Viskens A-S, Bollens L, Borgers E, Halewyck S, Hox V, Jorissen M, Lemmens W, Rogister F, Speleman K, Van Gerven L, Vanderveken O, Verhaeghe B, Vroegop A, Martens K, Hellings P W
KU Leuven Department of Microbiology, Immunology and Transplantation, Allergy and Clinical Immunology Research Unit, Leuven, Belgium;Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Faculty of Medicine, KU Leuven, Leuven, Belgium.
Rhinology. 2025 Jun 1;63(3):316-324. doi: 10.4193/Rhin24.509.
Double-blinded placebo-controlled trials have revealed the efficacy of mepolizumab and omalizumab in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). However, real-world efficacy (RWE) data, data on therapeutic response and level of disease control for both biologicals are lacking.
167 patients with uncontrolled severe CRSwNP, meeting national reimbursement criteria, were included with follow-up over 24 weeks. Primary outcomes included changes in nasal congestion (NCS), nasal polyp score (NPS), VAS-scores, SNOT-22, ACQ-5, and AQLQ scores. Secondary outcomes were therapeutic response and disease control according to EUFOREA/EPOS criteria.
Of the 167 CRSwNP patients, 144 received mepolizumab and 23 omalizumab. After 24 weeks, Patient reported outcomes and NPS significantly improved for both biologicals, with significant effects seen at 12 weeks, with further reduction in NPS by 24 weeks in mepolizumab patients. 74% of patients on omalizumab and 81% of patients on mepolizumab continued their therapy beyond 24 weeks, with 47% and 45% of patients on omalizumab and mepolizumab respectively showing an excellent therapeutic response, with only one out of seven having no/poor response. Disease control was reached in one third of the patients at 24 weeks.
Both mepolizumab and omalizumab significantly improved patient-reported outcomes after 24-weeks, with major effects already observed at 12 weeks. Follow-up beyond 24-weeks might reveal additional effects on both control and remission.
双盲安慰剂对照试验已揭示美泊利单抗和奥马珠单抗在治疗伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）中的疗效。然而，缺乏这两种生物制剂的真实世界疗效（RWE）数据、治疗反应数据和疾病控制水平数据。
纳入167例符合国家报销标准的未得到控制的重度CRSwNP患者，进行24周的随访。主要结局包括鼻充血（NCS）、鼻息肉评分（NPS）、视觉模拟评分（VAS）、鼻窦鼻息肉结局测试22项问卷（SNOT-22）、哮喘控制问卷5项（ACQ-5）和哮喘生活质量问卷（AQLQ）评分的变化。次要结局是根据欧洲鼻科学会（EUFOREA）/欧洲鼻窦炎和鼻息肉立场文件（EPOS）标准的治疗反应和疾病控制情况。
167例CRSwNP患者中，144例接受美泊利单抗治疗，23例接受奥马珠单抗治疗。24周后，两种生物制剂的患者报告结局和NPS均显著改善，在12周时即有显著效果，美泊利单抗治疗的患者到24周时NPS进一步降低。74%接受奥马珠单抗治疗的患者和81%接受美泊利单抗治疗的患者在24周后继续治疗，接受奥马珠单抗和美泊利单抗治疗的患者分别有47%和45%显示出极佳的治疗反应，7例中只有1例无反应/反应不佳。24周时三分之一的患者达到疾病控制。
美泊利单抗和奥马珠单抗在24周后均显著改善了患者报告结局，在12周时即已观察到主要效果。24周后的随访可能会揭示对控制和缓解的额外效果。
