美国Dupilumab治疗中重度特应性皮炎患者结膜炎和角膜炎的发生率：一项基于医疗保健声明的常规护理队列研究

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-13 DOI:10.1007/s13555-025-01367-5

Jessica M Franklin, Andrea F Marcus, Ihtisham Sultan, Ashley Howell, Sarah-Jo Sinnott, Jeannette Green, Stephen Ezzy, Robert Gately, Rachel E Sobel, Florence T Wang

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引用次数: 0

摘要

在特应性皮炎（AD）患者的临床试验中，dupilumab组结膜炎和角膜炎的发生率高于安慰剂组。使用真实世界数据的研究也显示dupilumab的发病率更高，但没有使用经过验证的算法来确定人群和结果。本研究的目的是在现实世界中，使用经过验证的算法，调查dupilumab治疗的中重度AD患者相对于dupilumab-naïve患者的结膜炎和角膜炎的发生率。方法：在保险索赔数据库中进行回顾性观察队列研究，使用经过验证的算法对中重度AD和眼部结果进行评估。确定dupilumab的起始点，并将倾向评分（PS）与dupilumab-naïve中重度AD患者相匹配。随访期间结膜炎和角膜炎的发病率比（IRRs）和95%可信区间（CIs）采用泊松回归估计。结果：在13790例中重度AD研究人群中，2175例dupilumab启动者和2189例dupilumab-naïve患者被纳入分析。与未接受Dupilumab治疗的中重度AD患者相比，Dupilumab与结膜炎（IRR = 1.86 [95% CI 1.51-2.30]）和角膜炎（IRR = 4.06 [95% CI 1.70-9.68]）的风险增加相关。在dupilumab组和dupilumab-naïve组中，结膜炎的累积1年风险分别为15.8%和8.4%；角膜炎的累积1年风险分别为1.3%和0.2%。结论：研究结果与临床试验和现有文献的安全性数据一致。然而，观察到一些角膜炎事件，事后分析表明残留的混杂因素可能存在。dupilumab的已知获益-风险概况保持不变。

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Incidence of Conjunctivitis and Keratitis Among Individuals with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab in the United States: a Cohort Study in Routine Care Based on Healthcare Claims.

Introduction: In clinical trials of patients with atopic dermatitis (AD), conjunctivitis and keratitis occurred more frequently with dupilumab than placebo. Studies using real-world data have also shown a higher incidence with dupilumab but did not use validated algorithms to identify the population and outcomes. The objective of this study was to investigate the incidence of conjunctivitis and keratitis among patients with moderate-to-severe AD treated with dupilumab relative to dupilumab-naïve patients in a real-world setting using validated algorithms.

Methods: A retrospective observational cohort study was conducted in an insurance claims database using validated algorithms for moderate-to-severe AD and ocular outcomes. Initiators of dupilumab were identified and propensity score (PS) matched with dupilumab-naïve patients with moderate-to-severe AD. Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) for conjunctivitis and keratitis during follow-up were estimated using Poisson regression.

Results: Among 13,790 patients in the moderate-to-severe AD study population, 2175 dupilumab initiators and 2189 dupilumab-naïve patients were included in the analysis. Dupilumab was associated with an increased risk of conjunctivitis (IRR = 1.86 [95% CI 1.51-2.30]) and keratitis (IRR = 4.06 [95% CI 1.70-9.68]) compared to patients with moderate-to-severe AD not receiving dupilumab. The cumulative 1-year risk of conjunctivitis was 15.8% and 8.4% in the dupilumab and dupilumab-naïve cohorts, respectively; the cumulative 1-year risk of keratitis was 1.3% and 0.2%, respectively.

Conclusion: Study findings are consistent with safety data from clinical trials and existing literature. However, a few keratitis events were observed, and post hoc analyses suggested residual confounding might be present. The known benefit-risk profile for dupilumab remains unchanged.

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.