MC)‐mediated wheals in response to triggers: cold in cold urticaria (ColdU) and friction in symptomatic dermographism (SD). KIT receptor activation by stem cell factor (SCF) is essential for MC function. Barzolvolimab (CDX‐0159) is a humanized antibody that inhibits KIT activation by SCF and was well tolerated in healthy volunteers with dose‐dependent plasma tryptase suppression indicative of systemic mast cell ablation.
Methods
This is an open‐label, trial in patients with antihistamine refractory ColdU or SD, receiving one IV dose of barzolvolimab (3 mg/kg), with a 12‐week follow‐up. Primary endpoint was safety/tolerability; pharmacodynamic (PD)/clinical endpoints included serum tryptase, plasma SCF, skin MC histology, provocation tests, urticaria control test (UCT), and dermatology life quality index (DLQI).
Results
Analysis populations were safety (n = 21) and pharmacodynamics/clinical activity (n = 20). Barzolvolimab was well tolerated; most adverse events were mild and resolved. Treatment resulted in significant depletion of skin MCs, decreased tryptase (<limit of detection), and increased soluble SCF through Week 12. Complete responses (negative provocation test) occurred in 95% (n = 19/20) of patients (n = 10/10 ColdU; n = 9/10 SD), and all (n = 20/20) showed improvement in urticaria control (UCT ≥ 12). The kinetics of clinical activity mirrored that of MC and tryptase reduction. DLQI‐measured impairment significantly decreased to minimal/none in 93% of patients on study.
Conclusion
In CIndU patients, barzolvolimab was well tolerated, demonstrated marked, rapid, durable depletion of skin MCs, circulating tryptase, and reductions in clinical activity with significant improvements in disease control and quality of life (QoL) demonstrating potential therapeutic effects for MC‐mediated disorders.
In this Phase 1b study of CIndU (ColdU and SD) patients, barzolvolimab, a humanized antibody that inhibits KIT activation by SCF, was well tolerated. Barzolvolimab demonstrated marked, rapid, durable depletion of skin MCs, circulating tryptase, reductions in clinical activity, and significant improvements in disease control and QoL. Barzolvolimab has potential as a therapy for MC‐mediated diseases.Abbreviations: CIndU, chronic inducible urticaria; ColdU, cold urticaria; FcR, Fc receptor; Ig, immunoglobulin; KIT, KIT proto‐oncogene, receptor tyrosine kinase; MC, mast cell; MRGPRX2, mas‐related G protein‐coupled receptor‐X2; QoL, quality of life; SCF, stem cell factor; SD, symptomatic dermographism</description><identifier>ISSN: 0105-4538</identifier><identifier>EISSN: 1398-9995</identifier><identifier>DOI: 10.1111/all.15585</identifier><identifier>PMID: 36385701</identifier><language>eng</language><publisher>Denmark: Blackwell Publishing Ltd</publisher><subject>Antihistamines ; barzolvolimab ; CDX‐0159 ; Cell activation ; Chronic Disease ; Chronic Inducible Urticaria ; cold urticaria ; Disease control ; Humans ; Mast cells ; Mast Cells - pathology ; Patients ; Pharmacodynamics ; Proto-Oncogene Proteins c-kit ; Provocation tests ; Quality of Life ; Receptor mechanisms ; Skin diseases ; Skin tests ; Stem cell factor ; symptomatic dermographism ; Tryptase ; Tryptases ; Urticaria ; Urticaria - diagnosis ; Urticaria - drug therapy</subject><ispartof>Allergy (Copenhagen), 2023-05, Vol.78 (5), p.1269-1279</ispartof><rights>2022 The Authors. published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.</rights><rights>2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.</rights><rights>2022. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4195-a7f8bf773e6ed006d7dd4d879786856d4b9696ef39b2c3df961d0be6366558053</citedby><cites>FETCH-LOGICAL-c4195-a7f8bf773e6ed006d7dd4d879786856d4b9696ef39b2c3df961d0be6366558053</cites><orcidid>0000-0001-9411-8998 ; 0000-0003-2882-4784 ; 0000-0002-4070-9976 ; 0000-0002-5878-1730 ; 0000-0001-9990-1332 ; 0000-0002-7356-7126 ; 0000-0002-4121-481X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36385701$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Terhorst‐Molawi, Dorothea</creatorcontrib><creatorcontrib>Hawro, Tomasz</creatorcontrib><creatorcontrib>Grekowitz, Eva</creatorcontrib><creatorcontrib>Kiefer, Lea</creatorcontrib><creatorcontrib>Merchant, Kunal</creatorcontrib><creatorcontrib>Alvarado, Diego</creatorcontrib><creatorcontrib>Thomas, Lawrence J.</creatorcontrib><creatorcontrib>Hawthorne, Thomas</creatorcontrib><creatorcontrib>Crowley, Elizabeth</creatorcontrib><creatorcontrib>Heath‐Chiozzi, Margo</creatorcontrib><creatorcontrib>Metz, Martin</creatorcontrib><creatorcontrib>Maurer, Marcus</creatorcontrib><title>Anti‐KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria</title><title>Allergy (Copenhagen)</title><addtitle>Allergy</addtitle><description>Background
Chronic inducible urticaria (CIndU) is characterized by mast cell (MC)‐mediated wheals in response to triggers: cold in cold urticaria (ColdU) and friction in symptomatic dermographism (SD). KIT receptor activation by stem cell factor (SCF) is essential for MC function. Barzolvolimab (CDX‐0159) is a humanized antibody that inhibits KIT activation by SCF and was well tolerated in healthy volunteers with dose‐dependent plasma tryptase suppression indicative of systemic mast cell ablation.
