Yuqian Wang, Sheng Li, Juan Bai, Xiaoxuan Cai, Shunli Tang, Peiyi Lin, Qingmiao Sun, Jianjun Qiao, Hong Fang
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Only double-blind, randomized, active comparator, or placebo-controlled trials of bimekizumab treatment on patients with psoriasis were included in this study.</p><p><strong>Results: </strong>Five studies were identified, which included 2473 patients with moderate-to-severe plaque psoriasis. The results indicated that bimekizumab had better efficacy than placebo or active comparator for Psoriasis Area and Severity Index (PASI) 90 [risk ratio (RR) = 29.29, 1.52; 95% confidence interval (CI) = 10.30-83.30, 1.06-2.19], PASI 100 (RR = 59.87, 2.06; 95% CI = 15.06-237.99, 1.12-3.79), and Investigator's Global Assessment scores of 0 or 1 (IGA 0/1) (RR = 21.55, 1.36; 95% CI = 9.25-50.19, 1.02-1.81). Faster onset of clinically meaningful responses was observed with bimekizumab compared with both active comparators (RR = 2.59; 95% CI = 1.32-5.10) and placebo (RR = 40.46; 95% CI = 13.19-124.13), with PASI 75 response observed at week 4 after one dose. Subgroup analysis showed no significant difference in the reduction of PASI scores between 320 mg q4w dosage and q8w dosage (RR = 1.00; 95% CI = 0.96-1.03). Rates of patients with adverse events (AEs) were comparable in the bimekizumab and active comparator groups (RR = 1.13; 95% CI = 1.01-1.26), and oral candidiasis was one of the most common treatment-emergent AEs.</p><p><strong>Conclusion: </strong>The results of this meta-analysis suggest that bimekizumab is more efficacious and has a rapid onset of action than active comparators and placebo in the treatment of moderate-to-severe plaque psoriasis. After 16 weeks of initial maintenance treatment, both bimekizumab maintenance dosing schedules (320 mg every 4 and 8 weeks) had similar efficacy.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"14 ","pages":"20406223231163110"},"PeriodicalIF":3.3000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3e/1d/10.1177_20406223231163110.PMC10084576.pdf","citationCount":"1","resultStr":"{\"title\":\"Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: a meta-analysis of randomized clinical trials.\",\"authors\":\"Yuqian Wang, Sheng Li, Juan Bai, Xiaoxuan Cai, Shunli Tang, Peiyi Lin, Qingmiao Sun, Jianjun Qiao, Hong Fang\",\"doi\":\"10.1177/20406223231163110\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, and is a promising drug for patients with moderate-to-severe plaque psoriasis.</p><p><strong>Objectives: </strong>This study aimed to assess the efficacy and safety of bimekizumab in treating patients with psoriasis and to determine the optimal maintenance dosing schedules of bimekizumab.</p><p><strong>Methods and design: </strong>Eligible trials were identified from PubMed, Cochrane Controlled Register of Trials, Embase, ClinicalTrials.gov, and Chinese medical databases. Only double-blind, randomized, active comparator, or placebo-controlled trials of bimekizumab treatment on patients with psoriasis were included in this study.</p><p><strong>Results: </strong>Five studies were identified, which included 2473 patients with moderate-to-severe plaque psoriasis. The results indicated that bimekizumab had better efficacy than placebo or active comparator for Psoriasis Area and Severity Index (PASI) 90 [risk ratio (RR) = 29.29, 1.52; 95% confidence interval (CI) = 10.30-83.30, 1.06-2.19], PASI 100 (RR = 59.87, 2.06; 95% CI = 15.06-237.99, 1.12-3.79), and Investigator's Global Assessment scores of 0 or 1 (IGA 0/1) (RR = 21.55, 1.36; 95% CI = 9.25-50.19, 1.02-1.81). Faster onset of clinically meaningful responses was observed with bimekizumab compared with both active comparators (RR = 2.59; 95% CI = 1.32-5.10) and placebo (RR = 40.46; 95% CI = 13.19-124.13), with PASI 75 response observed at week 4 after one dose. 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引用次数: 1
