Albert Szent-Gyorgyi Health Center, University of Szeged, Department of Otorhinolaryngology, Head.
Semmelweis University, Department of Otorhinolaryngology, Head and Neck Surgery, Budapest, Hungary.
Rhinology. 2024 Aug 1;62(4):410-420. doi: 10.4193/Rhin23.278.
Research on the immune mechanism behind chronic rhinosinusitis (CRS) has revealed various new endotypes, leading to targeted therapies, especially for severe uncontrolled CRS. Biologics are novel therapeutic strategies providing targeted treatment for the difficult-to-treat recalcitrant CRSwNP patients. Dupilumab is a fully human-derived monoclonal antibody that binds to IL4Rα, inhibiting the signalling of both IL-4 and IL-13. In Hungary, it is approved for the treatment of uncontrolled CRSwNP according to criteria based on the EPOS2020 and the Hungarian guidelines.
This study aimed to collect and evaluate real-world therapeutic data of CRSwNP patients treated with dupilumab. One hundred thirty-five patients from eight different referral centres have been enrolled in this study, who received dupilumab since 2020. All subjects were adult patients (over 18 years) with uncontrolled CRSwNP. Baseline data collection included demographics, medical history, previous surgeries, related comorbidities, total endoscopic nasal polyp score (NPS), SNOT22, nasal congestion parameters measured with visual analogue scale (VAS) and nasal obstruction evaluation scale (NOSE), loss of smell score (LSS) and eosinophil count. 300 mg dupilumab was administered subcutaneously every second week. Follow up visits were performed after 6 and 12 months.
After 6 and 12 months of treatment significant improvement was detected in all clinical parameters. Safety was proved, no severe side effects occurred, and no rescue treatment was necessary.
Our real-life findings show that continuous dupilumab treatment is effective and safe in daily clinical practice in CRSwNP and other type 2 comorbidities such as bronchial asthma and NERD.
慢性鼻-鼻窦炎（CRS）免疫机制的研究揭示了各种新的内表型，从而产生了靶向治疗方法，尤其是针对严重的、无法控制的 CRS。生物制剂是一种新型治疗策略，为难以治疗的顽固 CRSwNP 患者提供了靶向治疗。度普利尤单抗是一种完全人源衍生的单克隆抗体，可与 IL4Rα结合，抑制 IL-4 和 IL-13 的信号传导。在匈牙利，根据基于 EPOS2020 和匈牙利指南的标准，该药被批准用于治疗无法控制的 CRSwNP。
本研究旨在收集和评估接受度普利尤单抗治疗的 CRSwNP 患者的真实世界治疗数据。本研究共纳入了 8 家不同转诊中心的 135 名患者，他们自 2020 年起开始接受度普利尤单抗治疗。所有患者均为患有无法控制的 CRSwNP 的成年患者（18 岁以上）。基线数据收集包括人口统计学、病史、既往手术、相关合并症、总内镜鼻息肉评分（NPS）、SNOT22、使用视觉模拟量表（VAS）和鼻阻塞评估量表（NOSE）测量的鼻塞参数、嗅觉丧失评分（LSS）和嗜酸性粒细胞计数。每两周皮下注射 300mg 度普利尤单抗。在 6 个月和 12 个月时进行随访。
治疗 6 个月和 12 个月后，所有临床参数均显著改善。安全性得到证实，未发生严重副作用，也无需进行抢救治疗。
我们的真实研究结果表明，在 CRSwNP 及支气管哮喘和 NERD 等 2 型合并症的日常临床实践中，持续接受度普利尤单抗治疗是有效且安全的。
