Seys Sven F, Schneider Sven, de Kinderen Joost, Reitsma Sietze, Cavaliere Carlo, Tomazic Peter-Valentin, Morgenstern Christina, Mortuaire Geoffrey, Wagenmann Martin, Bettio Giulia, Ciofalo Andrea, Diamant Zuzana, Eckl-Dorna Julia, Fokkens Wytske J, Holzmeister Clemens, Mariën Gert, Masieri Simonetta, Otten Josje, Scheckenbach Kathrin, Tu Aldine, Bachert Claus
Galenus Health, Hasselt, Belgium.
Department of Otorhinolaryngology, Head and Neck Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.
J Allergy Clin Immunol. 2025 Feb;155(2):451-460. doi: 10.1016/j.jaci.2024.10.016. Epub 2024 Oct 31.
Pivotal studies with dupilumab demonstrated clinically relevant improvements in nasal polyp score, symptom score, and quality-of-life score in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
We evaluated the effectiveness of dupilumab in a large-scale CRSwNP cohort from 6 European tertiary-care centers.
Nasal polyp score, Sinonasal Outcome Test 22 score, visual analog scale for total sinus symptoms, loss of smell, and nasal blockage, and Asthma Control Test (ACT) score were collected from hospital records and assessed at baseline and again at 24 and 52 weeks' treatment with dupilumab in CRSwNP patients. Treatment effectiveness was evaluated in relation to demographic and lifestyle factors, sinus surgery history, presence of comorbidities, and blood eosinophil counts (BEC). Treatment response was evaluated according to European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) 2021 criteria.
All patient outcomes improved at 24 and 52 weeks' treatment compared to baseline. Dupilumab showed effectiveness independent of age, sex, body mass index, smoking status, prior sinus surgery, presence of asthma, nonsteroidal anti-inflammatory drug-exacerbated respiratory disease, allergy, or baseline BEC. A total of 92.5% and 94.4% showed an improvement in at least 1 EUFOREA criterion at 24 and 52 weeks, respectively; 54.4% and 68.2% met all 4 of the more stringent EUFOREA criteria at 24 and 52 weeks, respectively.
Real-world evaluation of dupilumab effectiveness demonstrates a robust and sustained response in at least two thirds of patients at 52 weeks' treatment. Favorable treatment response was independent of the number of sinus surgery procedures, major comorbidities, or baseline systemic levels of type 2 inflammation.
度普利尤单抗的关键研究表明,在伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)患者中,鼻息肉评分、症状评分和生活质量评分有临床意义的改善。
我们评估了度普利尤单抗在来自6个欧洲三级医疗中心的大规模CRSwNP队列中的有效性。
从医院记录中收集鼻息肉评分、鼻窦结局测试22评分、总鼻窦症状视觉模拟量表、嗅觉丧失和鼻塞情况,以及哮喘控制测试(ACT)评分,并在基线时以及CRSwNP患者接受度普利尤单抗治疗24周和52周后再次进行评估。根据人口统计学和生活方式因素、鼻窦手术史、合并症的存在情况以及血液嗜酸性粒细胞计数(BEC)评估治疗效果。根据欧洲过敏和气道疾病研究与教育论坛(EUFOREA)2021标准评估治疗反应。
与基线相比,所有患者的结局在治疗24周和52周时均有所改善。度普利尤单抗显示出的有效性与年龄、性别、体重指数、吸烟状况、既往鼻窦手术、哮喘的存在、非甾体抗炎药诱发的呼吸道疾病、过敏或基线BEC无关。分别有92.5%和94.4%的患者在24周和52周时至少有1项EUFOREA标准得到改善;分别有54.4%和68.2%的患者在24周和52周时符合所有4项更严格的EUFOREA标准。
度普利尤单抗有效性的真实世界评估表明,在治疗52周时,至少三分之二的患者有强劲且持续的反应。良好的治疗反应与鼻窦手术次数、主要合并症或2型炎症的基线全身水平无关。