Background

Psoriasis affects 0.13%-2.1% of children and adolescents. Despite a high unmet need, the current treatment options approved for pediatric psoriasis are limited.

Objective

To evaluate the efficacy and safety of 2 secukinumab dosage regimens (low dose: 75/75/150 mg; high dose: 75/150/300 mg) stratified and randomized by weight (<25 kg, 25 to <50 kg, ≥50 kg) and disease severity (moderate, severe) in pediatric patients aged 6-<18 years with moderate to severe plaque psoriasis.

Methods

This is a phase 3, open-label, randomized, multicenter study (NCT03668613).

Results

Both secukinumab doses were superior to historical placebo with respect to psoriasis area and severity index (PASI)-75/90 and investigator global assessment 0/1 responses at week 12. The estimated probability of a positive treatment effect (ie, log odds ratio > 0) for low- or high-dose secukinumab compared to historical placebo is 1 (ie, 100%). For the low and high doses at week 12, the investigator global assessment 0/1 response rates were 78.6% and 83.3%, respectively, and the PASI-90 response rates were 69% and 76.2%, respectively. The PASI-75 response rate was 92.9% for both the doses.

Limitations

This is an open-label study design without a control arm.

Conclusion

Secukinumab dosing regimens were efficacious and well tolerated in pediatric patients with moderate to severe plaque psoriasis.

中文翻译：

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一项 3 期开放标签、随机多中心研究，以评估苏金单抗在中度至重度斑块型银屑病儿科患者中的疗效和安全性：24 周结果

背景

银屑病影响 0.13%-2.1% 的儿童和青少年。尽管有很高的未满足需求，但目前批准用于小儿银屑病的治疗选择有限。

客观的

评估 2 种苏金单抗给药方案（低剂量：75/75/150 mg；高剂量：75/150/300 mg）按体重（<25 kg，25 至 <50 kg，≥50 kg) 和疾病严重程度（中度、重度）在 6-<18 岁患有中度至重度斑块型银屑病的儿科患者中。

方法

这是一项 3 期、开放标签、随机、多中心研究 (NCT03668613)。

结果

在银屑病面积和严重程度指数 (PASI)-75/90 和研究者在第 12 周时的总体评估为 0/1 响应方面，两种苏金单抗剂量均优于历史安慰剂。估计的阳性治疗效果概率（即对数优势比 > 0) 与历史安慰剂相比，低或高剂量苏金单抗为 1（即 100%）。对于第 12 周的低剂量和高剂量，研究者全局评估 0/1 反应率分别为 78.6% 和 83.3%，PASI-90 反应率分别为 69% 和 76.2%。两种剂量的 PASI-75 反应率为 92.9%。

限制

这是一项没有控制臂的开放标签研究设计。

结论

苏金单抗给药方案对中度至重度斑块型银屑病儿科患者有效且耐受性良好。