Blauvelt Andrew, Boguniewicz Mark, Brunner Patrick M, Luna Paula C, Biswas Pinaki, DiBonaventura Marco, Farooqui Saleem A, Rojo Ricardo, Cameron Michael C
Department of Dermatology, Oregon Medical Research Center, Portland, OR, USA.
Division of Allergy and Immunology, Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver, CO, USA.
J Dermatolog Treat. 2022 Aug;33(5):2605-2613. doi: 10.1080/09546634.2022.2059053. Epub 2022 Jul 6.
Abrocitinib, a once-daily, oral Janus kinase 1 selective inhibitor, was shown to be an effective treatment for moderate-to-severe atopic dermatitis in phase 2 b/3 monotherapy trials.
These analyses included data for Investigator's Global Assessment responder (clear [0] or almost clear [1] with ≥2-grade improvement) and nonresponder patients with moderate-to-severe atopic dermatitis who received abrocitinib (200 mg or 100 mg) or placebo in three abrocitinib monotherapy trials (phase 2 b, NCT02780167; two phase 3, NCT03349060/JADE MONO-1 and NCT03575871/JADE MONO-2). Outcomes measuring skin clearance, itch, and quality of life were evaluated.
Both nonresponders ( = 548) and responders ( = 260) treated with abrocitinib had rapid and clinically meaningful improvement in skin clearance, itch, and quality of life compared with placebo.
Patients with moderate-to-severe atopic dermatitis treated with abrocitinib who did not achieve an Investigator's Global Assessment 0/1 response at week 12 still experienced rapid, clinically meaningful improvements across several other validated measures of efficacy and quality of life.
CLINICALTRIALS.GOV: NCT02780167, NCT03349060, NCT03575871.
阿布昔替尼是一种每日一次的口服 Janus 激酶 1 选择性抑制剂,在 2b/3 期单药治疗试验中显示出对中重度特应性皮炎有效。
这些分析纳入了在三项阿布昔替尼单药治疗试验(2b 期,NCT02780167;两项 3 期,NCT03349060/JADE MONO-1 和 NCT03575871/JADE MONO-2)中接受阿布昔替尼(200mg 或 100mg)或安慰剂治疗的中重度特应性皮炎研究者整体评估应答者(清除 [0] 或几乎清除 [1] 且改善≥2 级)和无应答患者的数据。评估了测量皮肤清除率、瘙痒和生活质量的结果。
与安慰剂相比,接受阿布昔替尼治疗的无应答者(n = 548)和应答者(n = 260)在皮肤清除率、瘙痒和生活质量方面均有快速且具有临床意义的改善。
在 12 周时未达到研究者整体评估 0/1 应答的接受阿布昔替尼治疗的中重度特应性皮炎患者,在其他多项经过验证的疗效和生活质量指标上仍经历了快速且具有临床意义的改善。
NCT02780167、NCT03349060、NCT03575871。