Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial

<p>Prior exposure to systemic treatments may affect treatment outcomes in moderate-to-severe atopic dermatitis (AD).</p> <p>This study aimed to explore the efficacy and safety of Ivarmacitinib (SHR0302) in moderate-to-severe AD patients with or without previous systemic treatments....

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Huvudupphovsman: Qingchun Diao (5751701) (author)
Övriga upphovsmän: Ruiling Jia (22654733) (author), Min Li (12799) (author), Peng Zhao (128233) (author), Fang Lu (45632) (author), Qin Zhang (58638) (author), Chunzhu Ning (22680917) (author), Juan Long (4017317) (author), Jiajia Li (184267) (author), Yan Huang (46805) (author), Yuyi Wang (462133) (author)
Publicerad: 2025
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author Qingchun Diao (5751701)
author2 Ruiling Jia (22654733)
Min Li (12799)
Peng Zhao (128233)
Fang Lu (45632)
Qin Zhang (58638)
Chunzhu Ning (22680917)
Juan Long (4017317)
Jiajia Li (184267)
Yan Huang (46805)
Yuyi Wang (462133)
author2_role author
author
author
author
author
author
author
author
author
author
author_facet Qingchun Diao (5751701)
Ruiling Jia (22654733)
Min Li (12799)
Peng Zhao (128233)
Fang Lu (45632)
Qin Zhang (58638)
Chunzhu Ning (22680917)
Juan Long (4017317)
Jiajia Li (184267)
Yan Huang (46805)
Yuyi Wang (462133)
author_role author
dc.creator.none.fl_str_mv Qingchun Diao (5751701)
Ruiling Jia (22654733)
Min Li (12799)
Peng Zhao (128233)
Fang Lu (45632)
Qin Zhang (58638)
Chunzhu Ning (22680917)
Juan Long (4017317)
Jiajia Li (184267)
Yan Huang (46805)
Yuyi Wang (462133)
dc.date.none.fl_str_mv 2025-11-25T11:00:05Z
dc.identifier.none.fl_str_mv 10.6084/m9.figshare.30705032.v1
dc.relation.none.fl_str_mv https://figshare.com/articles/dataset/Efficacy_and_safety_of_Ivarmacitinib_in_moderate-to-severe_atopic_dermatitis_patients_with_or_without_previous_systemic_treatments_a_post-hoc_analysis_of_a_phase_III_trial/30705032
dc.rights.none.fl_str_mv CC BY 4.0
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv Medicine
Pharmacology
Biotechnology
Science Policy
Biological Sciences not elsewhere classified
Ivarmacitinib
moderate-to-severe atopic dermatitis
previous systemic treatments
efficacy
safety
dc.title.none.fl_str_mv Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
dc.type.none.fl_str_mv Dataset
info:eu-repo/semantics/publishedVersion
dataset
description <p>Prior exposure to systemic treatments may affect treatment outcomes in moderate-to-severe atopic dermatitis (AD).</p> <p>This study aimed to explore the efficacy and safety of Ivarmacitinib (SHR0302) in moderate-to-severe AD patients with or without previous systemic treatments.</p> <p>This was a post-hoc analysis of a phase III clinical trial of Ivarmacitinib in moderate-to-severe AD (NCT04875169). Subgroup analysis by with (<i>N</i> = 132) or without (<i>N</i> = 204) previous systemic treatments (systemic corticosteroids, biologics, or other immunomodulators) was performed.</p> <p>In patients with previous systemic treatments, Ivarmacitinib 8 mg (<i>n</i> = 34) and 4 mg (<i>n</i> = 53) exhibited higher Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI)-75, EASI-90, and Worst Itch Numeric Rating Scale (WI-NRS) 4 response rates, and a greater reduction in Dermatology Life Quality Index (DLQI) score compared with placebo (<i>n</i> = 45) at most timepoints from W4 to W16. In patients without previous systemic treatments, these outcomes were notably increased in Ivarmacitinib 8 mg (<i>n</i> = 78) and 4 mg (<i>n</i> = 60) versus placebo (<i>n</i> = 66) throughout W4 to W16. The adverse events were generally comparable between Ivarmacitinib and placebo groups, regardless of previous systemic treatments.</p> <p>Ivarmacitinib demonstrates good efficacy and a favorable safety profile in moderate-to-severe AD patients, irrespective of previous systemic treatments.</p>
