Wechsler Michael E, Hickey Lisa, Garin Margaret, Chauhan Anoop
Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colo.
Teva Branded Pharmaceuticals R&D Inc., West Chester, Pa.
J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3434-3442.e4. doi: 10.1016/j.jaip.2020.06.009. Epub 2020 Jun 18.
Patients with severe eosinophilic asthma have increased risk of clinical asthma exacerbations (CAEs), impaired lung function, and lower quality of life (QoL) compared with patients with noneosinophilic asthma. The efficacy and safety of intravenous reslizumab have been demonstrated in 2 duplicate, randomized, double-blind, placebo-controlled, phase 3 studies.
We present findings from post hoc analyses of the subgroup of patients from the phase 3 studies with severe (Global Initiative for Asthma [GINA] Step 4 or 5) eosinophilic asthma who had ≥2 or ≥3 CAEs in the 12 months before screening.
Patients aged ≥12 years with severe eosinophilic asthma were randomized (1:1) to reslizumab 3.0 mg/kg or placebo every 4 weeks for 1 year. Outcomes assessed included CAEs, forced expiratory volume in 1 second (FEV), and Asthma Control Questionnaire 6 (ACQ-6) and Asthma QoL Questionnaire (AQLQ) scores.
Of 953 patients randomized, 318 (reslizumab: n = 156; placebo: n = 162) and 164 (reslizumab: n = 72; placebo: n = 92) were GINA 4/5 with ≥2 CAEs in the prior year and ≥3 CAEs in the prior year, respectively. Reslizumab significantly improved CAE rate, time to first CAE, and the proportion of patients who experienced ≥1 CAE versus placebo in both CAE subgroups. Improvements in FEV, ACQ-6 and AQLQ scores, and systemic corticosteroid burden were also observed with reslizumab versus placebo after 52 weeks of treatment in both CAE subgroups.
Reslizumab reduced CAE frequency and improved lung function, asthma control, and QoL versus placebo in patients with severe eosinophilic asthma with a high CAE rate before treatment.
与非嗜酸性粒细胞性哮喘患者相比，重度嗜酸性粒细胞性哮喘患者临床哮喘加重（CAE）风险增加、肺功能受损且生活质量（QoL）较低。静脉注射瑞利珠单抗的疗效和安全性已在2项重复、随机、双盲、安慰剂对照的3期研究中得到证实。
我们展示了对3期研究中重度（全球哮喘防治创议[GINA]第4或5级）嗜酸性粒细胞性哮喘患者亚组的事后分析结果，这些患者在筛查前12个月内有≥2次或≥3次CAE。
年龄≥12岁的重度嗜酸性粒细胞性哮喘患者被随机（1:1）分配，每4周接受3.0 mg/kg瑞利珠单抗或安慰剂治疗，为期1年。评估的结局包括CAE、1秒用力呼气量（FEV）、哮喘控制问卷6（ACQ-6）和哮喘生活质量问卷（AQLQ）评分。
在953例随机分组的患者中，分别有318例（瑞利珠单抗组：n = 156；安慰剂组：n = 162）和164例（瑞利珠单抗组：n = 72；安慰剂组：n = 92）为前一年有≥2次CAE和前一年有≥3次CAE的GINA 4/5级患者。在两个CAE亚组中，与安慰剂相比，瑞利珠单抗均显著改善了CAE发生率、首次发生CAE的时间以及经历≥1次CAE的患者比例。在两个CAE亚组中，治疗52周后，与安慰剂相比，瑞利珠单抗还观察到FEV、ACQ-6和AQLQ评分以及全身皮质类固醇负担的改善。
与安慰剂相比，瑞利珠单抗降低了治疗前CAE发生率高的重度嗜酸性粒细胞性哮喘患者的CAE频率，并改善了肺功能、哮喘控制和生活质量。
