Department of Dermatology, Chung-Ang University Hospital, Seoul, South Korea.
Department of Dermatology, Chosun University Hospital, Gwangju, South Korea.
J Dermatol. 2021 Jun;48(6):807-817. doi: 10.1111/1346-8138.15733. Epub 2020 Dec 29.
Psoriasis, a chronic inflammatory skin disease, negatively impacts patients' quality of life (QoL). This randomized, phase III, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of brodalumab, a human anti-interleukin-17 receptor A monoclonal antibody, in Korean patients with moderate to severe plaque psoriasis. Coprimary end-points were the percentage of patients with 75% or more improvement in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (sPGA) success (score 0/1) at week 12. Secondary end-points included the percentage improvement from baseline in PASI score and proportion of patients with PASI 50/75/90/100 responses. QoL was assessed with the Dermatology Life Quality Index (DLQI). Eligible patients were randomized to receive brodalumab 210 mg (N = 40) or placebo (N = 22) every 2 weeks (Q2W) at a 2:1 ratio for 12 weeks. Subsequently, all patients entered an open-label extension phase and received brodalumab 210 mg Q2W until week 62. At week 12, the proportion of patients who achieved the coprimary end-points, PASI 75 and sPGA success, was significantly higher in the brodalumab 210 mg Q2W group compared with the placebo group (92.5% vs 0%). At week 12, the mean ± SD percentage improvement in the PASI score was 96.87 ± 6.01% in the brodalumab 210 mg Q2W group, which was maintained until study end (week 64). PASI 50/75/90 responses were achieved by 100% of patients receiving brodalumab 210 mg Q2W at weeks 6, 13, and 24, respectively; PASI 100 was achieved by 82.8% of patients at week 64. Brodalumab treatment rapidly improved DLQI scores. The most common treatment-emergent adverse events were nasopharyngitis, upper respiratory tract infections, tinea pedis, and urticaria. Overall, treatment with brodalumab 210 mg Q2W resulted in a rapid and significant clinical benefit and was well tolerated in patients with moderate to severe plaque psoriasis in Korea.
银屑病是一种慢性炎症性皮肤病，会降低患者的生活质量（QoL）。这项随机、三期、双盲、安慰剂对照、多中心研究评估了 brodalumab（一种人源抗白细胞介素-17 受体 A 单克隆抗体）在韩国中重度斑块状银屑病患者中的疗效和安全性。主要终点是第 12 周时达到银屑病面积和严重程度指数（PASI 75）改善 75%或更多的患者比例（PASI 75）和静态医生整体评估（sPGA）成功（评分 0/1）。次要终点包括 PASI 评分从基线的改善百分比和 PASI 50/75/90/100 反应的患者比例。生活质量用皮肤病生活质量指数（DLQI）评估。符合条件的患者按 2:1 的比例随机接受 brodalumab 210mg（N=40）或安慰剂（N=22），每 2 周（Q2W）一次，共 12 周。随后，所有患者进入开放标签扩展阶段，并接受 brodalumab 210mg Q2W 治疗，直至第 62 周。第 12 周时，接受 brodalumab 210mg Q2W 治疗的患者达到主要终点（PASI 75 和 sPGA 成功）的比例显著高于安慰剂组（92.5% vs 0%）。第 12 周时，brodalumab 210mg Q2W 组 PASI 评分的平均（±标准差）改善百分比为 96.87±6.01%，直至研究结束（第 64 周）。接受 brodalumab 210mg Q2W 治疗的患者分别在第 6、13 和 24 周时实现 PASI 50/75/90 应答的比例为 100%，第 64 周时实现 PASI 100 应答的比例为 82.8%。brodalumab 治疗迅速改善了 DLQI 评分。最常见的治疗相关不良事件是鼻咽炎、上呼吸道感染、足癣和荨麻疹。总体而言，在韩国中重度斑块状银屑病患者中，brodalumab 210mg Q2W 治疗可迅速显著改善临床疗效，且耐受性良好。
