Stolz Daiana, Schuoler Claudio, Charbonnier Florian, Bridevaux Pierre-Olivier, Jandus Peter, Leuppi Jörg D, Pavlov Nikolay, Piecyk Andreas, Rothe Thomas
Pulmonology Clinic, University Hospital Basel, Basel, Switzerland.
Clinic of Respiratory Medicine and Faculty of Medicine, University of Freiburg, Freiburg, Germany.
J Asthma Allergy. 2024 Dec 24;17:1301-1312. doi: 10.2147/JAA.S495867. eCollection 2024.
Although studies have evaluated benralizumab, a monoclonal IL-5 receptor α antibody in severe eosinophilic asthma (SEA), in real-world settings, additional evidence is needed to further characterize its effectiveness in specific patient populations. Our study aimed to evaluate asthma control over 56 weeks in patients treated with benralizumab in Swiss real-world settings.
Conducted across 13 centres, this prospective, observational, non-interventional study involved 73 adults with physician confirmed SEA. Benralizumab 30 mg was administered according to the Swiss label at baseline and up to week 56. Primary outcome was the change in Asthma Control Questionnaire (ACQ-5) scores at week 8 compared to baseline. Exacerbations, use of oral corticosteroids (OCS), and lung function were assessed descriptively.
At baseline, the mean ACQ-5 score was 2.76 (SD 1.26), with 82.2% of patients showing not well-controlled asthma (ACQ-5 > 1.5). At week 8, the mean change in ACQ-5 compared to baseline was -0.95 (95% CI: -1.25, -0.66; p < 0.001). More than half of patients (59.1%) reached a clinically relevant improvement (MCID ≥ 0.5) at week 8, with 40.9% of patients doing so at week 1 and 87.2% at week 56. The annualized exacerbation rate (AER) of 3.65 (95% CI: 3.18, 4.18) at baseline was reduced to 0.68 (95% CI: 0.39, 1.19) at week 56. The relative reduction in AER from baseline to week 56 was 81.3%. Maintenance usage of OCS at baseline (median 25.0 mg/day) decreased over the study leading to a median change of 17.50 mg/day (95% CI: 10.0; 40.0) from baseline compared to week 56. The mean pre-bronchodilator FEV1 change from baseline to week 56 was 0.23 L (95% CI: 0.08; 0.38, p = 0.003).
Benralizumab demonstrated significant, rapid improvements in asthma control within one week of treatment initiation, with sustained benefits over 56 weeks.
尽管已有研究评估了抗白细胞介素-5受体α单克隆抗体贝那利珠单抗在重度嗜酸性粒细胞性哮喘（SEA）中的作用，但在真实世界环境中，仍需更多证据来进一步明确其在特定患者群体中的有效性。我们的研究旨在评估在瑞士真实世界环境中接受贝那利珠单抗治疗的患者56周内的哮喘控制情况。
这项前瞻性、观察性、非干预性研究在13个中心开展，纳入了73名经医生确诊为SEA的成年人。根据瑞士药品说明书，在基线期及直至第56周给予贝那利珠单抗30mg。主要结局是第8周时哮喘控制问卷（ACQ-5）评分相对于基线期的变化。对哮喘急性发作、口服糖皮质激素（OCS）的使用情况及肺功能进行了描述性评估。
基线期时，ACQ-5评分的均值为2.76（标准差1.26），82.2%的患者哮喘控制不佳（ACQ-5>1.5）。在第8周时，ACQ-5相对于基线期的平均变化为-0.95（95%置信区间：-1.25，-0.66；p<0.001）。超过半数的患者（59.1%）在第8周时达到了具有临床意义的改善（最小临床重要差异≥0.5），40.9%的患者在第1周时达到这一标准，87.2%的患者在第56周时达到。基线期时年化急性发作率（AER）为3.65（95%置信区间：3.18，4.18），在第56周时降至0.68（95%置信区间：0.39，1.19）。从基线期到第56周，AER的相对降低率为81.3%。基线期时OCS的维持用量（中位数25.0mg/天）在研究过程中减少，与第56周相比，相对于基线期的中位数变化为17.50mg/天（95%置信区间：10.0；40.0）。从基线期到第56周，支气管扩张剂使用前FEV1的平均变化为0.23L（95%置信区间：0.08；0.38，p=0.003）。
贝那利珠单抗在治疗开始后1周内即可显著、快速地改善哮喘控制情况，并在56周内持续获益。
