Background

Interleukin 22 promotes epidermal hyperplasia and inhibits skin barrier function.

Objective

Evaluate interleukin 22 blockade in adults with moderate-to-severe atopic dermatitis (AD).

Methods

We performed a randomized, double-blind, placebo-controlled trial with intravenous fezakinumab monotherapy every 2 weeks for 10 weeks, with follow-up assessments until 20 weeks. The change in SCOring AD (SCORAD) score from baseline at 12 weeks served as the primary end point.

Results

At 12 weeks, the mean declines in SCORAD for the entire study population were 13.8 ± 2.7 in the fezakinumab arm and 8.0 ± 3.1 in the placebo arm (P = .134). In the severe AD patient subset (with a baseline SCORAD of ≥50), SCORAD decline was significantly stronger in the drug-treated patients than placebo-treated patients at 12 weeks (21.6 ± 3.8 vs 9.6 ± 4.2, P = .029) and 20 weeks (27.4 ± 3.9 vs 11.5 ± 5.1, P = .010). At 12 weeks, improvements in body surface area involvement in the entire population were significantly stronger in the drug-treated than placebo-treated patients (12.4% ± 2.4 vs 6.2% ± 2.7; P = .009), and in the severe AD subset, the decline in Investigator Global Assessment was significantly higher in the drug-treated than placebo-treated patients (0.7 ± 0.2 vs 0.3 ± 0.1; P = .034). All scores showed progressive improvements after last dosing (10 weeks) until end of study (20 weeks). Common adverse events were upper respiratory tract infections.

Limitations

The limited sample size and lack of assessment with Eczema Area and Severity Index and a pruritus numerical rating scale were limiting factors. Significance was primarily obtained in severe AD.

Conclusion

Fezakinumab was well-tolerated, with sustained clinical improvements after last drug dosing.

中文翻译：

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fezakinumab（一种 IL-22 单克隆抗体）在常规治疗无法充分控制的中重度特应性皮炎成人患者中的疗效和安全性：一项随机、双盲、2a 期试验

背景

白细胞介素22促进表皮增生，抑制皮肤屏障功能。

客观的

评估中度至重度特应性皮炎 (AD) 成人中白细胞介素 22 的阻断作用。

方法

我们进行了一项随机、双盲、安慰剂对照试验，每 2 周进行一次静脉注射 fezakinumab 单药治疗，持续 10 周，随访评估直至 20 周。12 周时 AD 评分 (SCORAD) 评分相对于基线的变化作为主要终点。

结果

在 12 周时，整个研究人群的 SCORAD 平均下降在 fezakinumab 组为 13.8 ± 2.7，在安慰剂组为 8.0 ± 3.1 ( P  = .134)。在重度 AD 患者子集中（基线 SCORAD ≥ 50），在 12 周时，药物治疗患者的 SCORAD 下降明显强于安慰剂治疗患者（21.6 ± 3.8 vs 9.6 ± 4.2，P  = .029）和20 周（27.4 ± 3.9 对 11.5 ± 5.1，P  = .010）。在 12 周时，药物治疗组中整个人群的体表面积改善明显强于安慰剂治疗组（12.4% ± 2.4 vs 6.2% ± 2.7；P = .009），并且在严重的 AD 子集中，接受药物治疗的患者的调查员总体评估下降明显高于接受安慰剂治疗的患者（0.7 ± 0.2 对 0.3 ± 0.1；P  = .034）。从最后一次给药（10 周）到研究结束（20 周），所有分数都显示出逐渐改善。常见的不良事件是上呼吸道感染。

限制

有限的样本量以及缺乏湿疹面积和严重程度指数以及瘙痒数字评定量表的评估是限制因素。显着性主要在严重 AD 中获得。

结论

Fezakinumab 耐受性良好，最后一次给药后临床症状持续改善。