机构：[1]Department of Otorhinolaryngology, Head & Neck Surgery, University of Fukui, Japan[2]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, China临床科室耳鼻咽喉-头颈外科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[3]Department of Otorhinolaryngology, Toho University Ohashi Medical Centre, Japan[4]Department of Otolaryngology, Kansai Medical University, Japan[5]Department of Otorhinolaryngology, Head and Neck Surgery, Showa University, Japan[6]ENT Department, University of Münster, Germany[7]Department of Otolaryngology - Head and Neck Surgery, Eastern Virginia Medical School, USA[8]Clinical Statistics, GSK, GSK House, Brentford, UK[9]Veramed Ltd, Twickenham, UK[10]Global Medical Affairs, Specialty Care, GSK, Durham, NC, USA*[11]Clinical Development, Respiratory, GSK, Shanghai, China[12]Clinical Development (Respiratory), Respiratory Medical Affairs & Development, GSK Japan, Tokyo, Japan[13]Clinical Sciences, Respiratory, GSK, Brentford, Middlesex, UK
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.
基金：
This study was funded by GSK (GSK ID:209692; NCT04607005).
第一作者机构：[1]Department of Otorhinolaryngology, Head & Neck Surgery, University of Fukui, Japan
共同第一作者：
通讯作者：
通讯机构：[2]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, China[*1]Department of Otolaryngology Head and Neck Surgery and Department of Allergy Beijing TongRen Hospital Capital Medical University No.1, Dongjiaominxiang Dong Cheng District Beijing 100730 P.R. China 100051
推荐引用方式(GB/T 7714)：
Fujieda S,Wang Chengshuo,Yoshikawa M,et al.Mepolizumab in CRSwNP/ECRS and NP: the phase III randomised MERIT trial in Japan, China, and Russia[J].Rhinology.2024,62(5):doi:10.4193/Rhin24.156.
APA：
Fujieda S,Wang Chengshuo,Yoshikawa M,Asako M,Suzaki I...&Zhang Luo.(2024).Mepolizumab in CRSwNP/ECRS and NP: the phase III randomised MERIT trial in Japan, China, and Russia.Rhinology,62,(5)
MLA：
Fujieda S,et al."Mepolizumab in CRSwNP/ECRS and NP: the phase III randomised MERIT trial in Japan, China, and Russia".Rhinology 62..5(2024)
