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Efficacy and safety of abrocitinib in patients with moderate‐to‐severe atopic dermatitis and comorbid allergies
Background Abrocitinib efficacy by comorbidity status in patients with moderate‐to‐severe atopic dermatitis (AD) has not been previously assessed. This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with AD and allergic comorbidities. Methods Data were pooled from pat...
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Published in: | Allergy (Copenhagen) 2024-01, Vol.79 (1), p.174-183 |
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creator | Schmid‐Grendelmeier, Peter Gooderham, Melinda J. Hartmann, Karin Konstantinou, George N. Fellmann, Marc Koulias, Christopher Clibborn, Claire Biswas, Pinaki Brunner, Patrick M. |
description | Background
Abrocitinib efficacy by comorbidity status in patients with moderate‐to‐severe atopic dermatitis (AD) has not been previously assessed. This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with AD and allergic comorbidities.
Methods
Data were pooled from patients who received abrocitinib 200 mg, 100 mg, or placebo in phase 2b (NCT02780167) and phase 3 (NCT03349060, NCT03575871) monotherapy trials. Patients with and without allergic comorbidities (allergic asthma, rhinitis, conjunctivitis, or food allergy) were evaluated for Investigator's Global Assessment (IGA) response (clear [0] or almost clear [1]), ≥75% improvement in the Eczema Area and Severity Index (EASI‐75), ≥4‐point improvement in Peak Pruritus Numerical Rating Scale (PP‐NRS4), and Dermatology Life Quality Index (DLQI) response (1 allergic comorbidity, 34%). Regardless of comorbidity status, from Week 2 to Week 12, higher percentages of patients treated with either abrocitinib dose achieved IGA 0/1, EASI‐75, PP‐NRS4, or DLQI 0/1 versus placebo‐treated patients. Changes from baseline in POEM, SCORAD, and PSAAD were greater with abrocitinib than with placebo in patients with and without allergic comorbidities. Most TEAEs were mild or moderate.
Conclusions
Efficacy and safety data support abrocitinib use to manage AD in patients with or without allergic comorbidities.
In this pool of patients with moderate‐to‐severe AD, 53% reported at least one allergic comorbidity (asthma, conjunctivitis, rhinitis, or food allergies). Abrocitinib 200 mg or 100 mg monotherapy improved clinical, patient‐reported, and HRQoL outcomes versus placebo, regardless of patients' allergic comorbidities. In patients with moderate‐to‐severe AD, abrocitinib is efficacious and well tolerated in those with or without allergic comorbidities. |
doi_str_mv | 10.1111/all.15952 |
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Abrocitinib efficacy by comorbidity status in patients with moderate‐to‐severe atopic dermatitis (AD) has not been previously assessed. This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with AD and allergic comorbidities.
Methods
Data were pooled from patients who received abrocitinib 200 mg, 100 mg, or placebo in phase 2b (NCT02780167) and phase 3 (NCT03349060, NCT03575871) monotherapy trials. Patients with and without allergic comorbidities (allergic asthma, rhinitis, conjunctivitis, or food allergy) were evaluated for Investigator's Global Assessment (IGA) response (clear [0] or almost clear [1]), ≥75% improvement in the Eczema Area and Severity Index (EASI‐75), ≥4‐point improvement in Peak Pruritus Numerical Rating Scale (PP‐NRS4), and Dermatology Life Quality Index (DLQI) response (<2 with baseline score ≥2). Other outcomes were Patient‐Oriented Eczema Measure (POEM), SCORing Atopic Dermatitis (SCORAD), Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD), and treatment‐emergent adverse events (TEAEs).
Results
Of 942 patients, 498 (53%) reported at least one allergic comorbidity (asthma only, 33%; conjunctivitis only or rhinitis only or both, 17%; food allergies only, 15%; >1 allergic comorbidity, 34%). Regardless of comorbidity status, from Week 2 to Week 12, higher percentages of patients treated with either abrocitinib dose achieved IGA 0/1, EASI‐75, PP‐NRS4, or DLQI 0/1 versus placebo‐treated patients. Changes from baseline in POEM, SCORAD, and PSAAD were greater with abrocitinib than with placebo in patients with and without allergic comorbidities. Most TEAEs were mild or moderate.
Conclusions
Efficacy and safety data support abrocitinib use to manage AD in patients with or without allergic comorbidities.
