Department of Respiratory Medicine, Allergy and Clinical Immunology, Graduate School of Medical Sciences, Nagoya City University, Aichi, Japan.
Department of Otorhinolaryngology & Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Aichi, Japan.
Ann Allergy Asthma Immunol. 2024 Nov;133(5):550-558.e2. doi: 10.1016/j.anai.2024.07.001. Epub 2024 Jul 6.
Dupilumab exerts clinical effects, including improved sinus opacification, olfactory function, and quality of life, in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNPs). Meanwhile, only a few studies have reported its effects on nasal airway resistance and olfactory function, particularly in the Japanese population. Predictors of response remain unclear.
To assess the comprehensive efficacy and therapeutic response to dupilumab in patients with severe CRSwNP with comorbid asthma.
In 16 adult patients with severe CRSwNP with comorbid asthma, the efficacy of 48-week dupilumab treatment, including olfactory function measured by a T&T olfactometer, nasal airway resistance measured by rhinomanometry, nasal polyp score, Lund-Mackay computed tomography score, and 22-item Sinonasal Outcome Test (SNOT-22), was assessed. Regarding asthma, the annualized rate of exacerbations, 7-item Asthma Control Questionnaire (ACQ-7), and spirometry were assessed. Treatment responsiveness was analyzed.
With 48-week dupilumab treatment, olfactory function, nasal airway resistance, nasal polyp score, Lund-Mackay computed tomography score, and SNOT-22 scores improved significantly. Regarding comorbid asthma, the annualized rate of exacerbations decreased, and ACQ-7 scores and lung function improved significantly. According to the European Position Paper on Rhinosinusitis and Nasal Polyps 2020/European Forum for Research and Education in Allergy and Airway Diseases criteria, 15 patients (94%) were moderate-to-excellent responders at 48 weeks of treatment. Patients with higher SNOT-22 scores, ACQ-7 scores, the rate of asthma exacerbations in the previous year, and blood eosinophil counts benefited more from the treatment.
Dupilumab improved upper and lower airway outcomes especially in patients with severe CRSwNP with comorbid, poorly controlled asthma.
UMIN Clinical Trials Registry: UMIN000038669.
度普利尤单抗可改善严重慢性鼻-鼻窦炎伴鼻息肉（CRSwNPs）患者的鼻窦混浊、嗅觉功能和生活质量，同时，仅有少数研究报告了其对鼻气道阻力和嗅觉功能的影响，特别是在日本人群中。应答的预测因素仍不清楚。
评估度普利尤单抗治疗合并哮喘的严重 CRSwNP 患者的综合疗效和治疗反应。
在 16 例合并哮喘的严重 CRSwNP 成年患者中，评估了 48 周度普利尤单抗治疗的疗效，包括 T&T 嗅觉计测量的嗅觉功能、鼻阻力测量的鼻阻力计、鼻息肉评分、Lund-Mackay 计算机断层扫描评分和 22 项鼻-鼻窦结局测试（SNOT-22）。关于哮喘，评估了哮喘加重的年发生率、7 项哮喘控制问卷（ACQ-7）和肺功能。分析了治疗反应。
经 48 周度普利尤单抗治疗，嗅觉功能、鼻气道阻力、鼻息肉评分、Lund-Mackay 计算机断层扫描评分和 SNOT-22 评分均显著改善。合并哮喘方面，哮喘加重的年发生率降低，ACQ-7 评分和肺功能显著改善。根据 2020 年欧洲鼻窦炎和鼻息肉意见书/欧洲过敏与气道疾病研究与教育论坛标准，15 例（94%）患者在治疗 48 周时为中重度应答者。SNOT-22 评分、ACQ-7 评分、上一年哮喘加重率和血嗜酸性粒细胞计数较高的患者从治疗中获益更多。
度普利尤单抗改善了上、下呼吸道结局，特别是在合并、控制不佳的哮喘的严重 CRSwNP 患者中。
UMIN 临床试验注册：UMIN000038669。
