用于治疗斑块状银屑病的 Bimekizumab-bkzx:药物综述。

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-10-19 DOI:10.1177/10600280241288553
Margaret E Greer, Shannon K Moran, Steven R Feldman
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引用次数: 0

摘要

背景:比美单抗是一种靶向白细胞介素(IL)-17A/17F的生物制剂,于2023年获得美国食品药品管理局(FDA)批准用于治疗中重度斑块状银屑病:使用关键词 "bimekizumab"、"斑块状银屑病 "和 "bimekizumab临床试验 "在PubMed上进行了搜索,搜索时间从开始到2024年8月1日。我们纳入了bimekizumab治疗斑块状银屑病的I期至III期试验、FDA批准后发表的研究以及包装说明书中的信息:我们总结了1项I期、4项II期和4项III期试验,以及3项FDA批准后发表的真实世界研究:比美单抗疗效显著;在 III 期试验中,分别有超过 85% 和 70% 的患者达到了 PASI90 和 PASI100。头对头试验中,85%的比美单抗患者达到了PASI90,而乌司替尼患者只有50%。最常见的不良事件是口腔念珠菌病(4%-10%);严重不良事件很少发生(与现有药物相比,与患者护理和临床实践的相关性:Bimekizumab的疗效优于其他IL-17抑制剂、乌斯特库单抗和阿达木单抗。真实世界的数据证实了比美单抗的疗效。Bimekizumab的安全性与其他IL-17抑制剂相似,但皮肤黏膜念珠菌病的发病率较高:结论:许多患者在使用其他IL-17抑制剂失败后改用bimekizumab,结果都获得了清除。bimekizumab对其他IL-17抑制剂无效患者的疗效可能归因于bimekizumab能够阻断多种IL-17同工酶。bimekizumab的疗效也优于肿瘤坏死因子(TNF)-α抑制剂。由于不依从性、抗药抗体或不良反应等原因,有些患者可能无法使用以前的药物;而针对其他细胞因子的bimekizumab可以弥补这一缺陷。
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Bimekizumab-bkzx for the Treatment of Plaque Psoriasis: A Drug Review.

Background: Bimekizumab is a biologic targeting interleukin (IL)-17A/17F, approved by the Food and Drug Administration (FDA) for moderate-to-severe plaque psoriasis in 2023.

Data sources: A PubMed search was performed using the keywords "bimekizumab," "plaque psoriasis," and "bimekizumab clinical trials," from origin to August 1, 2024. We included phase I to III trials of bimekizumab for plaque psoriasis, studies published post-FDA approval, and information from the package insert.

Study selection, data extraction: We summarized 1 phase I, 4 phase II, and 4 phase III trials, and 3 real-world studies published post-FDA approval.

Data synthesis: Bimekizumab was effective; >85% and 70% of patients achieved PASI90 and PASI100, respectively, in phase III trials. Head-to-head, 85% of bimekizumab patients achieved PASI90 versus 50% of ustekinumab patients. The most frequent adverse event was oral candidiasis (4%-10%); serious adverse events were rare (<1%). Long-term studies confirmed sustained efficacy and consistent safety profile.

Relevance to patient care and clinical practice in comparison to existing drugs: Bimekizumab was more efficacious than other IL-17 inhibitors, ustekinumab, and adalimumab. Real-world data corroborate bimekizumab's efficacy. Bimekizumab had a safety profile like other IL-17 inhibitors, with higher rates of mucocutaneous candidiasis.

Conclusion: Many patients who failed other IL-17 inhibitors and switched to bimekizumab experienced clearance. The efficacy of bimekizumab in patients who failed other IL-17 blockers may be attributable to bimekizumab's ability to block multiple IL-17 isoforms. Bimekizumab also outperformed tumor necrosis factor (TNF)-alpha inhibitors. There may be patients who fail previously available drugs, for reasons including nonadherence, antidrug antibodies, or adverse effects; bimekizumab, which targets additional cytokines, may bridge that gap.

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ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
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9.40
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2.10%
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464
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