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乌帕替尼治疗特应性皮炎患者的疗效,包括对度普利尤单抗和/或巴瑞替尼应答不足的患者:来自 BioDay 登记研究的结果。

Effectiveness of Upadacitinib in Patients with Atopic Dermatitis including those with Inadequate Response to Dupilumab and/or Baricitinib: Results from the BioDay Registry.

机构信息

Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, The Netherlands.

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

Acta Derm Venereol. 2023 Feb 16;103:adv00872. doi: 10.2340/actadv.v103.5243.

Abstract

Clinical trials showed that upadacitinib, a selective Janus kinase-1 inhibitor, is effective for treatment of moderate-to-severe atopic dermatitis. However, daily practice studies are limited. This multicentre prospective study evaluated the effectiveness of 16 weeks of upadacitinib treatment for moderate-to-severe atopic dermatitis in adult patients, including those with previous inadequate response to dupilumab and/or baricitinib, in daily practice. A total of 47 patients from the Dutch BioDay registry treated with upadacitinib were included. Patients were evaluated at baseline, and after 4, 8 and 16 weeks of treatment. Effectiveness was assessed by clinician- and patient-reported outcome measurements. Safety was assessed by adverse events and laboratory assessments. Overall, the probabilities (95% confidence intervals) of achieving Eczema Area and Severity Index ≤ 7 and Numerical Rating Scale - pruritus ≤ 4 were 73.0% (53.7-86.3) and 69.4% (48.7-84.4), respectively. The effectiveness of upadacitinib was comparable in patients with inadequate response to dupilumab and/or baricitinib and in patients who were naïve for these treatments or who had stopped such treatments due to adverse events. Fourteen (29.8%) patients discontinued upadacitinib due to ineffectiveness, adverse events or both (8.5%, 14.9% and 6.4%, respectively). Most frequently reported adverse events were acneiform eruptions (n = 10, 21.3%), herpes simplex (n = 6, 12.8%), nausea and airway infections (both n = 4, 8.5%). In conclusion, upadacitinib is an effective treatment for patients with moderate-to-severe atopic dermatitis, including those with previous inadequate response to dupilumab and/or baricitinib treatment.

摘要

临床试验表明,选择性 Janus 激酶-1 抑制剂乌帕替尼(upadacitinib)对治疗中重度特应性皮炎有效。然而,每日实践研究有限。这项多中心前瞻性研究评估了乌帕替尼治疗成人中重度特应性皮炎的有效性,包括那些对度普利尤单抗和/或巴瑞替尼治疗反应不足的患者,这在日常实践中。共纳入来自荷兰 BioDay 登记处的 47 名接受乌帕替尼治疗的患者。患者在基线时、治疗 4、8 和 16 周时接受评估。有效性通过临床医生和患者报告的结局测量进行评估。安全性通过不良事件和实验室评估进行评估。总体而言,达到 Eczema Area and Severity Index≤7 和 Numerical Rating Scale-瘙痒≤4 的概率(95%置信区间)分别为 73.0%(53.7-86.3)和 69.4%(48.7-84.4)。乌帕替尼在对度普利尤单抗和/或巴瑞替尼治疗反应不足的患者中和在这些治疗药物-naïve 的患者以及因不良事件而停止这些治疗药物的患者中的有效性相当。由于疗效不佳、不良事件或两者兼有,14 名(29.8%)患者停用乌帕替尼,分别为 8.5%、14.9%和 6.4%。最常报告的不良事件是痤疮样皮疹(n=10,21.3%)、单纯疱疹(n=6,12.8%)、恶心和呼吸道感染(均 n=4,8.5%)。总之,乌帕替尼是治疗中重度特应性皮炎的有效药物,包括那些对度普利尤单抗和/或巴瑞替尼治疗反应不足的患者。

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