ABSTRACT

Introduction: Chronic rhinosinusitis with nasal polyposis (CRSwNP) poses a significant healthcare challenge, with diminished quality of life for patients and high costs and resource utilization for disease management. The understanding of CRSwNP pathophysiology has progressed with identification of various inflammatory biomarkers and subsequent development of monoclonal antibodies that target the underlying mechanisms of inflammation.

Areas covered: Omalizumab is a biologic agent for CRSwNP treatment that targets immunoglobulin (Ig)-E. The US FDA has approved the use of omalizumab as an add-on biologic therapy for nasal polyposis in December 2020. Two Phase III clinical trials, POLYP 1 and POLYP 2, have shown that omalizumab improves both subjective patient-reported outcomes and objective physician-evaluated metrics for CRSwNP. Ongoing studies are still exploring the efficacy, safety, and cost-effectiveness of biologics for CRSwNP.

Expert opinion: Biologics will continue develop as a viable management option for CRSwNP. Omalizumab is regarded as a promising addition to current treatment strategies for refractory disease.

摘要

简介：慢性鼻窦炎伴鼻息肉病 (CRSwNP) 对医疗保健提出了重大挑战，患者的生活质量下降，疾病管理的成本和资源利用率很高。随着对各种炎症生物标志物的鉴定以及随后针对炎症潜在机制的单克隆抗体的开发，对 CRSwNP 病理生理学的理解取得了进展。

涵盖的领域：奥马珠单抗是一种针对免疫球蛋白 (Ig)-E 的 CRSwNP 治疗的生物制剂。美国 FDA 已于 2020 年 12 月批准使用奥马珠单抗作为鼻息肉病的附加生物疗法。POLYP 1 和 POLYP 2 两项 III 期临床试验表明，奥马珠单抗改善了主观患者报告的结果和客观的医生-评估 CRSwNP 的指标。正在进行的研究仍在探索生物制剂对 CRSwNP 的疗效、安全性和成本效益。

专家意见：生物制剂将继续发展为 CRSwNP 的可行管理选择。奥马珠单抗被认为是对当前难治性疾病治疗策略的有希望的补充。