Meta-analysis and GRADE assessment of randomized controlled trials on the efficacy and safety of bimekizumab in psoriatic arthritis patients

A persistent immune-mediated inflammatory disorder called psoriatic arthritis affects about 25% of persons with psoriasis. Bimekizumab, a humanized monoclonal IgG1 antibody, is a novel therapeutic approach that inhibits homodimers and heterodimers of IL-17A and IL-17F by binding to comparable locations in these molecules. Bimekizumab was the subject of a meta-analysis to assess its efficacy and safety in psoriatic arthritis patients. All randomized clinical trials were looked up on PubMed, Scopus, and Web of Science. The Systematic Review Accelerator tool was used to screen them, and RevMan was used to analyze them. The Mean Difference (MD) and 95% Confidence Interval (CI) were used to examine continuous data, whereas the Risk Ratio (RR) and 95% CI were used to evaluate dichotomous data. A total of 1364 participants from 4 trials were included in this meta-analysis. The number of participants who met the American College of Rheumatology 50 threshold was significantly higher in the bimekizumab group compared to the placebo group [RR = 4.94, 95% CI (3.73, 6.55), <i>p</i> &lt; .00001]. Psoriasis Area and Severity Index 100 was achieved by significantly more people in the bimekizumab group than in the placebo group [RR = 11.45, 95% CI (6.67, 19.67), <i>p</i> &lt; .00001]. There was no significant difference between the bimekizumab group and the placebo group in terms of treatment-emergent adverse events [RR = 1.08, 95% CI (0.97, 1.21), <i>p</i> = .15]. In comparison to a placebo, bimekizumab treatment significantly improved joint and skin efficacy outcomes. Also, its safety results were acceptable.

约25%的银屑病（psoriasis）患者会罹患一种名为银屑病关节炎（psoriatic arthritis）的持续性免疫介导性炎症性疾病。比美吉珠单抗（Bimekizumab）是一种人源化IgG1单克隆抗体，属于新型治疗手段，可通过结合白细胞介素17A（IL-17A）与白细胞介素17F（IL-17F）的同源二聚体及异源二聚体的相似结合位点，对二者发挥抑制作用。本荟萃分析旨在评估比美吉珠单抗用于银屑病关节炎患者的疗效与安全性。研究人员在PubMed、Scopus及Web of Science数据库中检索了所有随机对照试验，采用系统评价加速器工具进行文献筛选，并使用RevMan软件开展数据分析。对于连续性数据，采用均数差（Mean Difference，MD）与95%置信区间（95% Confidence Interval，CI）进行分析；对于二分类数据，则采用风险比（Risk Ratio，RR）与95%置信区间进行评估。本次荟萃分析最终纳入4项试验的1364名受试者。相较于安慰剂组，比美吉珠单抗组达到美国风湿病学会50%应答标准（American College of Rheumatology 50）的受试者人数显著更高[RR = 4.94, 95% CI (3.73, 6.55), *p* < 0.00001]。比美吉珠单抗组达到银屑病面积与严重性指数100（Psoriasis Area and Severity Index 100）的受试者人数同样显著多于安慰剂组[RR = 11.45, 95% CI (6.67, 19.67), *p* < 0.00001]。两组的治疗突发不良事件发生率无显著差异[RR = 1.08, 95% CI (0.97, 1.21), *p* = 0.15]。相较于安慰剂，比美吉珠单抗治疗可显著改善关节与皮肤相关疗效结局，且安全性表现良好。