Background

Dupilumab is an effective treatment for moderate to severe atopic dermatitis (AD) with limited safety data in clinical practice.

Objective

To assess the 6-month risk of conjunctivitis and serious infections in patients with AD who initiated dupilumab.

Methods

In a cohort study using US claims data, we compared the risk of conjunctivitis and serious infections in patients with AD who initiated either dupilumab, methotrexate (MTX), cyclosporine, or mycophenolate. Relative risks (RRs) were computed after 1:1 propensity score matching.

Results

We identified 1775 dupilumab, 1034 MTX, 186 cyclosporine, and 257 mycophenolate users. The 6-month risk for any conjunctivitis was 6.5% for dupilumab, 3.3% for MTX, 4.8% for cyclosporine, and 1.2% for mycophenolate initiators. After PS matching, the RR of any conjunctivitis was increased in dupilumab users versus MTX (RR, 2.45; 95% confidence interval [CI], 1.47-4.08), versus cyclosporine (RR, 1.56; 95% CI, 0.69-3.50), and versus mycophenolate (RR, 7.00; 95% CI, 2.12-23.2). The risk of serious infection was 0.6% in dupilumab and 1.0% in MTX initiators (RR, 0.90; 95% CI, 0.37-2.20).

Limitations

Analyses were based on few events, and differential surveillance is a concern.

Conclusions

Although dupilumab shows a low risk of serious infections, it is associated with a clinically meaningful increase in conjunctivitis that needs to be managed in practice.

中文翻译：

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Dupilumab 与特应性皮炎患者结膜炎和严重感染的风险：倾向评分匹配的队列研究

背景

Dupilumab 是治疗中度至重度特应性皮炎 (AD) 的有效方法，但在临床实践中的安全性数据有限。

客观的

评估开始 dupilumab 的 AD 患者 6 个月结膜炎和严重感染的风险。

方法

在一项使用美国索赔数据的队列研究中，我们比较了开始使用 dupilumab、甲氨蝶呤 (MTX)、环孢素或霉酚酸酯的 AD 患者发生结膜炎和严重感染的风险。在 1:1 倾向评分匹配后计算相对风险 (RR)。

结果

我们确定了 1775 名 dupilumab、1034 名 MTX、186 名环孢菌素和 257 名霉酚酸酯使用者。任何结膜炎的 6 个月风险，dupilumab 为 6.5%，MTX 为 3.3%，环孢素为 4.8%，霉酚酸酯引发剂为 1.2%。PS匹配后，dupilumab使用者与MTX相比，任何结膜炎的RR增加（RR，2.45；95%置信区间[CI]，1.47-4.08），与环孢素（RR，1.56；95% CI，0.69-3.50）相比，和与霉酚酸酯相比（RR，7.00；95% CI，2.12-23.2）。严重感染的风险在 dupilumab 中为 0.6%，在 MTX 起始剂中为 1.0%（RR，0.90；95% CI，0.37-2.20）。

限制

分析基于少数事件，差异监测是一个问题。

结论

尽管 dupilumab 显示出严重感染的低风险，但它与需要在实践中管理的具有临床意义的结膜炎增加有关。