Lugogo Njira L, Soler Xavier, Gon Yasuhiro, Côté Andréanne, Hilberg Ole, Xia Changming, Zhang Yi, de Prado Gómez Lucía, Rowe Paul J, Radwan Amr, Jacob-Nara Juby A, Deniz Yamo, Peters Anju T
University of Michigan Medical School, 300 North Ingalls Street, Suite 2C40, Ann Arbor, MI, 48109, USA.
Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Adv Ther. 2025 Feb;42(2):849-862. doi: 10.1007/s12325-024-03051-0. Epub 2024 Dec 9.
Patients with uncontrolled, moderate-to-severe asthma have a higher risk for exacerbations, negatively impacting lung function and quality of life. Dupilumab, a fully human monoclonal antibody, blocks interleukins 4 and 13, key and central drivers of type 2 inflammation. Dupilumab has been effective in the treatment of certain types of moderate-to-severe asthma across several clinical trials. We describe the characteristics of patients enrolled in RAPID, a global prospective registry, who initiated dupilumab (primary indication: asthma) in a real-world clinical setting.
A total of 205 patients (aged ≥ 12 years) were enrolled between March 2020 and October 2021 and are included in this analysis. Data are shown as mean (SD) unless stated otherwise.
Patients were aged 50.1 (17.4) years and were mostly female (65.4%) and white (74.1%). At enrollment, 24.4% reported being current/former smokers and 86.8% had moderate-to-severe asthma (Global Initiative for Asthma steps 3-5). A mean (SD) of 4.4 (6.4) severe asthma exacerbations were reported in the year before enrolling in the registry in 78 of 152 patients with available data. Patients had reduced lung function [pre-bronchodilator forced expiratory volume in 1 s (FEV): 2.3 (1.1) L; pre-bronchodilator percent predicted FEV: 70.3 (20.3) %] and poor asthma control [6-item Asthma Control Questionnaire: 2.4 (1.2); Asthma Quality of Life Questionnaire: 4.1 (1.3)]. The median (Q1-Q3) blood eosinophil count was 305 (200-695) cells/µL and the mean (SD) fractional exhaled nitric oxide levels were 42 (35) ppb (range: 4-186 ppb).
Our findings suggest that most patients who enrolled in RAPID and initiated dupilumab in real-world clinical settings had a high disease burden, despite receiving current standard-of-care treatment at enrollment.
中重度哮喘控制不佳的患者病情加重风险更高,这对肺功能和生活质量产生负面影响。度普利尤单抗是一种全人源单克隆抗体,可阻断白细胞介素4和13,这两种细胞因子是2型炎症的关键驱动因素。在多项临床试验中,度普利尤单抗已被证明可有效治疗某些类型的中重度哮喘。我们描述了在一项全球前瞻性登记研究RAPID中登记的患者特征,这些患者在真实临床环境中开始使用度普利尤单抗(主要适应症:哮喘)。
2020年3月至2021年10月期间共纳入205例年龄≥12岁的患者,并纳入本分析。除非另有说明,数据以均值(标准差)表示。
患者年龄为50.1(17.4)岁,大多数为女性(65.4%),白人(74.1%)。入组时,24.4%的患者报告为当前/既往吸烟者,86.8%的患者患有中重度哮喘(全球哮喘防治创议3-5级)。在152例有可用数据的患者中,78例在登记前一年平均(标准差)报告有4.4(6.4)次严重哮喘发作。患者肺功能下降[支气管扩张剂前1秒用力呼气容积(FEV):2.3(1.1)L;支气管扩张剂前预测FEV百分比:70.3(20.3)%],哮喘控制不佳[6项哮喘控制问卷:2.4(1.2);哮喘生活质量问卷:4.1(1.3)]。血液嗜酸性粒细胞计数中位数(四分位数间距)为305(200-695)个/µL,平均(标准差)呼出一氧化氮分数水平为42(35)ppb(范围:4-186 ppb)。
我们的研究结果表明,尽管在入组时接受了当前的标准治疗,但大多数在真实临床环境中登记并开始使用度普利尤单抗的患者疾病负担仍然很高。