Mullol J, Lund V J, Wagenmann M, Han J K, Sousa A N, Smith S G, Mayer B, Chan R H, Fokkens W J
Department of Otorhinolaryngology, Hospital Clinic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.
University College London, London, UK;Royal National Throat Nose and Ear Hospital, UCLH, London, UK.
Rhinology. 2024 Jun 1;62(3):320-329. doi: 10.4193/Rhin22.416.
Loss of smell is one of the most bothersome and difficult-to-treat symptoms in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP).
SYNAPSE was a 52-week Phase III study of 4-weekly mepolizumab (100 mg subcutaneously) plus standard of care in adults with severe bilateral CRSwNP. This post hoc analysis assessed changes from baseline to study end in loss of smell visual analogue scale (VAS) symptom score, in patients stratified by several baseline clinical characteristics. SinoNasal Outcomes Test (SNOT)-22 sense of smell/taste item and University of Pennsylvania Smell Identification Test (UPSIT) scores were also assessed.
SYNAPSE enrolled 407 patients (mepolizumab=206; placebo=201) with impaired sense of smell at baseline. Improvements from baseline to study end in loss of smell VAS score were greater with mepolizumab versus placebo (treatment difference: -0.37) and most notable in patients with fewer or more recent prior surgeries (treatment difference: 1 vs 2 vs more than 2 prior surgeries,-1.29 vs -0.23 vs -0.07; =3 years since last surgery, -.89 vs 0.22). Approximately 25% of patients had baseline UPSIT scoresavailable; among those scoring =19 by study end. The SNOT-22 sense of smell/taste item score improved with mepolizumab versus placebo.
Mepolizumab treatment improved patients' perceived sense of smell, as measured by loss of smell VAS score and SNOT-22 sense of smell/taste item score in patients with severe refractory CRSwNP.
嗅觉丧失是重度慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）患者最困扰且最难治疗的症状之一。
SYNAPSE是一项为期52周的III期研究，对患有重度双侧CRSwNP的成人患者每4周皮下注射100mg美泊利单抗并联合标准治疗。这项事后分析评估了根据几种基线临床特征分层的患者从基线到研究结束时嗅觉视觉模拟量表（VAS）症状评分的变化。还评估了鼻鼻窦结局测试（SNOT）-22嗅觉/味觉项目和宾夕法尼亚大学嗅觉识别测试（UPSIT）评分。
SYNAPSE研究纳入了407例基线时嗅觉受损的患者（美泊利单抗组=206例；安慰剂组=201例）。与安慰剂相比，美泊利单抗组从基线到研究结束时嗅觉VAS评分的改善更大（治疗差异：-0.37），在既往手术次数较少或较近的患者中最为显著（治疗差异：既往手术1次、2次和超过2次，-1.29 vs -0.23 vs -0.07；距上次手术≥3年，-0.89 vs 0.22）。约25%的患者有基线UPSIT评分；在这些患者中，到研究结束时得分≥19分。与安慰剂相比，美泊利单抗组SNOT-22嗅觉/味觉项目评分有所改善。
在重度难治性CRSwNP患者中，通过嗅觉VAS评分和SNOT-22嗅觉/味觉项目评分衡量，美泊利单抗治疗改善了患者的嗅觉感知。
