Real-World Efficacy and Safety of Abrocitinib in Chinese Atopic Dermatitis Patients: A Single-Center Prospective Study

IF 12 1区医学 Q1 ALLERGY Allergy Pub Date : 2025-02-10 DOI:10.1111/all.16495

Zheng Li, Yu Wang, Yuemeng Wu, Huibin Yin, Shangshang Wang, Hao Wu, Haihong Qin, Ce Wang, Xu Yao, Wei Li, Chaoying Gu

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Abstract

Background

Phase 3 trials have demonstrated the efficacy and safety of abrocitinib for atopic dermatitis (AD), but real-world evidence remains limited.

Methods

This study prospectively enrolled 117 moderate-to-severe AD patients at Huashan Hospital, Shanghai, China. Physician- and patient-reported outcomes were evaluated at multiple time points. Blood eosinophil counts, serum IgE, and 24 cytokines/chemokines were measured.

Results

Abrocitinib treatment led to rapid and potent improvements in disease severity. At week 12, 74.3% and 50.5% of AD patients achieved at least 75% and 90% improvement in the eczema area and severity index (EASI), respectively. Compared to dupilumab, abrocitinib showed greater improvement in Itch-NRS at week 2 and a higher proportion of EASI-75 at week 4. Adverse events occurred in 42.7% of AD patients, with gastrointestinal symptoms being the most common (17.1%). No tuberculosis (TB) reactivation was observed in patients who screened positive for TB and received isoniazid prophylaxis during the study period. Lower body mass index (BMI < 24; adjusted OR: 4.01, 95% CI: 1.36–11.73) and no prior dupilumab use (adjusted OR: 5.81, 95% CI: 1.8–18.7) were identified as predictors of a good response. By week 4, blood eosinophil counts and serum IgE significantly decreased. Reductions in Th2-, Th1-, and Treg-related cytokines/chemokines after 4 weeks of abrocitinib treatment, including IL-5, CCL17, CCL18, TNF-α, IL-6, IL-10, and CD25/IL-2Rα, were more pronounced in good responders.

Conclusion

Abrocitinib demonstrated robust efficacy and a well-tolerated safety profile in Chinese patients with moderate-to-severe AD in routine clinical practice, accompanied by normalization of elevated blood biomarkers.

Trial Registration

ChiCRT Identifier: ChiCTR2200063195

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阿布替尼治疗中国特应性皮炎患者的实际疗效和安全性：一项单中心前瞻性研究。

背景：3期临床试验已经证明了abrocitinib治疗特应性皮炎（AD）的有效性和安全性，但实际证据仍然有限。方法：本研究前瞻性纳入中国上海华山医院117例中重度AD患者。医生和患者报告的结果在多个时间点进行评估。测定血嗜酸性粒细胞计数、血清IgE和24种细胞因子/趋化因子。结果：阿布替尼治疗导致疾病严重程度的快速和有效改善。在第12周，74.3%和50.5%的AD患者分别在湿疹面积和严重程度指数（EASI）方面达到至少75%和90%的改善。与dupilumab相比，abrocitinib在第2周对瘙痒- nrs的改善更大，在第4周时EASI-75的比例更高。42.7%的AD患者发生不良事件，其中胃肠道症状最为常见（17.1%）。在研究期间，结核病筛查阳性并接受异烟肼预防治疗的患者未观察到结核病（TB）再激活。结论：在常规临床实践中，Abrocitinib在中国中重度AD患者中表现出强大的疗效和良好的耐受性安全性，并伴有血液生物标志物升高的正常化。试验注册：ChiCRT标识符：ChiCTR2200063195。

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来源期刊

Allergy 医学-过敏

CiteScore

26.10

自引率

9.70%

发文量

393

审稿时长

2 months

期刊介绍： Allergy is an international and multidisciplinary journal that aims to advance, impact, and communicate all aspects of the discipline of Allergy/Immunology. It publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors, and correspondences. The journal accepts articles based on their scientific merit and quality. Allergy seeks to maintain contact between basic and clinical Allergy/Immunology and encourages contributions from contributors and readers from all countries. In addition to its publication, Allergy also provides abstracting and indexing information. Some of the databases that include Allergy abstracts are Abstracts on Hygiene & Communicable Disease, Academic Search Alumni Edition, AgBiotech News & Information, AGRICOLA Database, Biological Abstracts, PubMed Dietary Supplement Subset, and Global Health, among others.