J Drugs Dermatol. 2021 Aug 1;20(8):880-887. doi: 10.36849/JDD.6101.
Long-term efficacy, safety, and quality of life with ixekizumab (IXE) through 5 years in UNCOVER-1 and UNCOVER-2 patients with baseline scalp, nail, or palmoplantar psoriasis were assessed.
Patients included in this intent-to-treat subanalysis had baseline involvement in at least one of the three anatomic areas (scalp, fingernail, or palmoplantar locations) and 1) received IXE through week 60, with a 160-mg starting dose 80 mg Q2W through week 12 and Q4W thereafter, 2) achieved a static Physician’s Global Assessment score of 0 or 1 at week 12, and 3) completed week 60 and continued treatment with IXE Q4W or were escalated to Q2W during the long-term extension. Efficacy outcomes (e.g., percent improvement in Psoriasis Scalp Severity Index [PSSI], Nail Psoriasis Severity Index [NAPSI], Palmoplantar Psoriasis Area and Severity [PPASI], and Dermatology Life Quality Index [DLQI]) were summarized by descriptive statistics through week 264.
Patients rapidly achieved and sustained improvements in scalp, nail, and palmoplantar psoriasis for up to 5 years with IXE. Patients achieved complete clearance at year 5: observed (scalp, 82%; nail, 73%; palmoplantar, 96%) and mNRI (scalp, 77%; nail, 67%; palmoplantar, 85%). Up to 80% of patients reported DLQI 0,1 responses at week 12, which were sustained through week 264. No increases in the number of annual treatment-emergent adverse events were observed from years 1–5.
Patients receiving IXE for 5 years sustained high rates of improvement in scalp, nail, and palmoplantar psoriasis, with a long-term quality of life benefit with no unexpected safety signals. J Drugs Dermatol. 2021;20(8):880-887. doi:10.36849/JDD.6101.
在 UNCOVER-1 和 UNCOVER-2 研究中，评估基线时头皮、指甲或掌跖银屑病患者接受依奇珠单抗（IXE）治疗 5 年的长期疗效、安全性和生活质量。
这项意向治疗亚分析纳入了基线至少有一个以下三个解剖区域（头皮、指甲或掌跖部位）受累的患者：1）接受 IXE 治疗至第 60 周，起始剂量为 160mg，第 12 周及第 12 周后每隔 2 周皮下注射 80mg；2）第 12 周时静态医师整体评估（sPGA）评分达到 0 或 1；3）完成第 60 周并继续接受 IXE 每 4 周 1 次治疗，或在长期扩展期内升级为每 2 周 1 次。通过描述性统计汇总了第 264 周时的疗效结局（例如，头皮银屑病严重指数[PSSI]、指甲银屑病严重指数[NAPSI]、掌跖银屑病面积和严重程度[PPASI]和皮肤病生活质量指数[DLQI]的改善百分比）。
IXE 治疗可使头皮、指甲和掌跖银屑病患者快速且持续改善，最长可达 5 年。患者在第 5 年时达到完全清除：观察到（头皮，82%；指甲，73%；掌跖，96%）和改良的 Nail Psoriasis Severity Index 评分（mNRI）（头皮，77%；指甲，67%；掌跖，85%）。在第 12 周时，高达 80%的患者报告了 DLQI 0/1 应答，且一直持续至第 264 周。从第 1 年到第 5 年，每年新发治疗相关不良事件的数量没有增加。
接受 IXE 治疗 5 年的患者头皮、指甲和掌跖银屑病的改善率保持较高水平，且具有长期的生活质量获益，无意外安全性信号。
