Okubo Yukari, Morita Akimichi, Imafuku Shinichi, Tada Yayoi, Tsuritani Katsuki, Shao Yanqiu, Popmihajlov Zoran, Napoli Andrew, Hippeli Lauren, Habiro Katsuyoshi, Ohtsuki Mamitaro
Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
J Dermatol. 2025 Jun;52(6):953-966. doi: 10.1111/1346-8138.17744. Epub 2025 Apr 30.
Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in Japan for adults with plaque, generalized pustular, and erythrodermic psoriasis who have inadequate response to conventional systemic therapies. In the Phase 3, open-label POETYK PSO-4 (NCT03924427) trial, deucravacitinib was efficacious and well tolerated in Japanese patients with moderate to severe plaque psoriasis. This post hoc analysis of PSO-4 evaluated deucravacitinib efficacy and safety in greater detail in this patient population. Absolute Psoriasis Area and Severity Index (PASI), achievement of PASI thresholds of ≤ 1, ≤ 2, and ≤ 5, and PASI body region (head, trunk, upper limbs, lower limbs) and plaque characteristic (erythema, induration, desquamation) scores were evaluated over 52 weeks. Response rates (PASI 75, PASI 90, and static Physician Global Assessment score of 0 [clear] or 1 [almost clear]) were evaluated based on prior use of systemic (biologic and nonbiologic) therapy and phototherapy. Efficacy was also evaluated in patients with scalp, fingernail, and palmoplantar psoriasis. Select safety events were reviewed. Deucravacitinib improved absolute PASI from Week 1, with improvements maintained through Week 52. Deucravacitinib-treated patients achieved clinically meaningful improvements in PASI thresholds, with nearly half (47.6%) achieving PASI ≤ 1 at Week 52. Deucravacitinib also improved PASI body region and plaque characteristic scores, with improvements that occurred as early as Week 1 maintained through Week 52. Deucravacitinib was efficacious through Week 52 regardless of prior use of systemic therapy or phototherapy. Deucravacitinib was also efficacious in patients with scalp and fingernail psoriasis, and in the limited number with palmoplantar psoriasis. Serious adverse events, adverse events resulting in discontinuation, and shifts to Grade ≥ 3 laboratory abnormalities were rare over 52 weeks. This analysis provides a more detailed characterization of Japanese patients with plaque psoriasis appropriate for deucravacitinib treatment and confirms that deucravacitinib is efficacious and well tolerated in this patient population. Trial Registration: www.ClinicalTrials.gov identifier: NCT03924427.
氘可来昔替尼是一种口服、选择性、变构酪氨酸激酶2抑制剂,在日本被批准用于对传统全身治疗反应不足的斑块状、泛发性脓疱型和红皮病型银屑病成人患者。在3期开放标签POETYK PSO-4(NCT03924427)试验中,氘可来昔替尼在中度至重度斑块状银屑病日本患者中疗效显著且耐受性良好。这项PSO-4的事后分析更详细地评估了氘可来昔替尼在该患者群体中的疗效和安全性。在52周内评估了绝对银屑病面积和严重程度指数(PASI)、PASI阈值≤1、≤2和≤5的达成情况,以及PASI身体区域(头部、躯干、上肢、下肢)和斑块特征(红斑、硬结、脱屑)评分。根据先前全身(生物和非生物)治疗及光疗的使用情况评估缓解率(PASI 75、PASI 90以及静态医师整体评估评分为0[清除]或1[几乎清除])。还评估了头皮、指甲和掌跖银屑病患者的疗效。对特定安全事件进行了审查。氘可来昔替尼从第1周起改善绝对PASI,并在第52周维持改善效果。接受氘可来昔替尼治疗的患者在PASI阈值方面取得了具有临床意义的改善,在第52周时近一半(47.6%)患者实现PASI≤1。氘可来昔替尼还改善了PASI身体区域和斑块特征评分,改善最早在第1周出现并维持至第52周。无论先前是否使用全身治疗或光疗,氘可来昔替尼在第52周时均疗效显著。氘可来昔替尼对头皮和指甲银屑病患者以及数量有限的掌跖银屑病患者也有效。在52周内,严重不良事件、导致停药的不良事件以及转为≥3级实验室异常的情况很少见。该分析对适合氘可来昔替尼治疗的日本斑块状银屑病患者进行了更详细的特征描述,并证实氘可来昔替尼在该患者群体中疗效显著且耐受性良好。试验注册:www.ClinicalTrials.gov标识符:NCT03924427。