Department of Otorhinolaryngology, Head and Neck Surgery, University of Fukui, Japan.
Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, China.
Rhinology. 2024 Oct 1;62(5):576-589. doi: 10.4193/Rhin24.156.
This randomised, double-blind, placebo-controlled, parallel-group, 52-week Phase III study (MERIT; NCT04607005) assessed mepolizumab efficacy and safety in patients with chronic rhinosinusitis with nasal polyps (CRSwNP)/eosinophilic CRS (ECRS) in Japan, Russia, and China, for which data are limited.
Eligible patients (enrolled at 60 centres) had blood eosinophil count >2%, endoscopic bilateral NP score ≥5, nasal obstruction visual analogue scale (VAS) score >5, ≥2 sinonasal symptoms, and either previous sinus surgery or systemic corticosteroid use/intolerance. Patients were randomised (1:1) to receive mepolizumab 100 mg subcutaneously or placebo every 4 weeks, plus standard of care. Co-primary endpoints: change from baseline in total endoscopic NP score (ENPS) (Week 52) and nasal obstruction VAS score (Weeks 49-52). Post hoc analyses conducted in a modified intent-to-treat (mITT) population excluded patients from two study sites, related to Good Clinical Practice violations by the Site Management Organisation overseeing these sites. These were considered the primary efficacy analyses.
In the mITT population, mepolizumab (n=80) versus placebo (n=83) significantly improved nasal obstruction VAS score from baseline to Week 49-52 and was associated with a trend of total ENPS improvements at Week 52. Mepolizumab/placebo on-treatment adverse events (AEs) occurred in 68/84 and 65/85 patients in the safety population (treatment-related AEs: 2/84 and 5/85, respectively), and on-treatment serious AEs in 0/84 and 4/85 patients, respectively (no fatalities reported).
Mepolizumab was effective and well-tolerated in patients with CRSwNP/ECRS from Japan, Russia, and China.
这项随机、双盲、安慰剂对照、平行分组、52 周 III 期研究（MERIT；NCT04607005）评估了美泊利珠单抗在日本、俄罗斯和中国患有慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）/嗜酸性 CRS（ECRS）的患者中的疗效和安全性，这些地区的数据有限。
符合条件的患者（在 60 个中心登记）的血液嗜酸性粒细胞计数>2%，双侧鼻息肉内镜评分≥5，鼻腔阻塞视觉模拟量表（VAS）评分>5，≥2 个鼻-鼻窦症状，且既往鼻窦手术或全身皮质类固醇使用/不耐受。患者按 1:1 随机分配接受美泊利珠单抗 100mg 皮下注射或安慰剂，每 4 周一次，同时接受标准治疗。主要共同终点：从基线到第 52 周的总内镜鼻息肉评分（ENPS）（第 52 周）和鼻腔阻塞 VAS 评分（第 49-52 周）的变化。在一个修改后的意向治疗（mITT）人群中进行的事后分析排除了来自两个研究地点的患者，这两个地点与监督这些地点的现场管理组织违反良好临床实践有关。这些被认为是主要疗效分析。
在 mITT 人群中，与安慰剂相比，美泊利珠单抗（n=80）在第 49-52 周时显著改善了鼻腔阻塞 VAS 评分，且在第 52 周时总 ENPS 有改善的趋势。在安全性人群中，美泊利珠单抗/安慰剂治疗期间出现不良事件（AE）的患者分别为 68/84 和 65/85 例（治疗相关 AE：分别为 2/84 和 5/85 例），治疗期间发生严重不良事件的患者分别为 0/84 和 4/85 例（无死亡报告）。
美泊利珠单抗在日本、俄罗斯和中国的 CRSwNP/ECRS 患者中是有效且耐受良好的。