Methods
This is an open‐label, trial in patients with antihistamine refractory ColdU or SD, receiving one IV dose of barzolvolimab (3 mg/kg), with a 12‐week follow‐up. Primary endpoint was safety/tolerability; pharmacodynamic (PD)/clinical endpoints included serum tryptase, plasma SCF, skin MC histology, provocation tests, urticaria control test (UCT), and dermatology life quality index (DLQI).
Results
Analysis populations were safety (n = 21) and pharmacodynamics/clinical activity (n = 20). Barzolvolimab was well tolerated; most adverse events were mild and resolved. Treatment resulted in significant depletion of skin MCs, decreased tryptase (<limit of detection), and increased soluble SCF through Week 12. Complete responses (negative provocation test) occurred in 95% (n = 19/20) of patients (n = 10/10 ColdU; n = 9/10 SD), and all (n = 20/20) showed improvement in urticaria control (UCT ≥ 12). The kinetics of clinical activity mirrored that of MC and tryptase reduction. DLQI‐measured impairment significantly decreased to minimal/none in 93% of patients on study.
Conclusion
In CIndU patients, barzolvolimab was well tolerated, demonstrated marked, rapid, durable depletion of skin MCs, circulating tryptase, and reductions in clinical activity with significant improvements in disease control and quality of life (QoL) demonstrating potential therapeutic effects for MC‐mediated disorders.
In this Phase 1b study of CIndU (ColdU and SD) patients, barzolvolimab, a humanized antibody that inhibits KIT activation by SCF, was well tolerated. Barzolvolimab demonstrated marked, rapid, durable depletion of skin MCs, circulating tryptase, reductions in clinical activity, and significant improvements in disease control and QoL. Barzolvolimab has potential as a therapy for MC‐mediated diseases.Abbreviations: CIndU, chronic inducible urticaria; ColdU, cold urticaria; FcR, Fc receptor; Ig, immunoglobulin; KIT, KIT proto‐oncogene, receptor tyrosine kinase; MC, mast cell; MRGPRX2, mas‐related G protein‐coupled receptor‐X2; QoL, quality of life; SCF, stem cell factor; SD, symptomatic dermographism</description><subject>Antihistamines</subject><subject>barzolvolimab</subject><subject>CDX‐0159</subject><subject>Cell activation</subject><subject>Chronic Disease</subject><subject>Chronic Inducible Urticaria</subject><subject>cold urticaria</subject><subject>Disease control</subject><subject>Humans</subject><subject>Mast cells</subject><subject>Mast Cells - pathology</subject><subject>Patients</subject><subject>Pharmacodynamics</subject><subject>Proto-Oncogene Proteins c-kit</subject><subject>Provocation tests</subject><subject>Quality of Life</subject><subject>Receptor mechanisms</subject><subject>Skin diseases</subject><subject>Skin tests</subject><subject>Stem cell factor</subject><subject>symptomatic dermographism</subject><subject>Tryptase</subject><subject>Tryptases</subject><subject>Urticaria</subject><subject>Urticaria - diagnosis</subject><subject>Urticaria - drug therapy</subject><issn>0105-4538</issn><issn>1398-9995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1kc1OGzEUha2qqATaBS9QWeqmSBlix-O_ZYRaQETqhq4t_41w6ozBngGlqz5Cn5EnwZDAAom7uXfxnaOrcwA4wugE15npGE8wpYJ-ABNMpGiklPQjmCCMaNNSIvbBQSkrhBCfS_QJ7BNGBOUIT0Ba9EN4-Pf_8uIK6nqa5DZTaHT-m-JdimGtzRRm70brCyx_Qg_XugzQ-hhLFTjoQvG6eKjtEO7CsIEVsdc59cHWs-qCiR6OeQhW56A_g71Ox-K_7PYh-P3zx9XpebP8dXZxulg2tsWSNpp3wnScE8-8Q4g57lzrBJdcMEGZa41kkvmOSDO3xHWSYYeMZ4SxmgOi5BB83_re5HQ7-jKodShPX-vep7GoOSe8ZQwJUtFvb9BVGnNfv1NzgTgXkvO2UsdbyuZUSvadusk1nbxRGKmnFlRtQT23UNmvO8fRrL17JV9ir8BsC9yH6DfvO6nFcrm1fATQypHw</recordid><startdate>202305</startdate><enddate>202305</enddate><creator>Terhorst‐Molawi, Dorothea</creator><creator>Hawro, Tomasz</creator><creator>Grekowitz, Eva</creator><creator>Kiefer, Lea</creator><creator>Merchant, Kunal</creator><creator>Alvarado, Diego</creator><creator>Thomas, Lawrence J.