Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.
Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland, Oregon, USA.
Int Forum Allergy Rhinol. 2023 Feb;13(2):116-128. doi: 10.1002/alr.23059. Epub 2022 Sep 4.
Comparative effectiveness research between endoscopic sinus surgery (ESS) and biologic therapy for severe chronic rhinosinusitis with nasal polyposis (CRSwNP) is a nascent field as new therapeutic modalities become clinically available.
A prospective, multicenter cohort of CRSwNP patients, undergoing ESS between 2011 and 2019, were compared to phase-3 biologic trial data. Patients undergoing ESS received baseline nasal endoscopy quantified via Lund-Kennedy (LK) grading. Patients meeting inclusion criteria, modified from Dupilumab-LIBERTY-NP-24&52, omalizumab-POLYP-1&2, and Mepolizumab-SYNAPSE clinical trials, were included in this study. Baseline characteristics and outcome measures were compared between these cohorts at 24 weeks and 52 weeks, when possible.
A total of 111 CRSwNP patients met modified inclusion criteria. There were no statistically significant differences in baseline age, sex, asthma status, aspirin-exacerbated respiratory disease status, smell identification, LK-polyp score, and Lund-Mackay computed tomography (CT) scores between ESS and biologic groups. At 24 weeks, ESS demonstrated significantly greater improvements in 22-item Sino-Nasal Outcome Test (SNOT-22) compared to one (of two) dupilumab trials (p < 0.05) and both omalizumab trials (p < 0.001). ESS associated with significantly lower nasal polyp scores (NPS) compared to dupilumab (p < 0.001) and omalizumab (p < 0.001), despite comparable improvements in smell identification (p > 0.05). At 52 weeks, ESS resulted in statistically similar improvement in SNOT-22 scores compared to dupilumab (p = 0.21), but NPS remained significantly lower in the ESS group compared to dupilumab (p < 0.001) and mepolizumab (p < 0.001).
At 24 weeks and 52 weeks, ESS offers comparable SNOT-22 improvements compared to dupilumab. ESS and dupilumab offer comparable improvement in smell identification at 24 weeks. Compared to omalizumab, ESS offers superior SNOT-22 improvements. ESS offers significantly greater reductions in polyp size compared to omalizumab, dupilumab, and mepolizumab therapies.
内镜鼻窦手术（ESS）与生物疗法治疗严重慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）的比较效果研究是一个新兴领域，因为新的治疗方法已经在临床上应用。
对 2011 年至 2019 年间接受 ESS 的 CRSwNP 患者进行前瞻性、多中心队列研究，并与 3 期生物试验数据进行比较。接受 ESS 的患者接受了基于 Lund-Kennedy（LK）评分的基线鼻内镜检查。符合从 Dupilumab-LIBERTY-NP-24&52、omalizumab-POLYP-1&2 和 Mepolizumab-SYNAPSE 临床试验中修改的纳入标准的患者被纳入本研究。在 24 周和 52 周时，比较了这两组患者的基线特征和结局指标。
共有 111 例 CRSwNP 患者符合修改后的纳入标准。ESS 组和生物治疗组在基线年龄、性别、哮喘状态、阿司匹林加重的呼吸道疾病状态、嗅觉识别、LK-息肉评分和 Lund-Mackay 计算机断层扫描（CT）评分方面无统计学差异。在 24 周时，ESS 与两项 Dupilumab 试验之一（p<0.05）和两项 omalizumab 试验（p<0.001）相比，22 项鼻-鼻窦结局测试（SNOT-22）的改善明显更大。与 Dupilumab（p<0.001）和 omalizumab（p<0.001）相比，ESS 与明显较低的鼻息肉评分（NPS）相关，尽管嗅觉识别有相似的改善（p>0.05）。在 52 周时，与 Dupilumab 相比，ESS 导致 SNOT-22 评分的统计学上相似的改善（p=0.21），但与 Dupilumab 和 Mepolizumab 相比，ESS 组的 NPS 仍明显较低（p<0.001）。
在 24 周和 52 周时，ESS 与 Dupilumab 相比，SNOT-22 的改善相似。在 24 周时，ESS 与 Dupilumab 相比，嗅觉识别有相似的改善。与 omalizumab 相比，ESS 可显著改善 SNOT-22。与 omalizumab、Dupilumab 和 Mepolizumab 治疗相比，ESS 可显著减少息肉大小。
