Lipworth Brian J, Chan Rory
Tayside Rhinology Mega-Clinic & Scottish Centre for Respiratory Research, Ninewells Hospital, University of Dundee, Dundee, United Kingdom.
Tayside Rhinology Mega-Clinic & Scottish Centre for Respiratory Research, Ninewells Hospital, University of Dundee, Dundee, United Kingdom.
J Allergy Clin Immunol Pract. 2021 Dec;9(12):4235-4238. doi: 10.1016/j.jaip.2021.07.023. Epub 2021 Jul 28.
Patients with severe chronic rhinosinusitis with nasal polyps represent an unmet clinical need in terms of recurrent disease despite current medical and surgical therapy. Targeting type 2 inflammatory cytokines (IL4/5/13) appears to be a promising therapeutic approach for such patients akin to what has already been seen in severe asthma. An indirect comparison from phase 3 placebo-controlled trials has shown relative improvements in the coprimary end point of nasal polyp score (NPS) ranging from a 15% reduction (-0.8 units) with mepolizumab, 18% with omalizumab (-1.14 units), and 35% (-2.06 units) with dupilumab. This trend was mirrored by relative improvements in health status with the 22-item Sinonasal Outcome Test score showing a 21% reduction (-13.7 units) with mepolizumab, 27% (-16.1 units) with omalizumab, and 43% (-21.1 units) with dupilumab, all exceeding the minimal clinically important difference of 8.9 units. All biologics improved the coprimary end point of nasal airway blockage and also reduced the need for rescue medical and/or surgical polypectomy. We advocate performing real-life studies looking at the response to biologics in patients who are at increased risk for disease recurrence, including initial optimal medical and surgical polyp clearance before commencing biologics.
尽管目前有药物和手术治疗,但重度慢性鼻窦炎伴鼻息肉患者的疾病复发问题仍未得到满足的临床需求。靶向2型炎症细胞因子(IL4/5/13)似乎是治疗这类患者的一种有前景的治疗方法,类似于在重度哮喘中已经看到的情况。来自3期安慰剂对照试验的间接比较显示,鼻息肉评分(NPS)的共同主要终点有相对改善,美泊利单抗使鼻息肉评分降低15%(-0.8分),奥马珠单抗降低18%(-1.14分),度普利尤单抗降低35%(-2.06分)。健康状况的相对改善也反映了这一趋势,22项鼻鼻窦结局测试评分显示,美泊利单抗使评分降低21%(-13.7分),奥马珠单抗降低27%(-16.1分),度普利尤单抗降低43%(-21.1分),均超过了8.9分的最小临床重要差异。所有生物制剂都改善了鼻气道阻塞的共同主要终点,也减少了急救药物和/或手术息肉切除的需求。我们主张开展实际研究,观察疾病复发风险增加的患者对生物制剂的反应,包括在开始使用生物制剂之前进行初始最佳药物和手术息肉清除。