In this pool of patients with moderate‐to‐severe AD, 53% reported at least one allergic comorbidity (asthma, conjunctivitis, rhinitis, or food allergies). Abrocitinib 200 mg or 100 mg monotherapy improved clinical, patient‐reported, and HRQoL outcomes versus placebo, regardless of patients' allergic comorbidities. In patients with moderate‐to‐severe AD, abrocitinib is efficacious and well tolerated in those with or without allergic comorbidities.</description><identifier>ISSN: 0105-4538</identifier><identifier>ISSN: 1398-9995</identifier><identifier>EISSN: 1398-9995</identifier><identifier>DOI: 10.1111/all.15952</identifier><identifier>PMID: 37988255</identifier><language>eng</language><publisher>Denmark: Blackwell Publishing Ltd</publisher><subject>abrocitinib ; Allergies ; Asthma ; Atopic dermatitis ; Clinical trials ; Comorbidity ; Conjunctivitis ; Dermatitis ; Eczema ; Food allergies ; food allergy ; Immunoglobulin A ; Placebos ; Pruritus ; Quality of life ; Rhinitis ; Safety</subject><ispartof>Allergy (Copenhagen), 2024-01, Vol.79 (1), p.174-183</ispartof><rights>2023 The Authors. published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.</rights><rights>2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.</rights><rights>2023. This article is published under http://creativecommons.org/licenses/by-nc-nd/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-c3882-631bd6a854f2f9c6e39ad3e1385290f1c71e591ee01051dc7e4afd6d9a1738553</citedby><cites>FETCH-LOGICAL-c3882-631bd6a854f2f9c6e39ad3e1385290f1c71e591ee01051dc7e4afd6d9a1738553</cites><orcidid>0000-0003-1371-6764 ; 0000-0002-4595-8226 ; 0000-0003-3215-3370 ; 0000-0001-8926-0113 ; 0000-0002-2586-891X ; 0000-0003-0064-698X ; 0000-0002-3488-3345</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27907,27908</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37988255$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schmid‐Grendelmeier, Peter</creatorcontrib><creatorcontrib>Gooderham, Melinda J.</creatorcontrib><creatorcontrib>Hartmann, Karin</creatorcontrib><creatorcontrib>Konstantinou, George N.</creatorcontrib><creatorcontrib>Fellmann, Marc</creatorcontrib><creatorcontrib>Koulias, Christopher</creatorcontrib><creatorcontrib>Clibborn, Claire</creatorcontrib><creatorcontrib>Biswas, Pinaki</creatorcontrib><creatorcontrib>Brunner, Patrick M.</creatorcontrib><title>Efficacy and safety of abrocitinib in patients with moderate‐to‐severe atopic dermatitis and comorbid allergies</title><title>Allergy (Copenhagen)</title><addtitle>Allergy</addtitle><description>Background
Abrocitinib efficacy by comorbidity status in patients with moderate‐to‐severe atopic dermatitis (AD) has not been previously assessed. This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with AD and allergic comorbidities.
Methods
Data were pooled from patients who received abrocitinib 200 mg, 100 mg, or placebo in phase 2b (NCT02780167) and phase 3 (NCT03349060, NCT03575871) monotherapy trials. Patients with and without allergic comorbidities (allergic asthma, rhinitis, conjunctivitis, or food allergy) were evaluated for Investigator's Global Assessment (IGA) response (clear [0] or almost clear [1]), ≥75% improvement in the Eczema Area and Severity Index (EASI‐75), ≥4‐point improvement in Peak Pruritus Numerical Rating Scale (PP‐NRS4), and Dermatology Life Quality Index (DLQI) response (<2 with baseline score ≥2). Other outcomes were Patient‐Oriented Eczema Measure (POEM), SCORing Atopic Dermatitis (SCORAD), Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD), and treatment‐emergent adverse events (TEAEs).
Results
Of 942 patients, 498 (53%) reported at least one allergic comorbidity (asthma only, 33%; conjunctivitis only or rhinitis only or both, 17%; food allergies only, 15%; >1 allergic comorbidity, 34%). Regardless of comorbidity status, from Week 2 to Week 12, higher percentages of patients treated with either abrocitinib dose achieved IGA 0/1, EASI‐75, PP‐NRS4, or DLQI 0/1 versus placebo‐treated patients. Changes from baseline in POEM, SCORAD, and PSAAD were greater with abrocitinib than with placebo in patients with and without allergic comorbidities. Most TEAEs were mild or moderate.
Conclusions
Efficacy and safety data support abrocitinib use to manage AD in patients with or without allergic comorbidities.
