Department of Pneumology CHU Liége, GIGAI3, University of Liége, Liége, Belgium.
Respiratory Research Unit, Nottingham Respiratory NIHR BRC, University of Nottingham, Nottingham, UK; Global Medical Affairs, AstraZeneca, Cambridge, UK.
J Allergy Clin Immunol Pract. 2023 Jun;11(6):1759-1770.e7. doi: 10.1016/j.jaip.2023.03.009. Epub 2023 Mar 21.
The phase IIIb, randomized, parallel-group, placebo-controlled ANDHI double-blind (DB) study extended understanding of the efficacy of benralizumab for patients with severe eosinophilic asthma. Patients from ANDHI DB could join the 56-week ANDHI in Practice (IP) single-arm, open-label extension substudy.
Assess potential for standard-of-care background medication reductions while maintaining asthma control with benralizumab.
Following ANDHI DB completion, eligible adults were enrolled in ANDHI IP. After an 8-week run-in with benralizumab, there were 5 visits to potentially reduce background asthma medications for patients achieving and maintaining protocol-defined asthma control with benralizumab. Main outcome measures for non-oral corticosteroid (OCS)-dependent patients were the proportions with at least 1 background medication reduction (ie, lower inhaled corticosteroid dose, background medication discontinuation) and the number of adapted Global Initiative for Asthma (GINA) step reductions at end of treatment (EOT). Main outcomes for OCS-dependent patients were reductions in daily OCS dosage and proportion achieving OCS dosage of 5 mg or lower at EOT.
For non-OCS-dependent patients, 53.3% (n = 208 of 390) achieved at least 1 background medication reduction, increasing to 72.6% (n = 130 of 179) for patients who maintained protocol-defined asthma control at EOT. A total of 41.9% (n = 163 of 389) achieved at least 1 adapted GINA step reduction, increasing to 61.8% (n = 110 of 178) for patients with protocol-defined EOT asthma control. At ANDHI IP baseline, OCS dosages were 5 mg or lower for 40.4% (n = 40 of 99) of OCS-dependent patients. Of OCS-dependent patients, 50.5% (n = 50 of 99) eliminated OCS and 74.7% (n = 74 of 99) achieved dosages of 5 mg or lower at EOT.
These findings demonstrate benralizumab's ability to improve asthma control, thereby allowing background medication reduction.
IIIb 期、随机、平行组、安慰剂对照 ANDHI 双盲（DB）研究加深了对贝那鲁肽治疗重度嗜酸性粒细胞性哮喘患者疗效的理解。来自 ANDHI DB 的患者可以参加 56 周的 ANDHI 实践（IP）单臂、开放标签扩展子研究。
评估在维持贝那鲁肽控制哮喘的同时，减少标准治疗背景药物的潜力。
在 ANDHI DB 完成后，符合条件的成年人被招募到 ANDHI IP。在贝那鲁肽的 8 周导入期后，对于达到并维持协议定义的哮喘控制的患者，有 5 次就诊机会以减少背景哮喘药物。非口服皮质类固醇（OCS）依赖性患者的主要终点是至少有 1 种背景药物减少（即吸入皮质类固醇剂量降低，背景药物停药）的比例和治疗结束时（EOT）适应性全球哮喘倡议（GINA）步骤减少的数量。OCS 依赖性患者的主要结局是减少每日 OCS 剂量和达到 EOT 时 OCS 剂量为 5mg 或更低的比例。
对于非 OCS 依赖性患者，53.3%（n=390 中的 208）至少减少了 1 种背景药物，对于在 EOT 时维持协议定义的哮喘控制的患者，这一比例增加到 72.6%（n=179 中的 130）。共有 41.9%（n=389 中的 163）至少减少了 1 个适应性 GINA 步骤，对于在 EOT 时有协议定义的哮喘控制的患者，这一比例增加到 61.8%（n=178 中的 110）。在 ANDHI IP 基线时，40.4%（n=99 中的 40）的 OCS 依赖性患者的 OCS 剂量为 5mg 或更低。在 OCS 依赖性患者中，50.5%（n=99 中的 50）消除了 OCS，74.7%（n=99 中的 74）在 EOT 时达到了 5mg 或更低的剂量。
这些发现表明贝那鲁肽能够改善哮喘控制，从而允许减少背景药物。
