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病例报告:奥马珠单抗相关脱发:1例斑秃性眉毛脱落病例、文献综述及FAERS数据库分析

Case Report: Omalizumab-associated hair loss: a case of eyebrow alopecia areata, literature review and FAERS database analysis.

作者信息

Wang Qian, Lei Hua, Yang Ge, Li Ying, Liu Wei, Zhang Lixia, Zhou Xiyuan

机构信息

Institute of Dermatology and Venereology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology, Chengdu, China.

出版信息

Front Med (Lausanne). 2025 Jun 27;12:1605826. doi: 10.3389/fmed.2025.1605826. eCollection 2025.

DOI:10.3389/fmed.2025.1605826
PMID:40655099
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12245789/
Abstract

Hair loss is a rare adverse reaction associated with omalizumab, with limited literature reports. The incidence, underlying mechanisms, and clinical characteristics of omalizumab-associated hair loss have not been clarified. We report a 52-year-old female with chronic spontaneous urticaria (CSU) who developed significant loss of eyebrows after 12 weeks of omalizumab treatment at 300 mg per 4 weeks. The diagnosis of alopecia areata (AA) was confirmed through dermoscopic examination and clinical manifestation. While maintaining omalizumab treatment for CSU, topical 0.03% tacrolimus ointment was initiated for treatment of AA. Regrowth of eyebrows was observed at 28 weeks of omalizumab treatment. We then performed a literature review, analyzing eight patients from five articles and one conference abstract, and concurrently analyzed data from 756 cases reported in the FDA adverse event reporting system (FAERS) database of patients developing alopecia after omalizumab use. Our findings suggest that omalizumab may induce alopecia, particularly among females and individuals aged 18-60 years. However, establishing a direct cause-effect relationship between alopecia and the drug remains challenging. AA may be the more uncommon type of omalizumab-associated hair loss, though it may be a transient phenomenon. Even if the incidence of this adverse effect is low, it warrants the clinician's attention. Improved recognition of omalizumab-associated hair loss can optimize pretreatment preparation and patient counseling.

摘要

脱发是与奥马珠单抗相关的一种罕见不良反应,文献报道有限。奥马珠单抗相关脱发的发生率、潜在机制及临床特征尚未明确。我们报告一名52岁慢性自发性荨麻疹(CSU)女性患者,每4周皮下注射300mg奥马珠单抗治疗12周后出现显著眉毛脱落。通过皮肤镜检查和临床表现确诊为斑秃(AA)。在继续使用奥马珠单抗治疗CSU的同时,开始外用0.03%他克莫司软膏治疗AA。奥马珠单抗治疗28周时观察到眉毛重新生长。我们随后进行了文献综述,分析了五篇文章和一篇会议摘要中的8例患者,并同时分析了美国食品药品监督管理局不良事件报告系统(FAERS)数据库中756例使用奥马珠单抗后发生脱发患者的数据。我们的研究结果表明,奥马珠单抗可能诱发脱发,尤其是在女性和18至60岁的个体中。然而,确定脱发与该药物之间的直接因果关系仍然具有挑战性。AA可能是奥马珠单抗相关脱发中较不常见的类型,尽管它可能是一种短暂现象。即使这种不良反应的发生率较低,也值得临床医生关注。提高对奥马珠单抗相关脱发的认识有助于优化治疗前准备和患者咨询。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/404c/12245789/bf4d322b4976/fmed-12-1605826-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/404c/12245789/bf4d322b4976/fmed-12-1605826-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/404c/12245789/bf4d322b4976/fmed-12-1605826-g001.jpg

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本文引用的文献

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A real-world pharmacovigilance study of omalizumab using disproportionality analysis in the FDA adverse drug events reporting system database.一项在FDA不良药物事件报告系统数据库中使用不成比例分析的奥马珠单抗真实世界药物警戒研究。
Sci Rep. 2025 Mar 7;15(1):8045. doi: 10.1038/s41598-025-91463-5.
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Drug-Induced Hair Loss: Analysis of the Food and Drug Administration's Adverse Events Reporting System Database.药物性脱发:对美国食品药品监督管理局不良事件报告系统数据库的分析
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Int J Dermatol. 2024 Apr;63(4):497-502. doi: 10.1111/ijd.17014. Epub 2024 Jan 12.
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A real-world pharmacovigilance study of mepolizumab in the FDA adverse event reporting system (FAERS) database.一项在FDA不良事件报告系统(FAERS)数据库中进行的美泊利单抗真实世界药物警戒研究。
Front Pharmacol. 2023 Dec 21;14:1320458. doi: 10.3389/fphar.2023.1320458. eCollection 2023.
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Omalizumab in the treatment of bullous pemphigoid resistant to first-line therapy: a French national multicentre retrospective study of 100 patients.奥马珠单抗治疗一线治疗抵抗性大疱性类天疱疮:一项法国全国多中心回顾性研究,纳入 100 例患者。
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A long-term course of alopecia areata during omalizumab treatment: a case report.奥马珠单抗治疗期间斑秃的长期病程:一例报告
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