In this pool of patients with moderate‐to‐severe AD, 53% reported at least one allergic comorbidity (asthma, conjunctivitis, rhinitis, or food allergies). Abrocitinib 200 mg or 100 mg monotherapy improved clinical, patient‐reported, and HRQoL outcomes versus placebo, regardless of patients' allergic comorbidities. In patients with moderate‐to‐severe AD, abrocitinib is efficacious and well tolerated in those with or without allergic comorbidities.</description><subject>abrocitinib</subject><subject>Allergies</subject><subject>Asthma</subject><subject>Atopic dermatitis</subject><subject>Clinical trials</subject><subject>Comorbidity</subject><subject>Conjunctivitis</subject><subject>Dermatitis</subject><subject>Eczema</subject><subject>Food allergies</subject><subject>food allergy</subject><subject>Immunoglobulin A</subject><subject>Placebos</subject><subject>Pruritus</subject><subject>Quality of life</subject><subject>Rhinitis</subject><subject>Safety</subject><issn>0105-4538</issn><issn>1398-9995</issn><issn>1398-9995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1kb1OBCEYRYnR6PpT-AKGxEaLcWFYZobSGP-STWy0Jgx8KGZmWIF1s52P4DP6JKK7WphIAQUnh3v5EDqk5IzmNVZdd0a54OUGGlEmmkIIwTfRiFDCiwlnzQ7ajfGZEFKXgmyjHVaLpik5H6F4aa3TSi-xGgyOykJaYm-xaoPXLrnBtdgNeKaSgyFFvHDpCffeQFAJPt7ek89bhFcIgFXyM6dxvusznlz8dmrf-9A6g3NKCI8O4j7asqqLcLA-99DD1eX9xU0xvbu-vTifFprldEXFaGsq1fCJLa3QFTChDAPKGp5bWKprClxQgK-a1OgaJsqayghF68xwtodOVt5Z8C9ziEn2LmroOjWAn0dZNqKsKloTkdHjP-izn4chp5P5rYaQik9Ipk5XlA4-xgBWzoLrVVhKSuTXJGTuKL8nkdmjtXHe9mB-yZ-vz8B4BSxcB8v_TfJ8Ol0pPwGoTpUS</recordid><startdate>202401</startdate><enddate>202401</enddate><creator>Schmid‐Grendelmeier, Peter</creator><creator>Gooderham, Melinda J.</creator><creator>Hartmann, Karin</creator><creator>Konstantinou, George N.</creator><creator>Fellmann, Marc</creator><creator>Koulias, Christopher</creator><creator>Clibborn, Claire</creator><creator>Biswas, Pinaki</creator><creator>Brunner, Patrick M.</creator><general>Blackwell Publishing Ltd</general><scope>24P</scope><scope>WIN</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/0000-0003-1371-6764</orcidid><orcidid>https://orcid.org/0000-0002-4595-8226</orcidid><orcidid>https://orcid.org/0000-0003-3215-3370</orcidid><orcidid>https://orcid.org/0000-0001-8926-0113</orcidid><orcidid>https://orcid.org/0000-0002-2586-891X</orcidid><orcidid>https://orcid.org/0000-0003-0064-698X</orcidid><orcidid>https://orcid.org/0000-0002-3488-3345</orcidid></search><sort><creationdate>202401</creationdate><title>Efficacy and safety of abrocitinib in patients with moderate‐to‐severe atopic dermatitis and comorbid allergies</title><author>Schmid‐Grendelmeier, Peter ; Gooderham, Melinda J. ; Hartmann, Karin ; Konstantinou, George N. ; Fellmann, Marc ; Koulias, Christopher ; Clibborn, Claire ; Biswas, Pinaki ; Brunner, Patrick M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3882-631bd6a854f2f9c6e39ad3e1385290f1c71e591ee01051dc7e4afd6d9a1738553</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>abrocitinib</topic><topic>Allergies</topic><topic>Asthma</topic><topic>Atopic dermatitis</topic><topic>Clinical trials</topic><topic>Comorbidity</topic><topic>Conjunctivitis</topic><topic>Dermatitis</topic><topic>Eczema</topic><topic>Food allergies</topic><topic>food allergy</topic><topic>Immunoglobulin A</topic><topic>Placebos</topic><topic>Pruritus</topic><topic>Quality of life</topic><topic>Rhinitis</topic><topic>Safety</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schmid‐Grendelmeier, Peter</creatorcontrib><creatorcontrib>Gooderham, Melinda J.</creatorcontrib><creatorcontrib>Hartmann, Karin</creatorcontrib><creatorcontrib>Konstantinou, George N.</creatorcontrib><creatorcontrib>Fellmann, Marc</creatorcontrib><creatorcontrib>Koulias, Christopher</creatorcontrib><creatorcontrib>Clibborn, Claire</creatorcontrib><creatorcontrib>Biswas, Pinaki</creatorcontrib><creatorcontrib>Brunner, Patrick M.