University of California, Riverside School of Medicine, Riverside, California, U.S.A.
Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, U.S.A.
Laryngoscope. 2022 Dec;132(12):2307-2313. doi: 10.1002/lary.29992. Epub 2021 Dec 16.
Dupilumab was the first biologic approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP). While the risk of adverse events in phase-III clinical trials was low, dupilumab-associated adverse reactions (DAR) with real-world use is unknown and potentially under-reported. We aimed to evaluate DAR for CRSwNP treatment (CRSwNP-tx) using the FDA Adverse Event Reporting System (FAERS).
Retrospective database study.
FAERS was queried for DAR from 2019Q1 to 2021Q2. Individual DAR (iDAR) were categorized and quantitatively compared between treatment groups (CRSwNP, asthma, atopic dermatitis). Zero-truncated Poisson regression was modeled to predict the number of iDAR, and logistic regression was modeled to predict serious DARs.
There were 15,411 DAR observations; 911 for CRSwNP-tx, of which 121 (13.3%) had serious reactions and 3 died. Common CRSwNP-tx iDAR were dermatologic (13.9%), generalized (13.3%), and injection-site (10.8%) symptoms. The number of CRSwNP-tx iDAR was 2.99 [2.81, 3.17], compared to 3.44 [3.32, 3.56] for asthma and 3.18 [3.13, 3.24] for atopic dermatitis (Kruskal-Wallis test, P < .001). For CRSwNP-tx, iDAR reported-risk-ratio was 0.84 [0.77, 0.92] among men and 1.12 [1.04, 1.22] among older adults (>50). Serious DAR reported-odds-ratio was 1.37 [0.91, 2.04] among men and 1.39 [0.93, 2.08] among older adults.
While there are limitations with FAERS, this analysis suggests CRSwNP-tx is associated with fewer iDAR compared with other treatment indications. More iDAR are experienced among women and older adults, but men tend to have more serious DAR.
3 Laryngoscope, 132:2307-2313, 2022.
度普利尤单抗是第一种获批治疗伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）的生物制剂。尽管 III 期临床试验中的不良事件风险较低，但在真实世界应用中，度普利尤单抗相关不良反应（DAR）尚不清楚，且可能报告不足。我们旨在使用 FDA 不良事件报告系统（FAERS）评估 DAR 用于 CRSwNP 治疗（CRSwNP-tx）的情况。
回顾性数据库研究。
在 2019Q1 至 2021Q2 期间，从 FAERS 中查询 DAR。将个体不良事件报告（iDAR）分类，并在治疗组（CRSwNP、哮喘、特应性皮炎）之间进行定量比较。采用零截断泊松回归模型预测 iDAR 的数量，采用逻辑回归模型预测严重 DAR。
共观察到 15411 例 DAR 报告；其中 911 例为 CRSwNP-tx，其中 121 例（13.3%）出现严重反应，3 例死亡。CRSwNP-tx 常见的 iDAR 为皮肤病学（13.9%）、全身性（13.3%）和注射部位（10.8%）症状。与哮喘（3.44 [3.32，3.56]）和特应性皮炎（3.18 [3.13，3.24]）相比，CRSwNP-tx 的 iDAR 数量为 2.99 [2.81，3.17]（Kruskal-Wallis 检验，P<0.001）。在 CRSwNP-tx 中，男性的 iDAR 报告风险比为 0.84 [0.77，0.92]，而老年患者（>50 岁）的 iDAR 报告风险比为 1.12 [1.04，1.22]。男性严重 DAR 的报告比值比为 1.37 [0.91，2.04]，而老年患者的报告比值比为 1.39 [0.93，2.08]。
尽管 FAERS 存在一定的局限性，但该分析表明，与其他治疗适应证相比，CRSwNP-tx 相关的 iDAR 较少。女性和老年患者的 iDAR 更多，但男性更容易出现严重的 DAR。
3 级喉镜，132：2307-2313，2022。
