Background: Having been approved for biological treatment of atopic dermatitis, dupilumab has also been recently licensed as add-on therapy for severe asthma and nasal polyposis. With regard to the latter diseases, few real-life clinical investigations have been carried out to date.
Objective: The primary end point of this single-center observational study was to evaluate in a real-life setting the short-term therapeutic effects of dupilumab in patients with severe asthma and nasal polyposis.
Methods: At baseline and after 4 weeks of add-on therapy with dupilumab, several clinical and functional parameters were assessed in 20 patients with severe asthma and nasal polyposis, including both allergic and nonallergic subjects.
Results: After 4 weeks of treatment with dupilumab, all patients experienced remarkable improvement in both severe asthma and nasal polyposis. In particular, asthma-control test and sinonasal outcome test 22 scores had significantly increased (p< 0.0001) and decreased (p< 0.0001), respectively. Oral corticosteroid intake got to zero within 4 weeks (p< 0.0001). Moreover, in week 4, significant increases were detected with regard to both prebronchodilator forced expiratory volume in the first second (p< 0.01) and forced vital capacity (FVC; p< 0.05). At the same time point, dupilumab had significantly reduced residual volume (p< 0.0001) and total lung capacity (p< 0.001), whereas it had enhanced forced midexpiratory flow of 25%– 75% FVC (p< 0.01) and peak expiratory flow (p< 0.01). After 4 weeks of treatment, dupilumab had also lowered levels of fractional exhaled nitric oxide (p< 0.0001).
Conclusion: The results of this real-life study suggest that dupilumab can be utilized in both allergic and nonallergic patients with severe asthma and nasal polyposis as a valuable add-on biological therapy with rapid onset of action.



中文翻译：

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重度哮喘和鼻息肉患者 Dupilumab 疗效的短期评估

背景： dupilumab 已被批准用于特应性皮炎的生物治疗，最近也被批准作为严重哮喘和鼻息肉病的附加疗法。关于后一种疾病，迄今为止很少进行实际的临床研究。
目的：这项单中心观察性研究的主要终点是在现实生活中评估 dupilumab 对严重哮喘和鼻息肉患者的短期治疗效果。
方法：在基线和使用 dupilumab 附加治疗 4 周后，对 20 名患有严重哮喘和鼻息肉病的患者（包括过敏性和非过敏性受试者）的几个临床和功能参数进行了评估。
结果：在用 dupilumab 治疗 4 周后，所有患者的严重哮喘和鼻息肉病均有显着改善。特别是哮喘控制测试和鼻腔鼻腔结果测试 22 分数分别显着增加（p < 0.0001）和减少（p < 0.0001）。口服皮质类固醇的摄入量在 4 周内降至零（p < 0.0001）。此外，在第 4 周，支气管扩张剂前第一秒用力呼气量 ( p < 0.01) 和用力肺活量 (FVC; p < 0.05) 均显着增加。在同一时间点，dupilumab 显着降低了残气量 ( p < 0.0001) 和总肺活量 ( p< 0.001)，而它增强了 25%–75% FVC ( p < 0.01) 的用力呼气中流速 (p < 0.01) 和呼气峰值流速 ( p < 0.01)。治疗 4 周后，dupilumab 还降低了呼出气一氧化氮的水平（p < 0.0001）。
结论：这项真实研究的结果表明，dupilumab 可用于过敏性和非过敏性严重哮喘和鼻息肉病患者，作为一种有价值的附加生物疗法，起效迅速。