度普利尤单抗对伴重度慢性鼻窦炎伴鼻息肉的嗜酸性中耳炎患者12个月疗效：一项多中心观察性研究

文献信息

中文摘要

背景： 嗜酸性中耳炎（EOM）是一种难治性中耳2型炎症性疾病，常与哮喘及慢性鼻窦炎伴鼻息肉（CRSwNP）相关。常规耳科治疗往往获益不完全或短暂。由于EOM与CRSwNP可能共享涉及鼻腔、咽鼓管和中耳腔的2型炎症通路，生物制剂治疗可能带来超越鼻窦疾病控制的获益。关于度普利尤单抗用于合并EOM与重度CRSwNP患者的长期多中心真实世界数据仍有限。目的：评估度普利尤单抗对成人EOM合并重度CRSwNP患者主观和客观耳科结局的12个月疗效。方法：在这项多中心观察性队列中，48例根据Iino标准诊断的重度CRSwNP合并EOM成人接受度普利尤单抗300 mg每2周一次。耳科结局包括慢性中耳炎结局测试15（COMOT-15；范围0-75）和鼓室压测量。鼻窦结局包括鼻息肉评分、SNOT-22和鼻塞视觉模拟量表，作为次要指标。结局在基线、6个月和12个月时评估。结果：度普利尤单抗与EOM相关结局的进行性改善相关。COMOT-15中位数从基线的49降至6个月的20和12个月的15（P<0.0001）。鼓室压测量从基线的32例B型和16例C型改善为12个月时以A型为主。鼻窦结局也改善：鼻息肉评分中位数从6降至3和2，SNOT-22从68降至28和22，鼻塞VAS从8降至2和1，分别在6个月和12个月时（均P<0.0001）。外周血嗜酸性粒细胞计数未显著下降。结论：在重度CRSwNP合并EOM患者中，度普利尤单抗与EOM相关生活质量和鼓室压测量模式的持续12个月改善相关，支持在“同一气道-同一耳”2型框架内进一步研究。

英文摘要

BackgroundEosinophilic otitis media (EOM) is a refractory type 2 inflammatory disease of the middle ear, frequently associated with asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Conventional otologic treatments often provide incomplete or transient benefit. Because EOM and CRSwNP may share a type 2 inflammatory pathway involving the nasal, Eustachian tube, and middle-ear compartments, biologic therapy may offer benefit beyond sinonasal disease control. Long-term multicenter real-world data on dupilumab in patients with concomitant EOM and severe CRSwNP remain limited.ObjectiveTo evaluate the 12-month effectiveness of dupilumab on subjective and objective otologic outcomes in adults with EOM and severe CRSwNP.MethodsIn this multicenter observational cohort, 48 adults with severe CRSwNP and concomitant EOM, diagnosed according to Iino criteria, received dupilumab 300 mg every 2 weeks. Otologic outcomes included the Chronic Otitis Media Outcome Test 15 (COMOT-15; range 0-75) and tympanometry. Sinonasal outcomes, including Nasal Polyp Score, SNOT-22, and visual analog scale of nasal congestion, were secondary measures. Outcomes were evaluated at baseline, 6 months, and 12 months.ResultsDupilumab was associated with progressive improvement in EOM-related outcomes. Median COMOT-15 decreased from 49 at baseline to 20 at 6 months and 15 at 12 months (P < 0.0001). Tympanometry improved from 32 type B and 16 type C patterns at baseline to predominantly type A patterns at 12 months. Sinonasal outcomes also improved: median NPS decreased from 6 to 3 and 2, SNOT-22 from 68 to 28 and 22, and VAS nasal congestion from 8 to 2 and 1 at 6 and 12 months, respectively (all P < 0.0001). Peripheral eosinophil counts did not significantly decrease.ConclusionIn patients with severe CRSwNP and concomitant EOM, dupilumab was associated with sustained 12-month improvement in EOM-related quality of life and tympanometric patterns, supporting further investigation within a one-airway-one-ear type 2 framework.