Central Dermatology, St. Louis, Missouri.
Innovaderm Research Inc, Montreal, Quebec, Canada; Medical University of Graz, Graz, Austria.
J Am Acad Dermatol. 2018 Nov;79(5):824-830.e2. doi: 10.1016/j.jaad.2018.05.032. Epub 2018 May 25.
Psoriasis is a chronic disease that may require long-term treatment. Ixekizumab (IXE), which is a high-affinity monoclonal antibody that selectively targets interleukin 17A, is an approved therapy for patients with moderate-to-severe plaque psoriasis.
To evaluate the efficacy and safety of IXE through 156 weeks from the UNCOVER-3 study in patients who were treated with the recommended dose regimen (160 mg of IXE at week 0, 80 mg every 2 weeks up to week 12, and 80 mg every 4 weeks thereafter).
Patients randomized to IXE every 2 weeks, IXE every 4 weeks, etanercept twice weekly, or placebo were switched to IXE every 4 weeks during the long-term extension period. Efficacy data were summarized by using the as-observed, multiple imputation, and modified nonresponder imputation methods.
At week 156, 80.5% of patients had achieved at least a 75% improvement from baseline in their Psoriasis Area Severity Index (PASI) score, 66.0% had achived at least a 90% improvement from baseline in their PASI score, and 45.1% had achieved a 100% improvement from baseline in their PASI score with use of the modified nonresponder imputation method, and 97.2% and 86.2% of patients had achived at least a 75% improvement from baseline in their PASI score with use of the as-observed and multiple imputation methods, respectively. Similar response rates were observed in patients with baseline scalp, nail, or palmoplantar involvement. No new safety signals were identified through year 3.
No placebo or active comparison after week 12.
IXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3 years.
银屑病是一种慢性疾病，可能需要长期治疗。依奇珠单抗（IXE）是一种高亲和力的单克隆抗体，可选择性靶向白细胞介素 17A，是一种批准用于中重度斑块型银屑病患者的治疗药物。
评估在 UNCOVER-3 研究中，患者接受推荐剂量方案（第 0 周给予 160mg IXE，第 12 周前每 2 周给予 80mg，之后每 4 周给予 80mg）治疗 156 周后的 IXE 的疗效和安全性。
每 2 周接受 IXE、每 4 周接受 IXE、依那西普每周 2 次或安慰剂治疗的患者在长期扩展期内转换为每 4 周接受 IXE 治疗。使用观测值、多重插补和改良非应答插补方法汇总疗效数据。
在第 156 周时，80.5%的患者达到了至少 75%的银屑病面积严重程度指数（PASI）评分改善，66.0%的患者达到了至少 90%的 PASI 评分改善，45.1%的患者达到了至少 100%的 PASI 评分改善，使用改良非应答插补法，97.2%和 86.2%的患者使用观测值和多重插补法达到了至少 75%的 PASI 评分改善。在基线时头皮、指甲或掌跖受累的患者中观察到相似的反应率。在第 3 年没有发现新的安全性信号。
第 12 周后无安慰剂或活性对照。
IXE 在 3 年内持续保持高反应，清除皮肤和指甲病变，无新的安全性担忧。