eu_rights_str_mv openAccess
id Manara_0652a0907d5486a47800573c2e8e9aa9
identifier_str_mv 10.6084/m9.figshare.30705032.v1
network_acronym_str Manara
network_name_str ManaraRepo
oai_identifier_str oai:figshare.com:article/30705032
publishDate 2025
repository.mail.fl_str_mv
repository.name.fl_str_mv
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rights_invalid_str_mv CC BY 4.0
spelling Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trialQingchun Diao (5751701)Ruiling Jia (22654733)Min Li (12799)Peng Zhao (128233)Fang Lu (45632)Qin Zhang (58638)Chunzhu Ning (22680917)Juan Long (4017317)Jiajia Li (184267)Yan Huang (46805)Yuyi Wang (462133)MedicinePharmacologyBiotechnologyScience PolicyBiological Sciences not elsewhere classifiedIvarmacitinibmoderate-to-severe atopic dermatitisprevious systemic treatmentsefficacysafety<p>Prior exposure to systemic treatments may affect treatment outcomes in moderate-to-severe atopic dermatitis (AD).</p> <p>This study aimed to explore the efficacy and safety of Ivarmacitinib (SHR0302) in moderate-to-severe AD patients with or without previous systemic treatments.</p> <p>This was a post-hoc analysis of a phase III clinical trial of Ivarmacitinib in moderate-to-severe AD (NCT04875169). Subgroup analysis by with (<i>N</i> = 132) or without (<i>N</i> = 204) previous systemic treatments (systemic corticosteroids, biologics, or other immunomodulators) was performed.</p> <p>In patients with previous systemic treatments, Ivarmacitinib 8 mg (<i>n</i> = 34) and 4 mg (<i>n</i> = 53) exhibited higher Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI)-75, EASI-90, and Worst Itch Numeric Rating Scale (WI-NRS) 4 response rates, and a greater reduction in Dermatology Life Quality Index (DLQI) score compared with placebo (<i>n</i> = 45) at most timepoints from W4 to W16. In patients without previous systemic treatments, these outcomes were notably increased in Ivarmacitinib 8 mg (<i>n</i> = 78) and 4 mg (<i>n</i> = 60) versus placebo (<i>n</i> = 66) throughout W4 to W16. The adverse events were generally comparable between Ivarmacitinib and placebo groups, regardless of previous systemic treatments.</p> <p>Ivarmacitinib demonstrates good efficacy and a favorable safety profile in moderate-to-severe AD patients, irrespective of previous systemic treatments.</p>2025-11-25T11:00:05ZDatasetinfo:eu-repo/semantics/publishedVersiondataset10.6084/m9.figshare.30705032.v1https://figshare.com/articles/dataset/Efficacy_and_safety_of_Ivarmacitinib_in_moderate-to-severe_atopic_dermatitis_patients_with_or_without_previous_systemic_treatments_a_post-hoc_analysis_of_a_phase_III_trial/30705032CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/307050322025-11-25T11:00:05Z
spellingShingle Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
Qingchun Diao (5751701)
Medicine
Pharmacology
Biotechnology
Science Policy
Biological Sciences not elsewhere classified
Ivarmacitinib
moderate-to-severe atopic dermatitis
previous systemic treatments
efficacy
safety
status_str publishedVersion
title Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
title_full Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
title_fullStr Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
title_full_unstemmed Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
title_short Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
title_sort Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial
topic Medicine
Pharmacology
Biotechnology
Science Policy
Biological Sciences not elsewhere classified
Ivarmacitinib
moderate-to-severe atopic dermatitis
previous systemic treatments
efficacy
safety