</creator><creator>Hawthorne, Thomas</creator><creator>Crowley, Elizabeth</creator><creator>Heath‐Chiozzi, Margo</creator><creator>Metz, Martin</creator><creator>Maurer, Marcus</creator><general>Blackwell Publishing Ltd</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-9411-8998</orcidid><orcidid>https://orcid.org/0000-0003-2882-4784</orcidid><orcidid>https://orcid.org/0000-0002-4070-9976</orcidid><orcidid>https://orcid.org/0000-0002-5878-1730</orcidid><orcidid>https://orcid.org/0000-0001-9990-1332</orcidid><orcidid>https://orcid.org/0000-0002-7356-7126</orcidid><orcidid>https://orcid.org/0000-0002-4121-481X</orcidid></search><sort><creationdate>202305</creationdate><title>Anti‐KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria</title><author>Terhorst‐Molawi, Dorothea ; Hawro, Tomasz ; Grekowitz, Eva ; Kiefer, Lea ; Merchant, Kunal ; Alvarado, Diego ; Thomas, Lawrence J. ; Hawthorne, Thomas ; Crowley, Elizabeth ; Heath‐Chiozzi, Margo ; Metz, Martin ; Maurer, Marcus</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4195-a7f8bf773e6ed006d7dd4d879786856d4b9696ef39b2c3df961d0be6366558053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antihistamines</topic><topic>barzolvolimab</topic><topic>CDX‐0159</topic><topic>Cell activation</topic><topic>Chronic Disease</topic><topic>Chronic Inducible Urticaria</topic><topic>cold urticaria</topic><topic>Disease control</topic><topic>Humans</topic><topic>Mast cells</topic><topic>Mast Cells - pathology</topic><topic>Patients</topic><topic>Pharmacodynamics</topic><topic>Proto-Oncogene Proteins c-kit</topic><topic>Provocation tests</topic><topic>Quality of Life</topic><topic>Receptor mechanisms</topic><topic>Skin diseases</topic><topic>Skin tests</topic><topic>Stem cell factor</topic><topic>symptomatic dermographism</topic><topic>Tryptase</topic><topic>Tryptases</topic><topic>Urticaria</topic><topic>Urticaria - diagnosis</topic><topic>Urticaria - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Terhorst‐Molawi, Dorothea</creatorcontrib><creatorcontrib>Hawro, Tomasz</creatorcontrib><creatorcontrib>Grekowitz, Eva</creatorcontrib><creatorcontrib>Kiefer, Lea</creatorcontrib><creatorcontrib>Merchant, Kunal</creatorcontrib><creatorcontrib>Alvarado, Diego</creatorcontrib><creatorcontrib>Thomas, Lawrence J.</creatorcontrib><creatorcontrib>Hawthorne, Thomas</creatorcontrib><creatorcontrib>Crowley, Elizabeth</creatorcontrib><creatorcontrib>Heath‐Chiozzi, Margo</creatorcontrib><creatorcontrib>Metz, Martin</creatorcontrib><creatorcontrib>Maurer, Marcus</creatorcontrib><collection>Open Access: Wiley-Blackwell Open Access Journals</collection><collection>Wiley-Blackwell Free Backfiles(OpenAccess)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Allergy (Copenhagen)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Terhorst‐Molawi, Dorothea</au><au>Hawro, Tomasz</au><au>Grekowitz, Eva</au><au>Kiefer, Lea</au><au>Merchant, Kunal</au><au>Alvarado, Diego</au><au>Thomas, Lawrence J.</au><au>Hawthorne, Thomas</au><au>Crowley, Elizabeth</au><au>Heath‐Chiozzi, Margo</au><au>Metz, Martin</au><au>Maurer, Marcus</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Anti‐KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria</atitle><jtitle>Allergy (Copenhagen)</jtitle><addtitle>Allergy</addtitle><date>2023-05</date><risdate>2023</risdate><volume>78</volume><issue>5</issue><spage>1269</spage><epage>1279</epage><pages>1269-1279</pages><issn>0105-4538</issn><eissn>1398-9995</eissn><abstract>Background
Chronic inducible urticaria (CIndU) is characterized by mast cell (MC)‐mediated wheals in response to triggers: cold in cold urticaria (ColdU) and friction in symptomatic dermographism (SD). KIT receptor activation by stem cell factor (SCF) is essential for MC function. Barzolvolimab (CDX‐0159) is a humanized antibody that inhibits KIT activation by SCF and was well tolerated in healthy volunteers with dose‐dependent plasma tryptase suppression indicative of systemic mast cell ablation.
