De Corso Eugenio, Settimi Stefano, Montuori Claudio, Corbò Marco, Passali Giulio Cesare, Porru Davide Paolo, Lo Verde Simone, Spanu Camilla, Penazzi Daniele, Di Bella Giuseppe Alberto, Nucera Eleonora, Bonini Matteo, Paludetti Gaetano, Galli Jacopo
Unit of Otorhinolaryngology-Head and Neck Surgery, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy.
Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy.
J Clin Med. 2022 May 10;11(10):2684. doi: 10.3390/jcm11102684.
The aim of this study was to evaluate the efficacy of dupilumab in the treatment of severe uncontrolled Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), with or without asthma as add-on therapy with intra-nasal corticosteroids in a real-life setting over the first year of treatment. Our data demonstrated that subcutaneous 300 mg dupilumab administered at home via a pre-filled auto-injector every two weeks, based on indications set by the Italian Medicines Agency, was rapidly effective in reducing the size of polyps, decreasing symptoms of disease, improving quality of life, and recovering olfaction. Significant improvement was observed after only 15 days of treatment, and it progressively increased at 6 and 12 months. Dupilumab was also effective in reducing the local nasal eosinophilic infiltrate, in decreasing the need for surgery and/or oral corticosteroids, and in improving control of associated comorbidities such as chronic eosinophilic otitis media and bronchial asthma. After 12 months of treatment, 96.5% of patients had a moderate/excellent response. From our data, it was evident that there was a group of patients that showed a very early response within one month of therapy, another group with early response within six months from baseline, and a last group that improved later within 12 months. The results of this study support the use of dupilumab as an effective option in the current standard of care for patients affected by severe uncontrolled CRSwNP.
本研究的目的是评估度普利尤单抗在治疗严重难治性慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）中的疗效，无论患者有无哮喘，在真实临床环境中作为鼻内糖皮质激素的附加治疗，观察治疗第一年的情况。我们的数据表明，根据意大利药品管理局设定的适应症，每两周通过预填充自动注射器在家自行皮下注射300mg度普利尤单抗，能迅速有效缩小息肉大小、减轻疾病症状、改善生活质量并恢复嗅觉。治疗仅15天后就观察到显著改善，在6个月和12个月时改善程度逐渐增加。度普利尤单抗还能有效减少局部鼻嗜酸性粒细胞浸润，减少手术和/或口服糖皮质激素的需求，并改善对相关合并症（如慢性嗜酸性粒细胞性中耳炎和支气管哮喘）的控制。治疗12个月后，96.5%的患者有中度/良好反应。从我们的数据来看，很明显有一组患者在治疗1个月内就显示出非常早期的反应，另一组在基线后6个月内有早期反应，最后一组在12个月内较晚才改善。本研究结果支持将度普利尤单抗作为治疗严重难治性CRSwNP患者当前标准治疗方案中的一种有效选择。
