Bowyer Kasey, Swisher Austin R, Jiang Nancy, Liang Jonathan
Kaiser Permanente Bernard J. Tyson School of Medicine, Kaiser Permanente, Pasadena, CA, USA.
Department of Otolaryngology-Head and Neck Surgery, Mayo Clinic Arizona, Scottsdale, AZ, USA.
Dis Esophagus. 2025 Jul 3;38(4). doi: 10.1093/dote/doaf055.
Dupilumab, the first biologic approved for eosinophilic esophagitis treatment (EoE-tx) in 2022, demonstrated favorable safety in phase-III clinical trials. However, real-world dupilumab-associated adverse reactions (DARs) for EoE-tx are unknown. This study aims to evaluate DAR for EoE-tx using the FDA Adverse Event Reporting System. FDA Adverse Event Reporting System was queried for DAR between 2022Q1 and 2023Q4. Individual DARs (iDARs) were categorized and compared between treatment groups: EoE, asthma, atopic dermatitis, and chronic rhinosinusitis with nasal polyps. Logistic regression was used to predict serious DAR and outcomes, and zero-truncated negative binomial regression was used to predict the number of iDAR. There were 51,000 DAR observations; 1459 for EoE-tx with 103 (7.1%) serious reactions and 44 (3.0%) serious outcomes including 3 deaths. For EoE-tx, the mean iDAR was 3.68 [3.51, 3.85], and the iDAR incidence rate ratio among men receiving EoE-tx was 0.73 [0.65, 0.83]. EoE-tx average iDAR primarily included general (0.75 [0.70, 0.80]), injection-site (0.69 [0.63, 0.74]), dermatologic (0.51 [0.46, 0.55]), and gastrointestinal (0.24 [0.21, 0.27]) reactions. Adults ≥50 years had 1.97 [1.28, 2.99] higher odds for serious DAR compared to younger adults in EoE-tx. Overall, dupilumab demonstrated a favorable safety profile across all indications, with low rates of serious adverse events. For EoE-tx specifically, higher total iDAR rates were observed, driven largely by increased injection-site and gastrointestinal reactions compared to other indications. Additionally, women exhibited higher iDAR rates than men across all indications.
度普利尤单抗是2022年首个获批用于治疗嗜酸性食管炎（EoE - tx）的生物制剂，在III期临床试验中显示出良好的安全性。然而，EoE - tx在现实世界中与度普利尤单抗相关的不良反应（DARs）尚不清楚。本研究旨在使用美国食品药品监督管理局（FDA）不良事件报告系统评估EoE - tx的DARs。查询FDA不良事件报告系统中2022年第一季度至2023年第四季度期间的DARs。对个体DARs（iDARs）进行分类，并在治疗组之间进行比较：EoE、哮喘、特应性皮炎以及伴有鼻息肉的慢性鼻 - 鼻窦炎。使用逻辑回归预测严重DARs和结果，使用零截断负二项回归预测iDARs的数量。共有51,000条DARs观察数据；EoE - tx有1459条，其中103条（7.1%）为严重反应，44条（3.0%）为严重结果，包括3例死亡。对于EoE - tx，平均iDAR为3.68 [3.51, 3.85]，接受EoE - tx的男性中iDAR发生率比为0.73 [0.65, 0.83]。EoE - tx的平均iDAR主要包括全身性（0.75 [0.70, 0.80]）、注射部位（0.69 [0.63, 0.74]）、皮肤性（0.51 [0.46, 0.55]）和胃肠道（0.24 [0.21, 0.27]）反应。在EoE - tx中，≥50岁的成年人发生严重DAR的几率比年轻成年人高1.97 [1.28, 2.99]。总体而言，度普利尤单抗在所有适应症中均显示出良好的安全性，严重不良事件发生率较低。具体对于EoE - tx，观察到较高的总iDAR率，主要是由于与其他适应症相比，注射部位和胃肠道反应增加。此外，在所有适应症中，女性的iDAR率均高于男性。
