Pulmonary and Critical Care Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Pulmonary and Critical Care Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York; Mary Parkes Center for Asthma, Allergy & Pulmonary Care, University of Rochester Medical Center, Rochester, New York.
Ann Allergy Asthma Immunol. 2021 Dec;127(6):655-660.e1. doi: 10.1016/j.anai.2021.08.416. Epub 2021 Sep 3.
Confirmation of effectiveness of asthma biologics in the real world is desirable because patient characteristics and experiences may differ from those included in randomized controlled trials.
To evaluate real-world effectiveness of asthma biologics and identify predictors of response.
We performed a retrospective study in patients with severe asthma receiving biologics. The primary outcome was change in clinically significant exacerbations at 12 months after starting biologic therapy, compared with 12 months before. Secondary outcomes were change in severe exacerbations, maintenance oral corticosteroid (OCS) dose, prebronchodilator forced expiratory volume in 1 second (FEV1), and asthma control test scores. Subgroup analyses were performed for subjects who were biologic naive or not. A stepwise logistic regression model was performed to compare responders to nonresponders.
A total of 112 patients were included. Biologic therapy was associated with a 59% reduction in clinically significant exacerbations (P < .001), 65% reduction in severe exacerbations (P < .001), and 54% reduction in maintenance OCS dose (P = .001) in the 12 months after starting therapy. Biologics also resulted in improvement in prebronchodilator FEV1 (P = .002) and Asthma Control Test score (P < .001). Subjects who were previously on another biologic also experienced significant improvements in exacerbation frequency, maintenance OCS dose, and asthma control. Responders were more likely to be nonsmokers and have higher baseline FEV1, gastroesophageal reflux disease, and eosinophil counts greater than 500 cells/μL.
In a real-world setting, biologic therapy in asthma is effective in improving exacerbations, asthma control, and lung function. Patients who have a suboptimal response to 1 biologic can still benefit from treatment with a different biologic.
在真实世界中确认哮喘生物制剂的疗效是理想的，因为患者的特征和体验可能与随机对照试验中包含的特征和体验不同。
评估哮喘生物制剂的真实世界疗效，并确定反应的预测因素。
我们对接受生物制剂治疗的重度哮喘患者进行了回顾性研究。主要结局是在开始生物治疗后 12 个月与治疗前 12 个月相比，临床显著恶化的变化。次要结局是严重恶化、维持口服皮质类固醇（OCS）剂量、支气管扩张前 1 秒用力呼气量（FEV1）和哮喘控制测试评分的变化。对生物制剂初治或非初治患者进行亚组分析。采用逐步逻辑回归模型比较反应者与无反应者。
共纳入 112 例患者。生物治疗后 12 个月，临床显著恶化减少 59%（P <.001），严重恶化减少 65%（P <.001），维持 OCS 剂量减少 54%（P =.001）。生物制剂还可改善支气管扩张前 FEV1（P =.002）和哮喘控制测试评分（P <.001）。之前使用过另一种生物制剂的患者也经历了恶化频率、维持 OCS 剂量和哮喘控制的显著改善。反应者更可能是非吸烟者，并且具有更高的基线 FEV1、胃食管反流病和嗜酸性粒细胞计数大于 500 个/μL。
在真实环境中，哮喘的生物治疗在改善恶化、哮喘控制和肺功能方面是有效的。对 1 种生物制剂反应不佳的患者仍可从不同生物制剂的治疗中受益。