Methods
This is an open‐label, trial in patients with antihistamine refractory ColdU or SD, receiving one IV dose of barzolvolimab (3 mg/kg), with a 12‐week follow‐up. Primary endpoint was safety/tolerability; pharmacodynamic (PD)/clinical endpoints included serum tryptase, plasma SCF, skin MC histology, provocation tests, urticaria control test (UCT), and dermatology life quality index (DLQI).
Results
Analysis populations were safety (n = 21) and pharmacodynamics/clinical activity (n = 20). Barzolvolimab was well tolerated; most adverse events were mild and resolved. Treatment resulted in significant depletion of skin MCs, decreased tryptase (<limit of detection), and increased soluble SCF through Week 12. Complete responses (negative provocation test) occurred in 95% (n = 19/20) of patients (n = 10/10 ColdU; n = 9/10 SD), and all (n = 20/20) showed improvement in urticaria control (UCT ≥ 12). The kinetics of clinical activity mirrored that of MC and tryptase reduction. DLQI‐measured impairment significantly decreased to minimal/none in 93% of patients on study.
Conclusion
In CIndU patients, barzolvolimab was well tolerated, demonstrated marked, rapid, durable depletion of skin MCs, circulating tryptase, and reductions in clinical activity with significant improvements in disease control and quality of life (QoL) demonstrating potential therapeutic effects for MC‐mediated disorders.
In this Phase 1b study of CIndU (ColdU and SD) patients, barzolvolimab, a humanized antibody that inhibits KIT activation by SCF, was well tolerated. Barzolvolimab demonstrated marked, rapid, durable depletion of skin MCs, circulating tryptase, reductions in clinical activity, and significant improvements in disease control and QoL. Barzolvolimab has potential as a therapy for MC‐mediated diseases.Abbreviations: CIndU, chronic inducible urticaria; ColdU, cold urticaria; FcR, Fc receptor; Ig, immunoglobulin; KIT, KIT proto‐oncogene, receptor tyrosine kinase; MC, mast cell; MRGPRX2, mas‐related G protein‐coupled receptor‐X2; QoL, quality of life; SCF, stem cell factor; SD, symptomatic dermographism</abstract><cop>Denmark</cop><pub>Blackwell Publishing Ltd</pub><pmid>36385701</pmid><doi>10.1111/all.15585</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-9411-8998</orcidid><orcidid>https://orcid.org/0000-0003-2882-4784</orcidid><orcidid>https://orcid.org/0000-0002-4070-9976</orcidid><orcidid>https://orcid.org/0000-0002-5878-1730</orcidid><orcidid>https://orcid.org/0000-0001-9990-1332</orcidid><orcidid>https://orcid.org/0000-0002-7356-7126</orcidid><orcidid>https://orcid.org/0000-0002-4121-481X</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Allergy (Copenhagen), 2023-05, Vol.78 (5), p.1269-1279 |
| issn | 0105-4538 1398-9995 |
| language | eng |
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| source | Wiley-Blackwell Read & Publish Collection |
| subjects | Antihistamines barzolvolimab CDX‐0159 Cell activation Chronic Disease Chronic Inducible Urticaria cold urticaria Disease control Humans Mast cells Mast Cells - pathology Patients Pharmacodynamics Proto-Oncogene Proteins c-kit Provocation tests Quality of Life Receptor mechanisms Skin diseases Skin tests Stem cell factor symptomatic dermographism Tryptase Tryptases Urticaria Urticaria - diagnosis Urticaria - drug therapy |
| title | Anti‐KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria |
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