Wake Forest School of Medicine, Winston-Salem, North Carolina.
Rutgers, The State University of New Jersey, New Brunswick, New Jersey.
Ann Allergy Asthma Immunol. 2020 Sep;125(3):294-303.e1. doi: 10.1016/j.anai.2020.04.004. Epub 2020 Apr 15.
Severe asthma (SA) often requires subspecialist management and treatment with biologic therapies or maintenance systemic corticosteroids (mSCS).
To describe contemporary, real-world biologic and mSCS use among US subspecialist-treated patients with SA.
CHRONICLE is an ongoing, noninterventional study of US adults with SA treated by allergists/immunologists or pulmonologists. Eligible patients are receiving biologics or mSCS or are uncontrolled on high-dosage inhaled corticosteroids with additional controllers. Biologic and mSCS use patterns and patient characteristics were summarized for patients enrolled between February 2018 and February 2019.
Among protocol-eligible patients, 58% and 12% were receiving biologics and mSCS, respectively, with 7% receiving both. Among 796 enrolled, most were women (67%), non-Hispanic white (71%), of suburban residence (50%), and had elevated body mass index (median: 31). Respiratory and nonrespiratory comorbidities were highly prevalent. With biologics (n = 557), 51% were anti-immunoglobulin E and 48% were anti-interleukin (IL)-5/IL-5Rα; from May 2018, 76% of initiations were anti-IL-5/IL-5Rα. In patients receiving mSCS, median prednisone-equivalent daily dose was 10 mg. Multivariate logistic regression found that patients of hospital clinics, sites with fewer nonphysician staff, and with a recorded concurrent chronic obstructive pulmonary disease diagnosis were less likely to receive biologics and more likely to receive mSCS.
In this real-world sample of US subspecialist-treated patients with SA not controlled by high-dosage inhaled corticosteroids with additional controllers, mSCS use was infrequent and biologic use was common, with similar prevalence of anti-immunoglobulin E and anti-IL-5/IL-5Rα biologics. Treatment differences associated with patient and site characteristics should be investigated to ensure equitable access to biologics and minimize mSCS use.
ClinicalTrials.gov Identifier: NCT03373045.
重度哮喘（SA）通常需要专科医生进行管理和治疗，并使用生物制剂或维持性全身皮质类固醇（mSCS）。
描述美国专科医生治疗的 SA 患者中，当前真实世界使用生物制剂和 mSCS 的情况。
CHRONICLE 是一项正在进行的、非干预性的美国成人 SA 研究，入组患者由过敏免疫学家或肺病学家治疗。符合条件的患者正在接受生物制剂或 mSCS 治疗，或在吸入高剂量皮质类固醇的基础上联合其他控制药物后仍未得到控制。对 2018 年 2 月至 2019 年 2 月期间入组的患者，总结了生物制剂和 mSCS 的使用模式和患者特征。
在符合方案的患者中，分别有 58%和 12%的患者正在接受生物制剂和 mSCS 治疗，7%的患者同时接受这两种治疗。在 796 名入组患者中，大多数为女性（67%）、非西班牙裔白人（71%）、居住在郊区（50%）、体重指数偏高（中位数：31）。患者普遍存在呼吸道和非呼吸道合并症。在接受生物制剂（n=557）治疗的患者中，51%接受的是抗免疫球蛋白 E 治疗，48%接受的是抗白细胞介素（IL）-5/IL-5Rα治疗；自 2018 年 5 月以来，76%的起始治疗为抗 IL-5/IL-5Rα治疗。接受 mSCS 治疗的患者中，泼尼松等效日剂量中位数为 10 mg。多变量逻辑回归发现，来自医院诊所的患者、非医师工作人员较少的站点以及有同时记录的慢性阻塞性肺疾病诊断的患者，不太可能接受生物制剂治疗，而更有可能接受 mSCS 治疗。
在该真实世界的美国专科医生治疗的重度哮喘患者样本中，未能通过吸入高剂量皮质类固醇联合其他控制药物得到控制的患者中，mSCS 的使用并不常见，而生物制剂的使用则较为常见，抗免疫球蛋白 E 和抗 IL-5/IL-5Rα 生物制剂的使用比例相似。应研究与患者和治疗站点特征相关的治疗差异，以确保生物制剂的公平使用并尽量减少 mSCS 的使用。
ClinicalTrials.gov 标识符：NCT03373045。
