评估生物疗法在阿司匹林加重性呼吸道疾病中的真实世界疗效。
Appraisal of the Real-World Effectiveness of Biologic Therapies in Aspirin-Exacerbated Respiratory Disease.
机构信息
Division of Allergy, Asthma, and Immunology, Scripps Clinic, San Diego, Calif.
Scripps Health, Scripps Whittier Diabetes Institute, San Diego, Calif.
出版信息
J Allergy Clin Immunol Pract. 2022 Feb;10(2):478-484.e3. doi: 10.1016/j.jaip.2021.09.030. Epub 2021 Sep 28.
BACKGROUND
There are no head-to-head studies for patients with aspirin-exacerbated respiratory disease (AERD) comparing any of the 5 Food and Drug Administration-approved respiratory biologic therapies.
OBJECTIVE
Explore outcomes in subjects with AERD using biologic therapies in a real-world clinic setting.
METHODS
A retrospective pilot study was conducted for subjects with AERD who had been prescribed omalizumab (anti-IgE), mepolizumab (anti-IL-5), reslizumab (anti-IL-5), benralizumab (anti-IL-5 receptor alpha [anti-IL-5Rα]), or dupilumab (anti-IL-4 receptor alpha [anti-IL-4Rα]). Clinical outcomes pre- versus postinitiation of biologic therapy were explored including symptoms, 22-item sino-nasal outcome test scores, systemic corticosteroid and antibiotic prescriptions, and emergency room visits related to AERD.
RESULTS
Of the 74 subjects, 58.1% (n = 43) had used 1 biologic, though many (41.9%, n = 31) trialed more than 1 biologic. Of the 50 subjects who had used anti-IL-4Rα therapy, 98% (49 of 50) still had this therapy prescribed at study completion compared with 48.6% (17 of 35) and 26.9% (7 of 26) of those who used anti-IgE and anti-IL-5 and anti-IL-5 receptor alpha (anti-IL-5/IL-5Rα) therapy, respectively. Among those on anti-IL-4Rα therapy, there was a significant reduction in median total 22-item sino-nasal outcome test scores (51 to 19, P = .0002), corticosteroid bursts (2 to 0, P < .0001), and median number of antibiotic courses for respiratory disease (1 to 0, P = .0469) prebiologic versus postbiologic initiation. No statistically significant difference in those outcomes was observed for individuals on anti-IgE or anti-IL-5/IL-5Rα therapy.
CONCLUSIONS
Anti-IL-4Rα therapy led to significantly higher rates of clinical improvement in AERD when compared with anti-IL-5/IL-5Rα and anti-IgE biologic therapies. Prospective studies would help clarify best practices for the use of biologic therapies in AERD.
背景
对于阿司匹林加重的呼吸道疾病（AERD）患者，尚无任何一种食品和药物管理局批准的 5 种呼吸生物制剂疗法进行头对头比较的研究。
目的
在真实临床环境中，利用生物制剂探索 AERD 患者的结局。
方法
对接受奥马珠单抗（抗 IgE）、美泊利珠单抗（抗 IL-5）、瑞利珠单抗（抗 IL-5）、贝那利珠单抗（抗 IL-5 受体 α[抗 IL-5Rα]）或度普利尤单抗（抗 IL-4 受体 α[抗 IL-4Rα]）治疗的 AERD 患者进行回顾性试点研究。在开始使用生物制剂前后，探索了包括症状、22 项鼻-鼻窦结局测试评分、全身皮质类固醇和抗生素处方以及与 AERD 相关的急诊就诊在内的临床结局。
结果
在 74 例患者中，58.1%（n=43）使用了 1 种生物制剂，尽管许多患者（41.9%，n=31）尝试了超过 1 种生物制剂。在 50 例使用抗 IL-4Rα 治疗的患者中，98%（n=50）在研究结束时仍在接受该治疗，而使用抗 IgE 和抗 IL-5 以及抗 IL-5 受体 α（抗 IL-5/IL-5Rα）治疗的患者分别为 48.6%（n=17）和 26.9%（n=7）。在接受抗 IL-4Rα 治疗的患者中，22 项鼻-鼻窦结局测试评分中位数（从 51 分降至 19 分，P=0.0002）、皮质类固醇冲击中位数（从 2 次降至 0 次，P＜0.0001）和抗生素治疗呼吸道疾病中位数（从 1 次降至 0 次，P=0.0469）在开始生物制剂治疗前显著降低。而接受抗 IgE 或抗 IL-5/IL-5Rα 治疗的患者在这些结局上没有观察到统计学上的显著差异。
结论
与抗 IL-5/IL-5Rα 和抗 IgE 生物制剂治疗相比，抗 IL-4Rα 治疗可显著提高 AERD 的临床改善率。前瞻性研究将有助于阐明 AERD 中生物制剂治疗的最佳实践。
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