Personalized Medicine, Asthma and Allergy, Humanitas University and Research Hospital IRCCS, Milan, Italy.
Department of Respiratory Diseases, University of Montpellier, Montpellier, France.
J Allergy Clin Immunol Pract. 2022 Jun;10(6):1515-1526. doi: 10.1016/j.jaip.2022.02.026. Epub 2022 Mar 6.
Type 2 inflammatory diseases often coexist in patients. Dupilumab targets type 2 inflammation and has demonstrated treatment benefits in patients with atopic dermatitis (AD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP) with an acceptable safety profile.
This post hoc analysis across five phase 3 studies in patients with moderate to severe AD or asthma, or severe CRSwNP, evaluated time of onset and duration of the treatment response.
Patients received subcutaneous dupilumab 200/300 mg or placebo. Assessments included the Eczema Area and Severity Index, Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index in AD; pre-bronchodilator FEV, daily morning peak expiratory flow, and symptom scores in asthma; and University of Pennsylvania Smell Identification Test, daily nasal congestion, and loss of smell scores in CRSwNP.
At week 2 after the initiation of dupilumab versus placebo, 67.8% versus 36.5% of AD patients achieved a clinically meaningful benefit (Eczema Area and Severity Index: 50% or greater improvement; Peak Pruritus Numerical Rating Scale: 3 point or greater improvement; or Dermatology Life Quality Index: 4 point or greater improvement) (P < .001). Moreover, 61.6% versus 39.9% of asthma patients achieved improvements in pre-bronchodilator FEV of 100 mL or greater and 48.8% versus 26.3% achieved 200 mL or greater improvement (both P < .001); 33.2% versus 5.6% of CRSwNP patients regained a sense of smell (P < .001). Treatment effects further improved or were sustained to the end of treatment.
Clinically meaningful responses were achieved rapidly after the first dupilumab dose in AD, asthma, or CRSwNP and were sustained throughout treatment (see Video in this article's Online Repository at www.jaci-inpractice.org).
2 型炎症性疾病常同时存在于患者中。度普利尤单抗针对 2 型炎症，在特应性皮炎（AD）、哮喘和伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）患者中显示出治疗益处，且具有可接受的安全性。
这项在 5 项 3 期研究中的事后分析，评估了中重度 AD 或哮喘患者或重度 CRSwNP 患者在接受度普利尤单抗 200/300mg 或安慰剂治疗后的起效时间和治疗应答持续时间。
患者接受度普利尤单抗 200/300mg 或安慰剂皮下注射。AD 患者的评估包括湿疹面积和严重程度指数（Eczema Area and Severity Index，EASI）、瘙痒峰值数字评分量表（Peak Pruritus Numerical Rating Scale，PPNS）和皮肤病生活质量指数（Dermatology Life Quality Index，DLQI）；哮喘患者的评估包括预用药后用力呼气量（forced expiratory volume in one second，FEV1）、每日清晨呼气峰值流量和症状评分；CRSwNP 患者的评估包括宾夕法尼亚大学嗅觉识别测试（University of Pennsylvania Smell Identification Test，UPSIT）、每日鼻塞和嗅觉丧失评分。
在开始度普利尤单抗治疗后第 2 周，67.8%的 AD 患者与 36.5%的安慰剂组患者达到临床有意义的改善（EASI：改善 50%或更多；PPNS：改善 3 分或更多；或 DLQI：改善 4 分或更多）（P <.001）。此外，61.6%的哮喘患者与 39.9%的安慰剂组患者达到预用药后 FEV1 改善 100ml 或更多，48.8%的患者达到 200ml 或更多的改善（均 P <.001）；33.2%的 CRSwNP 患者与 5.6%的安慰剂组患者恢复嗅觉（P <.001）。治疗效果进一步改善或在整个治疗期间持续。
AD、哮喘或 CRSwNP 患者在接受度普利尤单抗首剂后迅速出现有临床意义的应答，且应答在整个治疗期间得以维持（详见本文在线知识库中本文视频）。
