背景:这项研究的目的是评估,贝那利珠单抗在慢性鼻-鼻窦炎伴鼻息肉病(CRSwNP)未控制的重度哮喘患者中的临床获益.方法:该研究纳入了与CRSwNP相关的未控制的重度哮喘患者,这些患者开始用贝那利珠单抗治疗。肺功能,嗜酸性粒细胞增多,IgE,合并症,哮喘控制测试(ACT)的变化,哮喘控制问卷(ACQ),视觉模拟量表(VAS),生活质量(AQLQ)VAS(阻塞,drip,嗅觉缺失,面部压力),SNOT-22,减少或停药类固醇和其他药物,分析了入院和急诊就诊情况。FEOS量表和EXACTO用于反应评估。结果:我们分析了58名在12个月时完成最低限度治疗的患者。用贝那利珠单抗治疗后,恶化减少了82%(p<0.001),类固醇周期下降84%(p<0.001),急诊就诊83%p<0.001),入院率76%(p<0.001),改善哮喘控制的所有量表,(p<0.001)。就肺功能而言,在FVC%中观察到差异(p<0.001),FEV1%(p<0.001),和FEV1/FVC%(69.5±10vs.74±10,p<0.001)。关于CRSwNP,在SNOT-22中观察到差异(54.66±17vs.20.24±9,p<0.001),VAS阻塞(7.91±1vs.1.36±1,p<0。001),VAS点滴(7.76±1vs.1.38±1,p<0.001),VAS失语症(7.66±1vs.1.38±1,p<0.001)和VAS面部压力(7.91±1vs.1.22±1,p<0.001)。治疗后的平均FEOS评分为73±14。33例患者(57%)达到完全应答/超应答,16例(28%)反应良好,9例(15%)部分反应良好。结论:贝那利珠单抗对与CRSwNP相关的未控制的重度哮喘患者的给药已被证明可以改善鼻部症状,哮喘控制和肺功能。这导致对口服类固醇的需求减少,维护和抢救药物,急诊室探视,和住院,57%的患者达到临床缓解标准。
Background: The objective of this study was to evaluate, the clinical benefit of benralizumab in patients with uncontrolled severe asthma associated with chronic rhinosinusitis with nasal
polyposis (CRSwNP). Methods: The study included patients with uncontrolled severe asthma associated with CRSwNP who started therapy with benralizumab. Pulmonary function, eosinophilia, IgE, comorbidity, changes in the Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Visual Analogue Scale (VAS), Quality of Life (AQLQ), VAS (obstruction, drip, anosmia, facial pressure), SNOT-22, decrease or withdrawal of steroids and other medication, hospital admissions and emergency visits were analysed. The FEOS scale and EXACTO were employed in the assessment of response. Results: We analyzed 58 patients who completed minimal treatment at 12 months. After treatment with benralizumab, exacerbations were reduced by 82% (p < 0.001), steroid cycles by 84% (p < 0.001), emergencies visit by 83% p < 0.001) and admissions by 76% (p < 0.001), improving all the scales for asthma control, (p < 0.001). In terms of lung function, differences were observed in FVC% (p < 0.001), FEV1% (p < 0.001), and FEV1/FVC% (69.5 ± 10 vs. 74 ± 10, p < 0.001). In relation to CRSwNP, differences were observed in SNOT-22 (54.66 ± 17 vs. 20.24 ± 9, p < 0.001), VAS obstruction (7.91 ± 1 vs. 1.36 ± 1, p < 0. 001), VAS drip (7.76 ± 1 vs. 1.38 ± 1, p < 0.001), VAS anosmia (7.66 ± 1 vs. 1.38 ± 1, p < 0.001) and VAS facial pressure (7.91 ± 1 vs. 1.22 ± 1, p < 0.001). The mean FEOS score after treatment was 73 ± 14. A complete response/super response was achieved in 33 patients (57%), good response in 16 (28%) and partial response in 9 (15%). Conclusions: The administration of benralizumab to patients with uncontrolled severe asthma associated with CRSwNP has been demonstrated to improve nasal symptoms, asthma control and lung function. This resulted in a reduction in the need for oral steroids, maintenance and rescue medication, emergency room visits, and hospital admissions, with 57% of patients achieving the clinical remission criteria.