D'Amato Maria, Menzella Francesco, Altieri Elena, Bargagli Elena, Bracciale Pietro, Brussino Luisa, Caiaffa Maria Filomena, Canonica Giorgio Walter, Caruso Cristiano, Centanni Stefano, De Michele Fausto, Di Marco Fabiano, Pastorello Elide Anna, Pelaia Girolamo, Rogliani Paola, Romagnoli Micaela, Schino Pietro, Senna Gianenrico, Vultaggio Alessandra, Ori Alessandra, Simoni Lucia, Boarino Silvia, Vitiello Gianfranco, Aliani Maria, Del Giacco Stefano
UOSD Malattie Respiratorie "Federico II", Ospedale Monaldi, AO Dei Colli, Napoli, Italy.
UOC Pneumologia, Ospedale "S. Valentino", Montebelluna (TV) - AULSS 2 Marca Trevigiana, Montebelluna, Italy.
Front Allergy. 2022 May 18;3:881218. doi: 10.3389/falgy.2022.881218. eCollection 2022.
Severe eosinophilic asthma (SEA) in the presence of chronic rhinosinusitis with nasal polyps (CRSwNP) indicates the presence of a more extensive eosinophilic inflammation. analyses from a pivotal clinical trial have demonstrated the enhanced efficacy of benralizumab on asthma outcomes in patients with CRSwNP as a comorbidity.
This is a analysis from the Italian multi-center observational retrospective ANANKE study. Patients were divided into two groups based on self-reported CRSwNP. Baseline clinical and laboratory features in the 12 months prior to benralizumab prescription were collected. Data of change over time of blood eosinophils, annualized exacerbations rates (AER), asthma control, lung function, oral corticosteroids (OCS) use, and benralizumab discontinuation were collected during the observation period.
At baseline, the 110 patients with CRSwNP were less frequently female (50.9% vs 74.2%) and obese (9.1% vs. 22.6%) with higher eosinophils (605 vs. 500 cells/mm) and OCS use when compared to patients without CRSwNP. Similar reductions of AER were seen (-95.8% vs. -91.5% for any exacerbation and -99.1% vs. -92.2% for severe exacerbations in patients with and without CRSwNP, respectively). During benralizumab treatment, comorbid SEA+CRSwNP was associated with a lower risk of any exacerbation ( = 0.0017) and severe exacerbations ( = 0.025). After a mean ± SD exposure of 10.3 ± 5.0 months, half of the SEA+CRSwNP patients eliminated OCS use. No discontinuation for safety reasons was recorded.
This study helped to confirm the baseline clinical features that distinguish patients with and without CRSwNP being prescribed benralizumab. Numerically enhanced OCS reduction and lower exacerbation risk were observed in patients with SEA and comorbid CRSwNP treated with benralizumab.
重度嗜酸性粒细胞性哮喘（SEA）合并慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）表明存在更广泛的嗜酸性粒细胞炎症。一项关键临床试验的分析表明，对于合并CRSwNP的患者，贝那利珠单抗对哮喘预后的疗效增强。
这是一项来自意大利多中心观察性回顾性ANANKE研究的分析。根据患者自我报告的CRSwNP情况将其分为两组。收集贝那利珠单抗处方前12个月的基线临床和实验室特征。在观察期内收集血液嗜酸性粒细胞随时间的变化数据、年化加重率（AER）、哮喘控制情况、肺功能、口服糖皮质激素（OCS）使用情况以及贝那利珠单抗停药情况。
在基线时，与无CRSwNP的患者相比，110例CRSwNP患者女性比例较低（50.9%对74.2%）、肥胖比例较低（9.1%对22.6%），嗜酸性粒细胞水平较高（605对500个细胞/mm）且OCS使用比例较高。两组患者的AER均有类似程度的降低（有和无CRSwNP的患者中，任何加重的AER分别降低-95.8%对-91.5%，重度加重的AER分别降低-99.1%对-92.2%）。在贝那利珠单抗治疗期间，合并SEA+CRSwNP与任何加重（P = 0.0017）和重度加重（P = 0.025）的风险较低相关。在平均±标准差为10.3±5.0个月的暴露期后，一半的SEA+CRSwNP患者停用了OCS。未记录因安全原因停药的情况。
本研究有助于确认区分接受贝那利珠单抗治疗的有和无CRSwNP患者的基线临床特征。在接受贝那利珠单抗治疗的SEA合并CRSwNP患者中，在数值上观察到OCS减少增强且加重风险降低。
