Andrew Blauvelt, Kilian Eyerich, Alan D Irvine, Marjolein de Bruin-Weller, Shawn G Kwatra, Melinda Gooderham, Brian Kim, Brian M Calimlim, Wan-Ju Lee, Eliza M Raymundo, Yingyi Liu, Sarah Ofori, Andrew M Platt, Jonathan I Silverberg
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Measure Up 1 and 2 were replicate, randomized, double-blind, placebo-controlled phase 3 studies with patients randomized (1:1:1) to once-daily oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo for 16 weeks. Heads Up was a head-to-head, randomized, double-blind, double-dummy, phase 3b study with patients randomized (1:1) to upadacitinib 30 mg or subcutaneous dupilumab 300 mg for 24 weeks. Skin clearance was assessed with the Eczema Area and Severity Index (EASI) at baseline, weeks 1, 2, and 4, and every 4 weeks thereafter. Itch was assessed using the Worst Pruritus Numerical Rating Scale (WP-NRS) daily over 16 weeks and every 2 weeks thereafter to week 24 in Heads Up.</p><p><strong>Results: </strong>This analysis included 1683 patients in Measure Up 1 and 2 and 673 patients in Heads Up. 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引用次数: 0
摘要
简介：特应性皮炎（AD）的主要症状是瘙痒和皮损，常常影响患者的生活质量。我们评估了中度至重度特应性皮炎患者在达达替尼治疗与安慰剂或杜比鲁单抗治疗期间皮肤无瘙痒/几乎无瘙痒和无瘙痒/轻微瘙痒的时间：该分析包括对Measure Up 1 (NCT03569293)、Measure Up 2 (NCT03607422)和Heads Up (NCT03738397)的事后分析。Measure Up 1 和 2 是重复、随机、双盲、安慰剂对照的 3 期研究，患者被随机（1:1:1）分配到每日口服一次的达达替尼 15 毫克、达达替尼 30 毫克或安慰剂，为期 16 周。Heads Up是一项头对头、随机、双盲、双哑药的3b期研究，患者随机（1:1:1）接受达帕替尼30毫克或皮下注射dupilumab 300毫克，为期24周。在基线、第1周、第2周和第4周，以及此后每4周，用湿疹面积和严重程度指数（EASI）评估皮肤清除率。在16周内每天使用最严重瘙痒数字评定量表（WP-NRS）评估瘙痒情况，此后每2周评估一次，直至Heads Up第24周：这项分析包括参加 Measure Up 1 和 2 的 1683 名患者以及参加 Heads Up 的 673 名患者。与安慰剂相比，在Measure Up 1和2的16周中，接受达达替尼治疗的患者EASI 90应答天数是安慰剂的9.8-13.4倍，WP-NRS 0/1应答天数是安慰剂的7.0-10.3倍。在 "Heads Up "研究中，接受达帕替尼治疗的患者在16周和24周内出现EASI 90反应的天数分别是接受达帕替尼治疗的患者的2.0倍和1.7倍。在16周和24周内，接受达达替尼治疗的患者与杜比鲁单抗相比，WP-NRS 0/1反应的天数分别是后者的3.0倍和2.6倍：结论：与安慰剂或杜比鲁单抗相比，中重度AD患者接受达帕替尼治疗后皮肤透明/几乎透明、无痒/微痒的时间更长：试验注册：ClinicalTrials.gov标识符，Measure Up 1 (NCT03569293)，Measure Up 2 (NCT03607422)，Heads Up (NCT03738397)。
More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis.
Introduction: Atopic dermatitis (AD), with its hallmark symptoms of pruritus and skin lesions, often impairs patients' quality of life. We assessed time spent with clear/almost clear skin and no/minimal itch during upadacitinib treatment versus placebo or dupilumab among patients with moderate-to-severe AD.
Methods: This analysis consisted of a post hoc analysis of Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), and Heads Up (NCT03738397). Measure Up 1 and 2 were replicate, randomized, double-blind, placebo-controlled phase 3 studies with patients randomized (1:1:1) to once-daily oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo for 16 weeks. Heads Up was a head-to-head, randomized, double-blind, double-dummy, phase 3b study with patients randomized (1:1) to upadacitinib 30 mg or subcutaneous dupilumab 300 mg for 24 weeks. Skin clearance was assessed with the Eczema Area and Severity Index (EASI) at baseline, weeks 1, 2, and 4, and every 4 weeks thereafter. Itch was assessed using the Worst Pruritus Numerical Rating Scale (WP-NRS) daily over 16 weeks and every 2 weeks thereafter to week 24 in Heads Up.
Results: This analysis included 1683 patients in Measure Up 1 and 2 and 673 patients in Heads Up. Through 16 weeks in Measure Up 1 and 2, patients receiving upadacitinib spent 9.8-13.4 times as many days with an EASI 90 response and 7.0-10.3 times as many days with a WP-NRS 0/1 response versus placebo. In Heads Up, patients receiving upadacitinib spent 2.0 and 1.7 times as many days through 16 and 24 weeks, respectively, with an EASI 90 response versus dupilumab. Through 16 and 24 weeks, patients receiving upadacitinib spent 3.0 and 2.6 times as many days, respectively, with a WP-NRS 0/1 response versus dupilumab.
Conclusions: Patients with moderate-to-severe AD spent more time with clear/almost clear skin and no/minimal itch with upadacitinib versus placebo or dupilumab.
Trial registration: ClinicalTrials.gov identifier, Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), Heads Up (NCT03738397).
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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