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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Autore principale: Qingchun Diao (5751701) (author)
Altri autori: 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)
Pubblicazione: 2025
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Riassunto:<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>