Background

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.

Objective

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).

Methods

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.

Results

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.

Limitations

No placebo or active comparison after week 12.

Conclusion

IXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3 years.

中文翻译：

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依克珠单抗治疗牛皮癣可维持皮肤清除：UNCOVER-3研究的三年结果

背景

牛皮癣是一种慢性疾病，可能需要长期治疗。Ixekizumab（IXE）是一种选择性针对白介素17A的高亲和力单克隆抗体，已被批准用于中度至重度斑块状牛皮癣患者的治疗。

客观的

为了评估UNCOVER-3研究中156周后IXE的有效性和安全性，该患者接受了推荐剂量方案的治疗（0周时IXE为160 mg，第12周时每2周为80 mg，第12周时为80 mg此后4周）。

方法

在长期延长期内，患者每2周随机分组接受IXE，每4周随机分组接受IXE，每周两次接受etanercept或安慰剂，每4周随机分组接受IXE。通过使用观察，多重插补和修改的无响应插补方法总结了疗效数据。

结果

在第156周时，牛皮癣区域严重程度指数（PASI）得分比基线提高了至少75％，百分之80.5％的患者PASI得分比基线提高了至少90％，45.1％的患者达到了基线。使用改良的无反应者插补方法，PASI得分比基线提高了100％，使用观察和观察到的患者，PASI得分比基线至少提高了77.2％和86.2％分别采用多种插补方法。在基线头皮，指甲或掌plant受累的患者中观察到相似的缓解率。直到第3年都没有发现新的安全信号。

局限性

第12周后无安慰剂或积极比较。

结论

IXE在清除皮肤和指甲病变方面一直保持高响应，并且在3年内没有新的安全隐患。