在第三阶段SYNAPSE研究中,美泊利单抗减少慢性鼻窦炎伴NP的鼻息肉(NP)大小和鼻塞。
我们试图评估美泊利单抗在SYNAPSE患者中的疗效,阿司匹林加重呼吸道疾病(AERD),和基线血液嗜酸性粒细胞计数(BEC)。
SYNAPSE,一个随机的,双盲,52周研究(NCT03085797),纳入重度双侧慢性鼻-鼻窦炎伴NP患者,尽管经鼻内皮质类固醇治疗,仍可接受手术治疗.患者接受4周皮下注射美泊利单抗100mg或安慰剂加标准治疗52周。共同主要终点是内窥镜NP总评分(52周)和鼻塞视觉模拟量表评分(49-52周)的变化。按哮喘共病和AERD状态进行亚组分析,和事后由BEC,是探索性的。
分析包括407例患者(289例哮喘;108例AERD;371例和278例BEC计数≥150或≥300个细胞/μL,分别)。在合并症疾病(哮喘:52.9%vs29.5%;AERD:51.1%vs20.6%)和基线BEC亚组(<150细胞/μL:55.0%vs31.3%;≥150细胞/μL:49.5%vs28.1%;<300%细胞/μL:50.4%vs58.1%;<300%细胞/μL:50.4%:在没有合并哮喘或AERD的患者中观察到类似的趋势。在合并症亚组中,使用美泊利单抗与安慰剂相比,更多患者的鼻塞VAS评分改善超过3分。
Mepolizumab可减少慢性鼻窦炎伴NP患者的息肉大小和鼻塞,无论是否存在哮喘或AERD合并症。
In the phase III SYNAPSE study, mepolizumab reduced nasal polyp (NP) size and nasal obstruction in chronic rhinosinusitis with NP.
We sought to assess the efficacy of mepolizumab in patients from SYNAPSE grouped by comorbid asthma, aspirin-exacerbated respiratory disease (AERD), and baseline blood eosinophil count (BEC).
SYNAPSE, a randomized, double-blind, 52-week study (NCT03085797), included patients with severe bilateral chronic rhinosinusitis with NP eligible for surgery despite intranasal corticosteroid treatment. Patients received 4-weekly subcutaneous mepolizumab 100 mg or placebo plus standard of care for 52 weeks. Coprimary end points were change in total endoscopic NP score (week 52) and nasal obstruction visual analog scale score (weeks 49-52). Subgroup analyses by comorbid asthma and AERD status, and post hoc by BEC, were exploratory.
Analyses included 407 patients (289 with asthma; 108 with AERD; 371 and 278 with BEC counts ≥150 or ≥300 cells/μL, respectively). The proportion of patients with greater than or equal to 1-point improvement from baseline in NP score was higher with mepolizumab versus placebo across comorbid diseases (asthma: 52.9% vs 29.5%; AERD: 51.1% vs 20.6%) and baseline BEC subgroups (<150 cells/μL: 55.0% vs 31.3%; ≥150 cells/μL: 49.5% vs 28.1%; <300 cells/μL: 50.7% vs 29.0%; ≥300 cells/μL: 50.4% vs 28.1%). A similar trend was observed in patients without comorbid asthma or AERD. More patients had more than 3-point improvement in nasal obstruction VAS score with mepolizumab versus placebo across comorbid subgroups.
Mepolizumab reduced polyp size and nasal obstruction in chronic rhinosinusitis with NP regardless of the presence of comorbid asthma or AERD.