Hopkins Claire, Buchheit Kathleen M, Heffler Enrico, Cohen Noam A, Olze Heidi, Khan Asif H, Msihid Jérôme, Siddiqui Shahid, Nash Scott, Jacob-Nara Juby A, Rowe Paul J, Deniz Yamo
Department of Otorhinolaryngology - Head and Neck Surgery, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Division of Allergy and Clinical Immunology, Brigham and Women's Hospital, Boston, MA, USA.
J Asthma Allergy. 2022 Jun 7;15:767-773. doi: 10.2147/JAA.S363527. eCollection 2022.
Patients with asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, increasing disease burden and complicating treatment. These post hoc analyses investigated disease-specific health-related quality of life (HRQoL) and general health status in the randomized, placebo-controlled QUEST study (NCT02414854) in patients treated with dupilumab for moderate-to-severe asthma with comorbid CRS. Patients received 300 mg of dupilumab or placebo every 2 weeks for 52 weeks. CRS HRQoL was assessed by the 22-item Sino-Nasal Outcome Test (SNOT-22; items scored 0-5). The 22 items are categorized into 5 domains (nasal, ear/facial, sleep, function, and emotion), and patients report the top 5 most important items affecting their health. General health status was assessed by Euro-QoL visual analog scale (EQ-VAS). Of 1902 patients, 382 (20.1%) self-reported comorbid CRS; 193 patients receiving dupilumab 300 mg q2w or matched placebo were included in this analysis. At baseline, the most impacted SNOT-22 domain was nasal, and general health status was below population norms. Patients rated "decreased sense of taste/smell," "nasal blockage," "cough," "reduced productivity," and "wake up tired" as the 5 most important SNOT-22 items affecting their health. Percentage change from baseline in SNOT-22 total score was significantly greater for dupilumab vs placebo at Weeks 24, 36, and 52 (all < 0.05). Improvements from baseline were significantly greater for dupilumab vs placebo at Week 52 for all SNOT-22 domains ( < 0.05), except emotion. At Week 52, significant changes from baseline with dupilumab vs placebo were observed for all 5 most important SNOT-22 items affecting their health (all < 0.05). EQ-VAS was significantly improved with dupilumab vs placebo by Week 12, with improvements sustained to Week 52 (all < 0.01). In patients with moderate-to-severe asthma who self-reported comorbid CRS, dupilumab treatment vs placebo improved CRS-specific HRQoL and general health status.
哮喘患者经常合并慢性鼻-鼻窦炎(CRS),伴或不伴鼻息肉,这增加了疾病负担并使治疗复杂化。这些事后分析在一项随机、安慰剂对照的QUEST研究(NCT02414854)中,调查了接受度普利尤单抗治疗的合并CRS的中重度哮喘患者特定疾病的健康相关生活质量(HRQoL)和总体健康状况。患者每2周接受300mg度普利尤单抗或安慰剂治疗,持续52周。CRS的HRQoL通过22项鼻-鼻窦结局测试(SNOT-22;各项目评分0-5)进行评估。这22个项目分为5个领域(鼻部、耳部/面部、睡眠、功能和情绪),患者报告影响其健康的最重要的前5个项目。总体健康状况通过欧洲五维度健康量表视觉模拟量表(EQ-VAS)进行评估。在1902例患者中,382例(20.1%)自述合并CRS;本分析纳入了193例接受300mg度普利尤单抗每2周一次或匹配安慰剂的患者。在基线时,受影响最大的SNOT-22领域是鼻部,总体健康状况低于人群规范。患者将“味觉/嗅觉减退”“鼻塞”“咳嗽”“生产力下降”和“醒来疲惫”评为影响其健康的5个最重要的SNOT-22项目。在第24周、36周和52周时,度普利尤单抗组SNOT-22总分较基线的百分比变化显著大于安慰剂组(均P<0.05)。在第52周时,除情绪领域外,度普利尤单抗组在所有SNOT-22领域较基线的改善均显著大于安慰剂组(P<0.05)。在第52周时,度普利尤单抗组与安慰剂组相比,影响其健康的所有5个最重要的SNOT-22项目较基线均有显著变化(均P<0.05)。与安慰剂相比,度普利尤单抗在第12周时使EQ-VAS显著改善,且改善持续至第52周(均P<0.01)。在自述合并CRS的中重度哮喘患者中,度普利尤单抗治疗与安慰剂相比改善了CRS特定的HRQoL和总体健康状况