Background

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.

Objective

To evaluate real-world effectiveness of asthma biologics and identify predictors of response.

Methods

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.

Results

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.

Conclusion

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.

中文翻译：

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哮喘生物制剂

背景

在现实世界中确认哮喘生物制剂的有效性是可取的，因为患者的特征和经历可能与随机对照试验中的不同。

客观的

评估哮喘生物制剂在现实世界中的有效性并确定反应的预测因子。

方法

我们对接受生物制剂的严重哮喘患者进行了一项回顾性研究。主要结果是与之前 12 个月相比，开始生物治疗后 12 个月临床显着恶化的变化。次要结果是严重恶化、维持口服皮质类固醇 (OCS) 剂量、支气管扩张剂前 1 秒用力呼气量 (FEV1) 和哮喘控制测试分数的变化。对生物学天真与否的受试者进行亚组分析。进行逐步逻辑回归模型以比较响应者与非响应者。

结果

共纳入 112 名患者。在12 _ _ _ _  _开始治疗后几个月。生物制剂还提高了支气管扩张剂前 FEV1 ( P  = .002) 和哮喘控制测试评分 ( P< .001)。先前使用另一种生物制剂的受试者在恶化频率、维持 OCS 剂量和哮喘控制方面也有显着改善。响应者更有可能是不吸烟者，基线 FEV1 较高，胃食管反流病和嗜酸性粒细胞计数大于 500 个细胞/μL。

结论

在现实世界中，哮喘的生物疗法可有效改善哮喘发作、哮喘控制和肺功能。对一种生物制剂反应不佳的患者仍然可以从使用不同生物制剂的治疗中受益。