Ausín Pilar, Navarrete-Rouco María Eugenia, Carazo Luis, Sanchez-Trincado Jose Luis, Luzon Elisa, Nuevo Javier, Santín Mónica, Sánchez Jesús, Padilla-Galo Alicia
Pulmonology Department, Hospital del Mar, 08003 Barcelona, Spain.
Pharmacy Department, Hospital del Mar, 08003 Barcelona, Spain.
J Clin Med. 2025 Apr 26;14(9):3011. doi: 10.3390/jcm14093011.
Benralizumab has demonstrated rapid efficacy in treating severe eosinophilic asthma (SEA). This study aims to characterize early responses to benralizumab, the patient features observed in those with early responses, and the potential patient features that could predict them, and it also evaluates whether these improvements are sustained during a one-year follow-up (FUP) in clinical practice. This analysis was conducted using the ORBE II study database. ORBE II is an observational, retrospective study that included uncontrolled SEA adult patients treated with benralizumab according to routine clinical practice in Spain. We analysed patients with available data on the asthma control test (ACT) at baseline and within the first 120 days after benralizumab initiation, identifying ACT "Early Super-Responders" (ACT-ESR) as patients with a ≥9 point-improvement in the ACT score or reaching an absolute score of ≥24. Likewise, we assessed patients with available data on the pre-BD FEV during the same study periods, defining those with a pre-BD FEV increment of ≥230 mL as FEV-ESR patients. Clinical outcomes were described up to 1 year of FUP. A total of 45 and 65 patients with data for ACT and FEV, respectively, during the first 120 days of treatment were analysed. Of those, 55.5% and 58.5% of patients were categorized as ACT-ESR and FEV-ESR, respectively. At baseline, both groups showed high T2 inflammation markers and a high prevalence of comorbidities (chronic rhinosinusitis with nasal polyposis: 56% and 50%; gastro-oesophageal reflux disease: 24% and 40%, respectively). Poor asthma control (ACT < 20) was observed at baseline in 96% of ACT-ESR, while impaired lung function (pre-BD FEV < 80%) was present in 71.7% of FEV-ESR. Oral corticosteroid (OCS) dependency affected 25% and 30% of ACT-ESR and FEV-ESR, respectively. The early gains observed in ACT-ESR and FEV-ESR were sustained up to 1 year of FUP, with 90.5% and 66.7% of patients achieving a super-response (zero exacerbations and no OCS use) and 92.0% and 71.1% meeting clinical remission criteria (zero exacerbations, no OCS use, ACT ≥ 20 and pre-BD FEV increment of ≥100 mL), respectively. Benralizumab provides early benefits for SEA patients in clinical practice, with more than half achieving early super-responses in both ACT score and lung function. These improvements were sustained over a 1-year FUP, resulting in high rates of clinical remission.
贝那利珠单抗已在治疗重度嗜酸性粒细胞性哮喘（SEA）中显示出快速疗效。本研究旨在描述对贝那利珠单抗的早期反应、观察到早期反应的患者特征以及可预测这些反应的潜在患者特征，并且还评估这些改善在临床实践的一年随访（FUP）期间是否持续存在。该分析使用ORBE II研究数据库进行。ORBE II是一项观察性、回顾性研究，纳入了根据西班牙常规临床实践接受贝那利珠单抗治疗的未控制的SEA成年患者。我们分析了在基线以及贝那利珠单抗开始治疗后的前120天内有哮喘控制测试（ACT）可用数据的患者，将ACT“早期超级反应者”（ACT-ESR）定义为ACT评分改善≥9分或绝对评分达到≥24分的患者。同样，我们评估了在同一研究期间有支气管舒张前FEV可用数据的患者，将支气管舒张前FEV增加≥230 mL的患者定义为FEV-ESR患者。描述了直至FUP 1年的临床结局。分别分析了在治疗的前120天内有ACT和FEV数据的45例和65例患者。其中，分别有55.5%和58.5%的患者被归类为ACT-ESR和FEV-ESR。在基线时，两组均显示出高T2炎症标志物和高合并症患病率（慢性鼻-鼻窦炎伴鼻息肉：分别为56%和50%；胃食管反流病：分别为24%和40%）。在基线时，96%的ACT-ESR患者观察到哮喘控制不佳（ACT<20），而71.7%的FEV-ESR患者存在肺功能受损（支气管舒张前FEV<80%）。口服糖皮质激素（OCS）依赖分别影响25%和30%的ACT-ESR和FEV-ESR患者。在ACT-ESR和FEV-ESR中观察到的早期获益在FUP 1年期间持续存在，分别有90.5%和66.7%的患者实现超级反应（零加重且未使用OCS），以及92.0%和71.1%的患者符合临床缓解标准（零加重、未使用OCS、ACT≥20且支气管舒张前FEV增加≥100 mL）。在临床实践中，贝那利珠单抗为SEA患者提供了早期益处，超过一半的患者在ACT评分和肺功能方面均实现了早期超级反应。这些改善在1年的FUP期间持续存在，导致临床缓解率较高。
