Department of Pulmonary Medicine, Cliniques Universitaires Saint-Luc, Brussels, Belgium; Pneumology, ENT and Dermatology, Institute of Experimental and Clinical Research, UCLouvain, Brussels, Belgium.
Department of Biomedical Sciences, Humanitas University, Milan, Italy; Personalized Medicine, Asthma and Allergy Clinic, IRCCS Humanitas Research Hospital, Milan, Italy.
J Allergy Clin Immunol Pract. 2022 Oct;10(10):2646-2656. doi: 10.1016/j.jaip.2022.05.042. Epub 2022 Jun 24.
Patients with severe asthma may require maintenance oral corticosteroids (mOCS) for disease control as well as systemic corticosteroid (SCS) bursts for clinically significant exacerbations. However, mOCS and SCS use are associated with adverse effects, which increases patient disease burden.
To assess the real-world corticosteroid-sparing effect of mepolizumab in patients with severe asthma.
REALITI-A was a 24-month international, prospective, observational cohort study involving 84 centers across Europe, Canada, and the United States, with a 1-year pre-post mepolizumab treatment preplanned interim analysis. A total of 822 adults with a clinical diagnosis of asthma and a physician decision to initiate mepolizumab treatment (100 mg subcutaneously) were included. End points included daily mOCS dose at baseline (penultimate 28 days of pretreatment) and 1 year after treatment; percent reduction from baseline in mOCS dose; patients discontinuing mOCS 1 year after treatment; and the rate of clinically significant exacerbations (those requiring OCS for 3 days or more [or parenteral administration], emergency room visit, and/or hospital admission) before and after treatment.
A total of 319 patients received mOCS at baseline (median [interquartile range]: 10.0 [5.0-15.0] mg/d). At 1 year after treatment, median mOCS dose was reduced by 75% (2.5 [0.0-5.0] mg/d); 64% of patients had a reduction in mOCS dose of 50% or greater compared with baseline and 43% discontinued mOCS. Clinically significant exacerbations decreased between pretreatment and posttreatment (rate ratio [95% confidence interval] 0.29 [0.26-0.32]; P < .001).
This 1-year analysis demonstrates that real-world mepolizumab treatment is clinically effective in patients with severe asthma, providing disease control while reducing the need for mOCS and SCS bursts.
重度哮喘患者可能需要维持口服皮质类固醇（mOCS）以控制疾病，还需要全身皮质类固醇（SCS）冲击治疗以应对临床显著的加重。然而，mOCS 和 SCS 的使用会引起不良反应，从而增加患者的疾病负担。
评估美泊利珠单抗在重度哮喘患者中的实际皮质类固醇节约效应。
REALITI-A 是一项为期 24 个月的国际性、前瞻性、观察性队列研究，涉及欧洲、加拿大和美国的 84 个中心，在计划进行美泊利珠单抗治疗的 1 年期间进行了预先规划的中期分析。共纳入 822 名临床诊断为哮喘且医生决定启动美泊利珠单抗（皮下 100 mg）治疗的成年人。主要终点包括基线（预处理最后 28 天）和治疗 1 年后的每日 mOCS 剂量；mOCS 剂量从基线的降低百分比；治疗 1 年后停止使用 mOCS 的患者；以及治疗前后需要口服皮质类固醇治疗 3 天或以上（或采用胃肠外给药）、急诊就诊和/或住院的临床显著加重（哮喘加重）的发生率。
共有 319 名患者在基线时接受 mOCS 治疗（中位数[四分位间距]：10.0[5.0-15.0]mg/d）。治疗 1 年后，mOCS 剂量中位数降低 75%（2.5[0.0-5.0]mg/d）；与基线相比，64%的患者 mOCS 剂量降低 50%或更多，43%的患者停止使用 mOCS。治疗前后临床显著加重的发生率降低（发生率比[95%置信区间]0.29[0.26-0.32]；P<0.001）。
这项为期 1 年的分析表明，在重度哮喘患者中，真实世界中使用美泊利珠单抗治疗具有临床疗效，在控制疾病的同时减少了对 mOCS 和 SCS 冲击治疗的需求。
