J Drugs Dermatol. 2024 Aug 1;23(8):592-599. doi: 10.36849/JDD.8246.
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.
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.
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".
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.
斑块状银屑病是一种慢性、复发性全身性疾病，对生活质量有重大影响。Bimekizumab 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监督管理局 (FDA) 对中重度斑块状银屑病的批准。有必要对 bimekizumab 的安全性进行指导。
对 PubMed、Scopus 和 Google Scholar 进行了全面的文献检索，以获取有关 bimekizumab 治疗中度至重度银屑病安全性的英文原始研究文章。一个由 9 名皮肤科医生和 1 名风湿病专家组成的小组，他们在治疗银屑病方面具有丰富的专业知识，聚集在一起审查这些文章，并就这种新药物达成共识声明。采用改良 Delphi 流程对每个声明进行批准，并使用推荐强度分类标准分配推荐强度。
文献搜索产生了 110 篇符合标准的文章。对与研究问题相关的研究进行了彻底筛选，结果有 15 篇文章符合要求。这些文章分发给所有小组成员进行审查，然后进行小组讨论。小组一致投票通过了 5 项共识声明和建议，所有这些都被给予“强烈推荐”的强度。
bimekizumab 的安全性与其他生物制剂一致，但口腔念珠菌病的风险较高。其肝脏安全性与其他目前获得 FDA 批准用于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并不高于其他 IL-17 阻滞剂。J 皮肤病药物杂志。2024;23(8):592-599. doi:10.36849/JDD.8246.