摘要
背景:Bimekizumab是一种单克隆IgG1抗体,可选择性抑制白细胞介素(IL)-17A和IL- 17f,是一种治疗中重度斑块型银屑病的有希望的药物。目的:本研究旨在评估比美珠单抗治疗银屑病患者的有效性和安全性,并确定比美珠单抗的最佳维持给药方案。方法和设计:从PubMed、Cochrane对照试验登记册、Embase、ClinicalTrials.gov和中国医学数据库中确定符合条件的试验。本研究仅包括双盲、随机、主动比较或安慰剂对照的比美珠单抗治疗银屑病患者的试验。结果:纳入5项研究,共纳入2473例中重度斑块型银屑病患者。结果显示,比美珠单抗治疗银屑病面积及严重程度指数(PASI) 90的疗效优于安慰剂或活性比较物[风险比(RR) = 29.29, 1.52;95%可信区间(CI) = 10.30-83.30, 1.06-2.19], PASI 100 (RR = 59.87, 2.06;95% CI = 15.06-237.99, 1.12-3.79),研究者整体评估评分为0或1 (IGA 0/1) (RR = 21.55, 1.36;95% ci = 9.25-50.19, 1.02-1.81)。比美珠单抗与两种活性对照药相比,更快地出现有临床意义的反应(RR = 2.59;95% CI = 1.32-5.10)和安慰剂(RR = 40.46;95% CI = 13.19-124.13),在一次剂量后第4周观察到PASI 75反应。亚组分析显示,320 mg q4w剂量组与q8w剂量组PASI评分降低差异无统计学意义(RR = 1.00;95% ci = 0.96-1.03)。比美珠单抗组和活性比较组的不良事件发生率(ae)相当(RR = 1.13;95% CI = 1.01-1.26),口腔念珠菌病是最常见的治疗突发事件之一。结论:本荟萃分析的结果表明,在治疗中重度斑块性银屑病方面,比活性比较物和安慰剂更有效,起效更快。在16周的初始维持治疗后,两种比美珠单抗维持剂量计划(每4周和8周320 mg)具有相似的疗效。
Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: a meta-analysis of randomized clinical trials.
Background: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, and is a promising drug for patients with moderate-to-severe plaque psoriasis.
Objectives: This study aimed to assess the efficacy and safety of bimekizumab in treating patients with psoriasis and to determine the optimal maintenance dosing schedules of bimekizumab.
Methods and design: Eligible trials were identified from PubMed, Cochrane Controlled Register of Trials, Embase, ClinicalTrials.gov, and Chinese medical databases. Only double-blind, randomized, active comparator, or placebo-controlled trials of bimekizumab treatment on patients with psoriasis were included in this study.
Results: Five studies were identified, which included 2473 patients with moderate-to-severe plaque psoriasis. The results indicated that bimekizumab had better efficacy than placebo or active comparator for Psoriasis Area and Severity Index (PASI) 90 [risk ratio (RR) = 29.29, 1.52; 95% confidence interval (CI) = 10.30-83.30, 1.06-2.19], PASI 100 (RR = 59.87, 2.06; 95% CI = 15.06-237.99, 1.12-3.79), and Investigator's Global Assessment scores of 0 or 1 (IGA 0/1) (RR = 21.55, 1.36; 95% CI = 9.25-50.19, 1.02-1.81). Faster onset of clinically meaningful responses was observed with bimekizumab compared with both active comparators (RR = 2.59; 95% CI = 1.32-5.10) and placebo (RR = 40.46; 95% CI = 13.19-124.13), with PASI 75 response observed at week 4 after one dose. Subgroup analysis showed no significant difference in the reduction of PASI scores between 320 mg q4w dosage and q8w dosage (RR = 1.00; 95% CI = 0.96-1.03). Rates of patients with adverse events (AEs) were comparable in the bimekizumab and active comparator groups (RR = 1.13; 95% CI = 1.01-1.26), and oral candidiasis was one of the most common treatment-emergent AEs.
Conclusion: The results of this meta-analysis suggest that bimekizumab is more efficacious and has a rapid onset of action than active comparators and placebo in the treatment of moderate-to-severe plaque psoriasis. After 16 weeks of initial maintenance treatment, both bimekizumab maintenance dosing schedules (320 mg every 4 and 8 weeks) had similar efficacy.
期刊介绍:
Therapeutic Advances in Chronic Disease publishes the highest quality peer-reviewed research, reviews and scholarly comment in the drug treatment of all chronic diseases. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers involved in the medical treatment of chronic disease, providing a forum in print and online for publishing the highest quality articles in this area.