Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis?

IF 4.2 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-09-23 DOI:10.1007/s13555-025-01516-w

Eric L Simpson, Jonathan I Silverberg, Bob Geng, José-Manuel Carrascosa, Thomas Bieber, Patrick M Brunner, Delphine Staumont-Sallé, Chao Ji, Pinaki Biswas, Claire Feeney, Irene Hernández-Martín, Francisco José Rebollo Laserna, Herwig Koppensteiner

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Abstract

Introduction: Allergic comorbidities are common in patients with atopic dermatitis (AD). Individual trials with abrocitinib or dupilumab demonstrated efficacy and safety in patients with moderate-to-severe AD and allergic comorbidities. This post hoc analysis of the phase 3 JADE COMPARE and DARE trials compared efficacy, safety, and quality of life following abrocitinib and dupilumab treatment in adults with moderate-to-severe AD, with or without comorbid asthma, allergic rhinitis, or food allergy.

Methods: Data were pooled from patients who received abrocitinib (200 mg/day) or dupilumab (300 mg/every 2 weeks) for 16 weeks with concomitant topical therapy. Assessments by self-reported asthma, allergic rhinitis, or food allergy included the proportion of patients achieving Investigator's Global Assessment of clear or almost clear (IGA 0/1), ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4), least squares mean change from baseline in Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis (SCORAD), and safety.

Results: Of 1195 patients (abrocitinib, n = 588; dupilumab, n = 607), 377 (32%), 225 (19%), and 211 (18%) patients self-reported comorbid asthma, food allergy, or allergic rhinitis, respectively. Week 16 IGA 0/1 responses were comparable between patients with/without comorbidity with abrocitinib (52%/54% [with/without asthma], 50%/54% [with/without allergic rhinitis], and 53%/53% [with/without food allergy]) or dupilumab (42%/42%, 37%/43%, and 47%/41%). EASI-75 and PP-NRS4 responses and DLQI and SCORAD improvements were also comparable between patients with/without comorbidity in each treatment arm. Treatment-emergent adverse events were more common in patients with comorbidities in the abrocitinib (76%/67% [with/without asthma], 80%/67% [with/without allergic rhinitis], and 78%/67% [with/without food allergy]) and dupilumab (71%/53%, 71%/57%, and 62%/59%) arms.

Conclusion: Abrocitinib and dupilumab improved AD signs and symptoms with a manageable safety profile in patients with moderate-to-severe AD, regardless of asthma, allergic rhinitis, or food allergy. Graphical Abstract available for this article.

Trial registration: ClinicalTrials.gov identifier, NCT03720470 (JADE COMPARE) and NCT04345367 (DARE).

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过敏性合并症会改变阿布替尼或杜匹单抗治疗中重度特应性皮炎的疗效和安全性吗？

过敏性合并症在特应性皮炎（AD）患者中很常见。阿布替尼或杜匹单抗的个体试验证明了对中度至重度AD和过敏性合并症患者的有效性和安全性。这项对JADE COMPARE和DARE三期试验的事后分析比较了阿布替尼和杜匹单抗治疗中重度AD成人患者的疗效、安全性和生活质量，伴有或不伴有哮喘、过敏性鼻炎或食物过敏。方法：数据来自接受阿布替尼（200 mg/天）或杜匹单抗（300 mg/每2周）治疗16周的患者，并伴有局部治疗。通过自我报告的哮喘、过敏性鼻炎或食物过敏进行的评估包括达到研究者总体评估明确或几乎明确（IGA 0/1）、湿疹面积和严重程度指数（EASI-75）改善≥75%、峰值瘙痒数值评定量表（PP-NRS4）改善≥4分、皮肤病生活质量指数（DLQI）和特应性皮炎评分（SCORAD）基线的最小二乘平均变化以及安全性的患者比例。结果：1195例患者（阿布替尼，n = 588；杜匹单抗，n = 607）中，分别有377例（32%）、225例（19%）和211例（18%）患者自我报告患有哮喘、食物过敏或变应性鼻炎。第16周，伴有/不伴有阿布替尼合并症的患者（52%/54%[伴有/不伴有哮喘]，50%/54%[伴有/不伴有过敏性鼻炎]，53%/53%[伴有/不伴有食物过敏]）或杜匹单抗（42%/42%，37%/43%和47%/41%）之间的IGA 0/1反应具有可比性。EASI-75和PP-NRS4反应以及DLQI和SCORAD改善在每个治疗组中有无合并症的患者之间也具有可比性。阿布替尼组（76%/67%[伴有/不伴有哮喘]，80%/67%[伴有/不伴有过敏性鼻炎]，78%/67%[伴有/不伴有食物过敏]）和杜匹单抗组（71%/53%，71%/57%和62%/59%）合并症患者中治疗后出现的不良事件更为常见。结论：无论哮喘、变应性鼻炎或食物过敏，Abrocitinib和dupilumab均可改善中度至重度AD患者的AD体征和症状，且安全性可控制。本文提供的图形摘要。试验注册：ClinicalTrials.gov识别码，NCT03720470 （JADE COMPARE）和NCT04345367 （DARE）。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

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.