</creatorcontrib><collection>Wiley-Blackwell Open Access Collection</collection><collection>Wiley Online Library</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>Schmid‐Grendelmeier, Peter</au><au>Gooderham, Melinda J.</au><au>Hartmann, Karin</au><au>Konstantinou, George N.</au><au>Fellmann, Marc</au><au>Koulias, Christopher</au><au>Clibborn, Claire</au><au>Biswas, Pinaki</au><au>Brunner, Patrick M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of abrocitinib in patients with moderate‐to‐severe atopic dermatitis and comorbid allergies</atitle><jtitle>Allergy (Copenhagen)</jtitle><addtitle>Allergy</addtitle><date>2024-01</date><risdate>2024</risdate><volume>79</volume><issue>1</issue><spage>174</spage><epage>183</epage><pages>174-183</pages><issn>0105-4538</issn><issn>1398-9995</issn><eissn>1398-9995</eissn><abstract>Background
Abrocitinib efficacy by comorbidity status in patients with moderate‐to‐severe atopic dermatitis (AD) has not been previously assessed. This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with AD and allergic comorbidities.
Methods
Data were pooled from patients who received abrocitinib 200 mg, 100 mg, or placebo in phase 2b (NCT02780167) and phase 3 (NCT03349060, NCT03575871) monotherapy trials. Patients with and without allergic comorbidities (allergic asthma, rhinitis, conjunctivitis, or food allergy) were evaluated for Investigator's Global Assessment (IGA) response (clear [0] or almost clear [1]), ≥75% improvement in the Eczema Area and Severity Index (EASI‐75), ≥4‐point improvement in Peak Pruritus Numerical Rating Scale (PP‐NRS4), and Dermatology Life Quality Index (DLQI) response (<2 with baseline score ≥2). Other outcomes were Patient‐Oriented Eczema Measure (POEM), SCORing Atopic Dermatitis (SCORAD), Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD), and treatment‐emergent adverse events (TEAEs).
Results
Of 942 patients, 498 (53%) reported at least one allergic comorbidity (asthma only, 33%; conjunctivitis only or rhinitis only or both, 17%; food allergies only, 15%; >1 allergic comorbidity, 34%). Regardless of comorbidity status, from Week 2 to Week 12, higher percentages of patients treated with either abrocitinib dose achieved IGA 0/1, EASI‐75, PP‐NRS4, or DLQI 0/1 versus placebo‐treated patients. Changes from baseline in POEM, SCORAD, and PSAAD were greater with abrocitinib than with placebo in patients with and without allergic comorbidities. Most TEAEs were mild or moderate.
Conclusions
Efficacy and safety data support abrocitinib use to manage AD in patients with or without allergic comorbidities.
In this pool of patients with moderate‐to‐severe AD, 53% reported at least one allergic comorbidity (asthma, conjunctivitis, rhinitis, or food allergies). Abrocitinib 200 mg or 100 mg monotherapy improved clinical, patient‐reported, and HRQoL outcomes versus placebo, regardless of patients' allergic comorbidities. In patients with moderate‐to‐severe AD, abrocitinib is efficacious and well tolerated in those with or without allergic comorbidities.</abstract><cop>Denmark</cop><pub>Blackwell Publishing Ltd</pub><pmid>37988255</pmid><doi>10.1111/all.15952</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-1371-6764</orcidid><orcidid>https://orcid.org/0000-0002-4595-8226</orcidid><orcidid>https://orcid.org/0000-0003-3215-3370</orcidid><orcidid>https://orcid.org/0000-0001-8926-0113</orcidid><orcidid>https://orcid.org/0000-0002-2586-891X</orcidid><orcidid>https://orcid.org/0000-0003-0064-698X</orcidid><orcidid>https://orcid.org/0000-0002-3488-3345</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | abrocitinib Allergies Asthma Atopic dermatitis Clinical trials Comorbidity Conjunctivitis Dermatitis Eczema Food allergies food allergy Immunoglobulin A Placebos Pruritus Quality of life Rhinitis Safety |
title | Efficacy and safety of abrocitinib in patients with moderate‐to‐severe atopic dermatitis and comorbid allergies |
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