Department of Dermatology, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan.
Exp Dermatol. 2024 Nov;33(11):e70010. doi: 10.1111/exd.70010.
Dupilumab, an anti-interleukin (IL)-4 receptor α-antibody, was approved in 2018 for the treatment of moderate-to-severe atopic dermatitis (AD) in Japan. Although real-world data have accumulated on the effectiveness and safety of dupilumab in patients with AD in the short term, real-world data on its long-term use are limited. In this study, we retrospectively investigated its effectiveness, safety and laboratory data in patients with AD who received dupilumab for 3 years. All adult patients with moderate-to-severe AD who were administered dupilumab between June 2018 and December 2020 and were treated with dupilumab for more than 3 years were included in this study. Sixty Japanese patients with AD (male, 48; female, 12) were included in this study. Their mean age was 36.6 ± 11.0 (standard deviation) years. The mean Eczema Area and Severity Index (EASI) was 29.9 ± 9.2. The clinical severity scales, including Investigator's Global Assessment (IGA), EASI and affected body surface area (BSA), and patient-reported outcomes, such as Dermatology Quality Life Index (DLQI), Patient-Oriented Eczema Measure (POEM) and visual analogue scale (VAS) of pruritus, significantly improved at 3 months, and at 1, 2 and 3 years after initiating dupilumab. The total EASI score significantly decreased by a mean of 66.8% at 3 months, 81.0% at 1 year, 85.3% at 2 years and 90.0% at 3 years after initiating dupilumab. The serum levels of thymus and activation-regulated chemokine (TARC), immunoglobulin E (IgE) and lactate dehydrogenase (LDH) significantly decreased at 1, 2 and 3 years. A slight decrease in circulating neutrophils was observed in patients with AD treated with dupilumab over periods from 3 months to 3 years. The number of circulating eosinophils significantly decreased at 2 and 3 years after initiating dupilumab. The most common adverse event was ocular disorders observed in 23 patients (38.3%). Our study shows the sustained effectiveness and tolerable safety of 3-year usage of dupilumab in Japanese patients with atopic dermatitis. Furthermore, dupilumab decreased neutrophil values at 3 months and later, and reduced the number of circulating eosinophils after long-term use (≧ 2 years).
度普利尤单抗是一种抗白细胞介素（IL）-4 受体α抗体，于 2018 年在日本获批用于治疗中重度特应性皮炎（AD）。尽管已有短期内在 AD 患者中应用度普利尤单抗的有效性和安全性的真实世界数据，但长期应用的数据有限。在这项研究中，我们回顾性调查了在接受度普利尤单抗治疗 3 年的 AD 患者中，该药的有效性、安全性和实验室数据。所有在 2018 年 6 月至 2020 年 12 月期间接受度普利尤单抗治疗且治疗时间超过 3 年的中重度 AD 成年患者均被纳入本研究。该研究共纳入 60 例 AD 患者（男 48 例，女 12 例）。他们的平均年龄为 36.6±11.0（标准差）岁。平均湿疹面积和严重程度指数（EASI）为 29.9±9.2。临床严重程度评分，包括研究者全球评估（IGA）、EASI 和受累体表面积（BSA），以及患者报告的结局，如皮肤病生活质量指数（DLQI）、患者导向湿疹测量（POEM）和瘙痒视觉模拟量表（VAS），在 3 个月时、起始度普利尤单抗后 1、2 和 3 年时显著改善。总 EASI 评分在 3 个月时平均下降 66.8%，在 1 年时下降 81.0%，在 2 年时下降 85.3%，在 3 年时下降 90.0%。起始度普利尤单抗后 1、2 和 3 年时，血清胸腺和激活调节趋化因子（TARC）、免疫球蛋白 E（IgE）和乳酸脱氢酶（LDH）水平显著降低。AD 患者在接受度普利尤单抗治疗的 3 个月至 3 年内，循环中性粒细胞略有下降。起始度普利尤单抗后 2 和 3 年，循环嗜酸性粒细胞数量显著减少。最常见的不良事件是 23 例（38.3%）患者出现的眼部疾病。本研究表明，在日本特应性皮炎患者中，度普利尤单抗的 3 年使用具有持续的有效性和可耐受的安全性。此外，度普利尤单抗在 3 个月及以后降低了中性粒细胞值，并在长期（≥2 年）使用后减少了循环嗜酸性粒细胞的数量。
