Schmale Isaac L, Poulakis Alexander, Abend Audrey, Luitje Martha E, Man Li-Xing
Department of Otolaryngology Head and Neck Surgery, University of Rochester Medical Center, Rochester, NY; University of Rochester School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY.
University of Rochester School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY.
J Allergy Clin Immunol Pract. 2023 Oct;11(10):3203-3210. doi: 10.1016/j.jaip.2023.07.038. Epub 2023 Aug 4.
Biologic medications are increasingly incorporated into chronic rhinosinusitis with nasal polyps (CRSwNP) management. However, little is known about prescribing patterns in real-world settings and how this relates to proposed international guidelines and outcomes.
To characterize use patterns of dupilumab for CRSwNP better in relation to proposed guidelines and explore real-world outcomes.
We used the TriNetX Web-based tool to identify patients who were prescribed dupilumab for CRSwNP. Patients prescribed dupilumab for a CRSwNP indication were included for analysis. Dupilumab initiation criteria were determined via the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS2020).
In total, 121 patients were identified who were prescribed dupilumab for a CRSwNP indication. Of these, 86 (71%) met EPOS2020 indications for biologic initiation and 35 (29%) did not. Overall, patients had significant improvements in the 22-item SinoNasal Outcome Test scores (mean improvement of 24.3 points) and nasal polyp scores (mean improvement of 1.0 point). However, 20 patients (30%) did not show meaningful improvement in the 22-item SinoNasal Outcome Test scores. Twenty-one patients (17%) failed a previous biologic attempt. Therapy was discontinued by six patients (5%) due to side effects, and by six (5%) owing to a lack of efficacy.
In our experience, patients prescribed dupilumab for CRSwNP frequently may not meet EPOS2020 Guidelines. Over 25% of those who do not meet criteria may not have CRSwNP. Overall, dupilumab use among well-selected patients appears to be safe and effective. Further real-world study of biologic use for CRSwNP will help improve its judicious use and identify populations who benefit most from biologic therapies.
生物制剂越来越多地被纳入慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）的治疗中。然而，对于真实世界中的用药模式以及其与国际指南和治疗效果之间的关系，我们知之甚少。
更好地描述度普利尤单抗在CRSwNP治疗中的使用模式，并探讨其在真实世界中的治疗效果。
我们使用基于网络的TriNetX工具来识别被处方度普利尤单抗用于CRSwNP治疗的患者。纳入被处方度普利尤单抗用于CRSwNP适应症的患者进行分析。度普利尤单抗的起始标准根据《2020年欧洲鼻窦炎和鼻息肉立场文件》（EPOS2020）确定。
总共识别出121例被处方度普利尤单抗用于CRSwNP适应症的患者。其中，86例（71%）符合EPOS2020生物制剂起始治疗的适应症，35例（29%）不符合。总体而言，患者在22项鼻-鼻窦结局测试（SNOT-22）评分（平均改善24.3分）和鼻息肉评分（平均改善1.0分）方面有显著改善。然而，20例患者（30%）在22项鼻-鼻窦结局测试评分中未显示出有意义的改善。21例患者（17%）之前的生物制剂治疗失败。6例患者（5%）因副作用而停药，6例患者（5%）因缺乏疗效而停药。
根据我们的经验，被处方度普利尤单抗用于CRSwNP治疗的患者可能经常不符合EPOS2020指南。超过25%不符合标准的患者可能并非CRSwNP。总体而言，在精心挑选的患者中使用度普利尤单抗似乎是安全有效的。进一步对CRSwNP生物制剂使用的真实世界研究将有助于改善其合理使用，并确定从生物治疗中获益最大的人群。
