Allergy Center, Department of Otolaryngology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.
Allergy Center, Department of Otolaryngology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China,
ORL J Otorhinolaryngol Relat Spec. 2023;85(3):128-140. doi: 10.1159/000529918. Epub 2023 Apr 5.
Chronic rhinosinusitis (CRS) is a common inflammatory disease in otolaryngology, mainly manifested as nasal congestion, nasal discharge, facial pain/pressure, and smell disorder. CRS with nasal polyps (CRSwNP), an important phenotype of CRS, has a high recurrence rate even after receiving corticosteroids and/or functional endoscopic sinus surgery. In recent years, clinicians have focused on the application of biological agents in CRSwNP. However, it has not reached a consensus on the timing and selection of biologics for the treatment of CRS so far.
We reviewed the previous studies of biologics in CRS and summarized the indications, contraindications, efficacy assessment, prognosis, and adverse effects of biologics. Also, we evaluated the treatment response and adverse reactions of dupilumab, omalizumab, and mepolizumab in the management of CRS and made recommendations.
Dupilumab, omalizumab, and mepolizumab have been approved for the treatment of CRSwNP by the US Food and Drug Administration. Type 2 and eosinophilic inflammation, need for systemic steroids or contraindication to systemic steroids, significantly impaired quality of life, anosmia, and comorbid asthma are required for the use of biologics. Based on current evidence, dupilumab has the prominent advantage in improving quality of life and reducing the risk of comorbid asthma in CRSwNP among the approved monoclonal antibodies. Most patients tolerate biological agents well in general with few major or severe adverse effects. Biologics have provided more options for severe uncontrolled CRSwNP patients or patients who refuse to have surgery. In the future, more novel biologics will be assessed in high-quality clinical trials and applied clinically.
慢性鼻-鼻窦炎（CRS）是耳鼻喉科的一种常见炎症性疾病，主要表现为鼻塞、流涕、面部疼痛/压痛和嗅觉障碍。伴有鼻息肉（CRSwNP）的 CRS 是 CRS 的一个重要表型，即使在接受皮质类固醇和/或功能性内镜鼻窦手术治疗后，其复发率仍很高。近年来，临床医生专注于生物制剂在 CRSwNP 中的应用。然而，迄今为止，对于生物制剂治疗 CRS 的时机和选择尚未达成共识。
我们复习了生物制剂治疗 CRS 的既往研究，并总结了生物制剂的适应证、禁忌证、疗效评估、预后和不良反应。此外，我们评估了度普利尤单抗、奥马珠单抗和美泊利珠单抗在 CRS 治疗中的治疗反应和不良反应，并提出了建议。
度普利尤单抗、奥马珠单抗和美泊利珠单抗已获美国食品和药物管理局批准用于治疗 CRSwNP。2 型和嗜酸性粒细胞炎症、需要全身皮质类固醇或全身皮质类固醇禁忌、生活质量显著受损、嗅觉丧失和合并哮喘是使用生物制剂的适应证。基于目前的证据，在已批准的单克隆抗体中，度普利尤单抗在改善 CRSwNP 患者的生活质量和降低合并哮喘风险方面具有突出优势。大多数患者对生物制剂总体耐受良好，仅有少数出现重大或严重不良反应。生物制剂为严重的、无法控制的 CRSwNP 患者或拒绝手术的患者提供了更多的治疗选择。未来，将在高质量临床试验中评估更多新型生物制剂，并将其应用于临床。
