Safety of Bimekizumab for Plaque Psoriasis: An Expert Consensus Panel.

IF 1.5 4区 医学 Q3 DERMATOLOGY Journal of Drugs in Dermatology Pub Date : 2024-08-01 DOI:10.36849/JDD.8246
Joshua Burshtein, Milaan Shah, Danny Zakria, April W Armstrong, Alexandra K Golant, Alice B Gottlieb, Jeffrey M Weinberg, Leon Kircik, George Han, Richard G Langley, Andrea L Neimann, Mark Lebwohl
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Abstract

Background: Plaque psoriasis is a chronic, relapsing systemic illness that has a significant effect on quality of life. Bimekizumab is the first monoclonal antibody to target both interleukin (IL)-17A and IL-17F, and recently received Food and Drug Administration (FDA) approval for moderate to severe plaque psoriasis. Guidance is necessary regarding the safety of bimekizumab.

Methods: A comprehensive literature search of PubMed, Scopus, and Google Scholar was completed for English-language original research articles on the safety of bimekizumab for moderate to severe psoriasis. A panel of 9 dermatologists and 1 rheumatologist with significant expertise in the treatment of psoriasis gathered to review the articles and create consensus statements on this new medication. A modified Delphi process was used to approve each statement, and strength of recommendation was assigned using the Strength of Recommendation Taxonomy criteria.

Results: The literature search produced 110 articles that met the criteria. A thorough screening of the studies for relevance to the research question resulted in 15 articles. These were distributed to all panelists for review prior to a roundtable discussion. The panel unanimously voted to adopt 5 consensus statements and recommendations, all of which were given a strength of "A".

Conclusion: Bimekizumab has a safety profile consistent with other biologics, except for a higher risk of oral candidiasis. Its hepatic safety profile is comparable with other currently FDA-approved biologics for plaque psoriasis. In addition, the data do not support an association of bimekizumab with suicide, and the incidence of inflammatory bowel disease is not greater than the incidence of other IL-17 blockers. J Drugs Dermatol. 2024;23(8):592-599. doi:10.36849/JDD.8246.

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Bimekizumab 治疗斑块状银屑病的安全性:专家共识小组。
背景:斑块状银屑病是一种慢性、复发性全身性疾病,严重影响患者的生活质量。比美单抗是首个同时针对白细胞介素(IL)-17A和IL-17F的单克隆抗体,最近获得了美国食品药品管理局(FDA)的批准,用于治疗中度至重度斑块状银屑病。有必要就bimekizumab的安全性提供指导:在PubMed、Scopus和Google Scholar上对有关bimekizumab治疗中重度银屑病安全性的英文原创研究文章进行了全面的文献检索。由 9 位皮肤科医生和 1 位风湿病医生组成的专家小组在治疗银屑病方面具有丰富的专业知识,他们对文章进行了审阅,并就这种新药达成了共识。每份声明均采用修改后的德尔菲流程进行审批,并根据推荐强度分类标准确定推荐强度:文献检索结果有 110 篇文章符合标准。在对这些研究与研究问题的相关性进行彻底筛选后,共筛选出 15 篇文章。在圆桌讨论之前,这些文章已分发给所有小组成员审阅。专家小组一致投票通过了 5 项共识声明和建议,所有声明和建议的强度均为 "A":除口腔念珠菌病风险较高外,Bimekizumab 的安全性与其他生物制剂一致。其肝安全性与目前美国食品及药物管理局批准的其他治疗斑块状银屑病的生物制剂相当。此外,数据不支持 bimekizumab 与自杀有关,炎症性肠病的发病率也不高于其他 IL-17 阻断剂。J Drugs Dermatol.2024;23(8):592-599. doi:10.36849/JDD.8246.
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来源期刊
CiteScore
2.20
自引率
13.30%
发文量
289
审稿时长
3-6 weeks
期刊介绍: The Journal of Drugs in Dermatology (JDD) is a peer-reviewed publication indexed with MEDLINE®/PubMed® that was founded by the renowned Dr. Perry Robins MD. Founded in 2002, it offers one of the fastest routes to disseminate dermatologic information and is considered the fastest growing publication in dermatology. We present original articles, award-winning case reports, and timely features pertaining to new methods, techniques, drug therapy, and devices in dermatology that provide readers with peer reviewed content of the utmost quality. Our high standards of content are maintained through a balanced, peer-review process. Articles are reviewed by an International Editorial Board of over 160 renowned experts.
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