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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
Main Authors: Schmid‐Grendelmeier, Peter, Gooderham, Melinda J., Hartmann, Karin, Konstantinou, George N., Fellmann, Marc, Koulias, Christopher, Clibborn, Claire, Biswas, Pinaki, Brunner, Patrick M.
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container_title Allergy (Copenhagen)
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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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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 (&lt;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%; &gt;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 &amp; Sons Ltd.</rights><rights>2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley &amp; 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 (&lt;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%; &gt;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. 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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 (&lt;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%; &gt;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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