Margaret E Greer, Shannon K Moran, Steven R Feldman
{"title":"用于治疗斑块状银屑病的 Bimekizumab-bkzx:药物综述。","authors":"Margaret E Greer, Shannon K Moran, Steven R Feldman","doi":"10.1177/10600280241288553","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Data sources: </strong>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.</p><p><strong>Study selection, data extraction: </strong>We summarized 1 phase I, 4 phase II, and 4 phase III trials, and 3 real-world studies published post-FDA approval.</p><p><strong>Data synthesis: </strong>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.</p><p><strong>Relevance to patient care and clinical practice in comparison to existing drugs: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241288553"},"PeriodicalIF":2.3000,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Bimekizumab-bkzx for the Treatment of Plaque Psoriasis: A Drug Review.\",\"authors\":\"Margaret E Greer, Shannon K Moran, Steven R Feldman\",\"doi\":\"10.1177/10600280241288553\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Data sources: </strong>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.</p><p><strong>Study selection, data extraction: </strong>We summarized 1 phase I, 4 phase II, and 4 phase III trials, and 3 real-world studies published post-FDA approval.</p><p><strong>Data synthesis: </strong>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.</p><p><strong>Relevance to patient care and clinical practice in comparison to existing drugs: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":7933,\"journal\":{\"name\":\"Annals of Pharmacotherapy\",\"volume\":\" \",\"pages\":\"10600280241288553\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-10-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Pharmacotherapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/10600280241288553\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Pharmacotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/10600280241288553","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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.
期刊介绍:
Annals of Pharmacotherapy (AOP) is a peer-reviewed journal that advances pharmacotherapy throughout the world by publishing high-quality research and review articles to achieve the most desired health outcomes.The articles provide cutting-edge information about the most efficient, safe and cost-effective pharmacotherapy for the treatment and prevention of various illnesses. This journal is a member of the Committee on Publication Ethics (COPE). Average time from submission to first decision: 14 days