Panettieri Reynold A, Lugogo Njira, Moore Wendy C, Chipps Bradley E, Jepson Brett, Zhou Wenjiong, Ambrose Christopher S, Genofre Eduardo, Carstens Donna D
Rutgers, The State University of New Jersey, 89 French Street Suite 4211, New Brunswick, NJ, 08901, United States.
University of Michigan, 380 Parkland Plaza Ste 210 Floor 2, Ann Arbor, MI, 48103, United States.
Respir Med. 2023 Sep;216:107285. doi: 10.1016/j.rmed.2023.107285. Epub 2023 Jun 7.
Patients with eosinophilic severe asthma (SA) have an increased risk of asthma exacerbations. Benralizumab is approved for eosinophilic SA, and there is great value in understanding real-world effectiveness.
The aim of this analysis was to examine the effectiveness of benralizumab in a real-world cohort of subspecialist-treated US patients with eosinophilic SA.
CHRONICLE is an ongoing, noninterventional study of subspecialist-treated US adults with SA receiving biologics, maintenance systemic corticosteroids, or those persistently uncontrolled by high-dose inhaled corticosteroids with additional controllers. For this analysis, eligible patients enrolled from February 2018 to February 2021, had received ≥ 1 dose of benralizumab, and had study data for ≥ 3 months before and after benralizumab initiation. The primary analysis included patients with prior exacerbations reported and 12 months of outcomes data before and after initiation. Patient outcomes occurring 6-12 months before and after initiation were also evaluated.
A total of 317 patients had ≥ 3 months of follow-up before and after first benralizumab dose. For patients with 12 months (n = 107) and 6-12 months (n = 166) of data, significant reductions were observed in annualized rates of exacerbations (62%; P < 0.001 and 65%; P < 0.001, respectively), with similar reductions in the rates of hospitalizations and emergency department visits. Benralizumab recipients with blood eosinophil counts (BEC) of ≥ 300/ μL and < 300/ μL at baseline and 12 months of data also had significant reductions in exacerbations (68%; P < 0.001, 61%; P < 0.001).
This real-world, noninterventional analysis reinforces the clinical value of benralizumab in the management of patients with eosinophilic SA.
嗜酸性粒细胞性重度哮喘（SA）患者哮喘急性加重的风险增加。贝那利珠单抗已被批准用于治疗嗜酸性粒细胞性SA，了解其在现实世界中的有效性具有重要价值。
本分析旨在研究贝那利珠单抗在接受专科治疗的美国嗜酸性粒细胞性SA患者的真实队列中的有效性。
CHRONICLE是一项正在进行的非干预性研究，研究对象为接受专科治疗的美国成年SA患者，这些患者正在接受生物制剂、维持性全身糖皮质激素治疗，或那些使用高剂量吸入性糖皮质激素及其他控制药物仍持续未得到控制的患者。对于本分析，符合条件的患者于2018年2月至2021年2月入组，接受了≥1剂贝那利珠单抗治疗，且在开始使用贝那利珠单抗之前和之后有≥3个月的研究数据。主要分析包括报告有既往急性加重的患者以及开始使用贝那利珠单抗之前和之后12个月的结局数据。还评估了开始使用贝那利珠单抗之前和之后6 - 12个月出现的患者结局。
共有317例患者在首次使用贝那利珠单抗之前和之后有≥3个月的随访。对于有12个月（n = 107）和6 - 12个月（n = 166）数据的患者，急性加重的年化率显著降低（分别为62%；P < 0.001和65%；P < 0.001），住院率和急诊就诊率也有类似程度的降低。在基线和有12个月数据时血液嗜酸性粒细胞计数（BEC）≥300/μL和<300/μL的贝那利珠单抗接受者的急性加重情况也显著减少（分别为68%；P < 0.001，61%；P < 0.001）。
这项真实世界的非干预性分析强化了贝那利珠单抗在嗜酸性粒细胞性SA患者管理中的临床价值。
