Department of Medicine, NYU Langone Health, New York, New York.
Department of Medicine, Loma Linda University Health, Loma Linda, California.
Ann Allergy Asthma Immunol. 2021 Sep;127(3):318-325.e2. doi: 10.1016/j.anai.2021.03.015. Epub 2021 Mar 26.
Patients with severe asthma may remain uncontrolled despite biologic therapy in addition to standard therapy, but this disease burden has not been quantified.
To estimate the clinical and economic burden in a US national sample.
Patients who have severe asthma with indicated biologic treatment (earliest use = index date) were selected from the MarketScan database between January 1, 2013, and June 30, 2018. Inclusion criteria were continuous enrollment for 12 months postindex with a minimum of 2 biologic fills, greater than or equal to 12 years of age, evidence of medium- to high-dose inhaled corticosteroids and long-acting β-agonist combination before the index, and absence of other respiratory diagnoses and malignancies. Disease exacerbations (used to classify asthma control), health care costs, and treatment characteristics were reported during the 12-month postindex period.
The sample included 3262 biologic patients; 88% with anti-immunoglobulin E therapy (omalizumab) and 12% non-anti-immunoglobulin E (reslizumab, mepolizumab, benralizumab). The mean age was 49 (±15) years; 64% were women. Prescriptions included inhaled corticosteroids and long-acting β-agonist (82%), systemic corticosteroids (76%), and leukotriene receptor antagonists (68%). Notably, 63% of patients presented greater than or equal to 1 asthma exacerbation (mean 1.3 per patient/year). Furthermore, 35% of patients were categorized as having controlled asthma, whereas 28% were suboptimally controlled and 29% were uncontrolled. Patients with uncontrolled disease had higher all-cause and asthma-related costs ($69,206 and $45,693, respectively) than patients with suboptimally controlled ($59,407 and $40,793, respectively) or controlled disease ($53,083 and $38,393, respectively). Furthermore, 62% of newly treated patients were persistent with their index biologic.
Biologic therapies are effective in reducing exacerbations, but a substantial proportion of patients with severe asthma treated with current biologics continue to experience uncontrolled disease, highlighting a remaining unmet need for patients with severe uncontrolled asthma.
尽管在标准治疗之外还使用了生物疗法，但仍有部分重度哮喘患者病情无法得到控制，但目前尚未对这种疾病负担进行量化评估。
在一个美国全国性样本中评估临床和经济负担。
从 MarketScan 数据库中选取了 2013 年 1 月 1 日至 2018 年 6 月 30 日期间接受过有指征的生物治疗（最早使用日期=索引日期）的重度哮喘患者。纳入标准为索引后 12 个月内连续入组且至少有 2 次生物制剂使用、年龄大于或等于 12 岁、索引前有中至高剂量吸入皮质激素和长效 β-激动剂联合治疗的证据，并且没有其他呼吸道诊断和恶性肿瘤。报告了索引后 12 个月期间的疾病加重（用于分类哮喘控制情况）、医疗保健费用和治疗特征。
该样本共纳入 3262 名生物制剂患者；88%接受了抗免疫球蛋白 E 治疗（奥马珠单抗），12%接受了非抗免疫球蛋白 E 治疗（瑞利珠单抗、美泊利珠单抗、贝那利珠单抗）。患者平均年龄为 49（±15）岁，64%为女性。处方包括吸入皮质激素和长效β-激动剂（82%）、全身皮质激素（76%）和白三烯受体拮抗剂（68%）。值得注意的是，63%的患者出现了大于或等于 1 次哮喘加重（平均每位患者每年 1.3 次）。此外，35%的患者被归类为哮喘得到控制，28%的患者控制不理想，29%的患者未得到控制。未得到控制疾病患者的全因和哮喘相关费用均高于控制不理想（分别为 69206 美元和 45693 美元）和控制良好（分别为 53083 美元和 38393 美元）患者。此外，62%的新治疗患者对其指数生物制剂持续治疗。
生物疗法在减少加重方面是有效的，但目前使用生物疗法治疗的重度哮喘患者中仍有相当一部分患者病情未得到控制，这突显了重度未控制哮喘患者仍存在未满足的治疗需求。
