Cohen Family Asthma Institute and Department of Medicine.
Observational and Pragmatic Research Institute, Singapore.
Am J Respir Crit Care Med. 2024 Feb 1;209(3):262-272. doi: 10.1164/rccm.202305-0808OC.
Previous studies investigating the impact of comorbidities on the effectiveness of biologic agents have been relatively small and of short duration and have not compared classes of biologic agents. To determine the association between type 2-related comorbidities and biologic agent effectiveness in adults with severe asthma (SA). This cohort study used International Severe Asthma Registry data from 21 countries (2017-2022) to quantify changes in four outcomes before and after biologic therapy-annual asthma exacerbation rate, FEV% predicted, asthma control, and long-term oral corticosteroid daily dose-in patients with or without allergic rhinitis, chronic rhinosinusitis (CRS) with or without nasal polyps (NPs), NPs, or eczema/atopic dermatitis. Of 1,765 patients, 1,257, 421, and 87 initiated anti-IL-5/5 receptor, anti-IgE, and anti-IL-4/13 therapies, respectively. In general, pre- versus post-biologic therapy improvements were noted in all four asthma outcomes assessed, irrespective of comorbidity status. However, patients with comorbid CRS with or without NPs experienced 23% fewer exacerbations per year (95% CI, 10-35%; < 0.001) and had 59% higher odds of better post-biologic therapy asthma control (95% CI, 26-102%; < 0.001) than those without CRS with or without NPs. Similar estimates were noted for those with comorbid NPs: 22% fewer exacerbations and 56% higher odds of better post-biologic therapy control. Patients with SA and CRS with or without NPs had an additional FEV% predicted improvement of 3.2% (95% CI, 1.0-5.3; = 0.004), a trend that was also noted in those with comorbid NPs. The presence of allergic rhinitis or atopic dermatitis was not associated with post-biologic therapy effect for any outcome assessed. These findings highlight the importance of systematic comorbidity evaluation. The presence of CRS with or without NPs or NPs alone may be considered a predictor of the effectiveness of biologic agents in patients with SA.
先前研究生物制剂疗效与合并症的关联时，样本量相对较小，持续时间较短，且并未比较不同类别的生物制剂。本研究旨在确定 2 型相关合并症与成人严重哮喘（SA）患者接受生物制剂治疗效果的关联。这项队列研究利用了来自 21 个国家（2017-2022 年）的国际严重哮喘登记处数据，量化了生物治疗前后四类结局的变化：哮喘恶化年发生率、FEV%预计值、哮喘控制情况和长期口服皮质类固醇日剂量，比较了合并过敏性鼻炎、伴有或不伴鼻息肉（NP）的慢性鼻-鼻窦炎（CRS）、NP 或特应性皮炎/湿疹的患者与不合并这些疾病的患者。在 1765 名患者中，分别有 1257 名、421 名和 87 名患者起始了抗白细胞介素-5/5 受体、抗 IgE 和抗白细胞介素-4/13 治疗。总体而言，无论合并症状态如何，在所有评估的四种哮喘结局中，患者在接受生物治疗前后均有改善。然而，与不伴有 CRS 或 NP 的患者相比，伴有或不伴有 NP 的 CRS 患者每年的哮喘恶化次数减少了 23%（95%CI，10-35%； <0.001），且接受生物治疗后哮喘控制改善的几率更高（95%CI，26-102%； <0.001）。伴有 NP 的患者也有类似的估计值：哮喘恶化次数减少 22%，且接受生物治疗后控制改善的几率更高（56%）。伴有 SA 和 CRS 或 NP 的患者的 FEV%预计值进一步增加了 3.2%（95%CI，1.0-5.3； = 0.004），伴有 NP 的患者也有类似的趋势。过敏性鼻炎或特应性皮炎的存在与任何评估的生物治疗后效果均无关联。这些发现强调了系统评估合并症的重要性。伴有 CRS 或 NP 或 NP 本身可能被视为预测 SA 患者生物制剂疗效的指标。
