109例患者使用比美吉珠单抗48周的真实世界经验以及早期超反应预测因素和不良事件风险的识别。
Real-World Experience of Bimekizumab in a Cohort of 109 Patients Over 48 Weeks and Identification of Predictive Factors for an Early Super Response and Risk of Adverse Events.
作者信息
Fratton Zeno, Bighetti Stefano, Bettolini Luca, Maione Vincenzo, Arisi Mariachiara, Buligan Cinzia, Stinco Giuseppe, Errichetti Enzo
机构信息
Department of Medicine, Institute of Dermatology, University of Udine, Udine, Friuli Venezia-Giulia, Italy.
Dermatology Department, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Lombardia, Italy.
出版信息
Psoriasis (Auckl). 2025 Apr 11;15:145-158. doi: 10.2147/PTT.S514249. eCollection 2025.
INTRODUCTION
Psoriasis is a chronic inflammatory skin disease significantly impairing quality of life. The introduction of biologic therapies, such as bimekizumab-a monoclonal antibody targeting IL-17A and IL-17F-has revolutionized treatment outcomes. This study investigates the effectiveness of bimekizumab in a real-world setting, focusing on the predictors of Early Super Response (ESR), defined as achieving PASI 100 by week 4, and evaluates the safety profile over a 48-week follow-up period.
METHODS
A retrospective study was conducted on 109 psoriasis patients treated with bimekizumab at two Italian dermatology centers. Of these, 61 patients completed a 48-weeks follow-up. Baseline clinical and demographic data, PASI scores at multiple time points, and adverse events were collected. ESR predictors were analyzed using univariate and multivariate logistic regression models. Safety was assessed using Cox proportional hazards models to find predictive factors associated with the risk of adverse events (AEs).
RESULTS
At week 4, 28.4% of patients achieved PASI 100. Baseline PASI (OR: 0.93, p = 0.029), absence of nail involvement (OR: 0.12, p = 0.003), and fewer biologic failures (OR: 0.14, p = 0.038) were independently associated with ESR status. Safety analysis revealed that 15.6% of patients experienced adverse events, with asthma/allergic rhinitis significantly associated with a higher risk (HR: 6.43, p = 0.012). Candidiasis (7.3%) and eczema (4.6%) were the most common adverse events.
CONCLUSION
Bimekizumab demonstrated significant effectiveness and an acceptable safety profile in a real-world setting. Baseline PASI, nail involvement, and prior biologic failures influenced early treatment response. Identifying predictors of ESR and adverse events can guide personalized therapeutic approaches, optimizing outcomes for psoriasis patients.
引言
银屑病是一种严重影响生活质量的慢性炎症性皮肤病。双特异性抗体疗法的引入,如比美吉珠单抗——一种靶向白细胞介素-17A和白细胞介素-17F的单克隆抗体——彻底改变了治疗效果。本研究调查了比美吉珠单抗在真实世界环境中的有效性,重点关注早期超反应(ESR)的预测因素,即第4周达到银屑病面积和严重程度指数(PASI)100,并评估48周随访期内的安全性。
方法
对意大利两个皮肤科中心接受比美吉珠单抗治疗的109例银屑病患者进行了一项回顾性研究。其中,61例患者完成了48周的随访。收集了基线临床和人口统计学数据、多个时间点的PASI评分以及不良事件。使用单变量和多变量逻辑回归模型分析ESR预测因素。使用Cox比例风险模型评估安全性,以找出与不良事件(AE)风险相关的预测因素。
结果
在第4周时,28.4%的患者达到PASI 100。基线PASI(比值比:0.93,p = 0.029)、无指甲受累(比值比:0.12,p = 0.003)以及较少的生物制剂治疗失败(比值比:0.14,p = 0.038)与ESR状态独立相关。安全性分析显示,15.6%的患者发生了不良事件,哮喘/过敏性鼻炎与较高风险显著相关(风险比:6.43,p = 0.012)。念珠菌病(7.3%)和湿疹(4.6%)是最常见的不良事件。
结论
在真实世界环境中,比美吉珠单抗显示出显著的有效性和可接受的安全性。基线PASI、指甲受累情况和既往生物制剂治疗失败影响早期治疗反应。识别ESR和不良事件的预测因素可以指导个性化治疗方法,优化银屑病患者的治疗效果。