替泽利尤单抗在日本慢性鼻窦炎伴鼻息肉患者中的疗效与安全性：随机WAYPOINT研究的亚人群分析
Efficacy and safety of tezepelumab in Japanese patients with chronic rhinosinusitis with nasal polyps: A subpopulation analysis of the randomized WAYPOINT study.
文献信息
| PMID | 42868896 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Nobuyoshi Otori |
| 作者单位 | Department of Otorhinolaryngology, Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan. |
| 期刊 | Auris, nasus, larynx |
| SCI 分区 | Q2 |
| IF | 1.7 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
目的： 替泽利尤单抗是一种抗胸腺基质淋巴细胞生成素单克隆抗体，可有效缩小慢性鼻窦炎伴鼻息肉（CRSwNP）患者的息肉体积。在涵盖10个国家（包括日本）的3期WAYPOINT研究中，替泽利尤单抗还减少了鼻息肉手术和全身性糖皮质激素（SCS）的需求。本描述性亚组分析评估了入组WAYPOINT研究的日本患者中替泽利尤单抗的疗效与安全性；未进行正式的统计学假设检验。
方法： 患有重度未控制CRSwNP的成人被随机分配接受皮下注射替泽利尤单抗210 mg或安慰剂，每4周一次。评估包括共同主要终点（从基线至第52周总鼻息肉评分[NPS]和双周平均鼻塞评分[NCS]的变化）、关键次要终点（嗅觉丧失评分、22项鼻窦结局测试[SNOT-22]总分、Lund-Mackay鼻窦评分，以及鼻息肉手术、SCS或两者兼有的需求）以及日本人群的安全性结局。
结果： 在总共408例患者中，33例在日本入组（替泽利尤单抗，n=17；安慰剂，n=16）。在日本人群中，替泽利尤单抗在第52周时相对于安慰剂在总NPS（最小二乘均值较基线变化[95%置信区间] -2.30 [-3.17, -1.44] vs -1.24 [-2.13, -0.35]）和双周平均NCS（-1.63 [-2.01, -1.25] vs -1.08 [-1.47, -0.69]）方面显示出数值上有利的降低。与安慰剂相比，替泽利尤单抗在嗅觉丧失、SNOT-22和Lund-Mackay评分方面也显示出较基线的数值上有利的降低。接受替泽利尤单抗的日本患者中没有一例需要鼻息肉手术或SCS。安全性与总体研究人群一致。
结论： 在这项探索性亚人群分析中，替泽利尤单抗在重度未控制CRSwNP的日本患者中，在多个终点上相对于安慰剂显示出数值上有利的结果，且耐受性良好，研究结果与总体WAYPOINT人群基本一致。
临床试验注册： NCT04851964（可访问：https://clinicaltrials.gov/study/NCT04851964）。
英文摘要
OBJECTIVE: Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, effectively reduced polyp size in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Tezepelumab also reduced the need for nasal polyp surgery and systemic corticosteroids (SCS) in the phase 3 WAYPOINT study across 10 countries (including Japan). This descriptive subgroup analysis evaluated the efficacy and safety of tezepelumab in Japanese patients enrolled in the WAYPOINT study; no formal statistical hypothesis testing was performed.
METHODS: Adults with severe uncontrolled CRSwNP were randomized to receive subcutaneous tezepelumab 210 mg or placebo once every 4 weeks. Evaluations included coprimary endpoints (change from baseline to week 52 in total Nasal Polyp Score [NPS] and bi-weekly mean Nasal Congestion Score [NCS]), key secondary endpoints (loss of smell score, total score on the SinoNasal Outcome Test 22-item [SNOT-22], and Lund-Mackay sinus score, and the need for nasal polyp surgery, SCS, or both), and safety outcomes in the Japanese population.
RESULTS: Of the 408 patients overall, 33 were enrolled in Japan (tezepelumab, n = 17; placebo, n = 16). In the Japanese population, tezepelumab showed numerically favorable reductions versus placebo at week 52 in total NPS (least squares mean change from baseline [95% confidence interval] -2.30 [-3.17, -1.44] vs -1.24 [-2.13, -0.35]) and bi-weekly mean NCS (-1.63 [-2.01, -1.25] vs -1.08 [-1.47, -0.69]). Loss of smell, SNOT-22, and Lund-Mackay scores also showed numerically favorable reductions from baseline with tezepelumab compared with placebo. No Japanese patients receiving tezepelumab required nasal polyp surgery or SCS. Safety was consistent with the overall study population.
CONCLUSION: In this exploratory subpopulation analysis, tezepelumab showed numerically favorable results compared with placebo across multiple endpoints and was well tolerated in Japanese patients with severe uncontrolled CRSwNP, with findings generally consistent with the overall WAYPOINT population.
CLINICAL TRIAL REGISTRATION: NCT04851964 (Available at: https://clinicaltrials.gov/study/NCT04851964).