Psoriasis Research and Treatment Center, Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Freie Universität Berlin, Berlin, Germany.
Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089.
Discontinuation of biologics is common among patients with psoriasis due to treatment failure or adverse events. To achieve improvements in disease management, patients and clinicians may choose to switch biologics.
To evaluate the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab and secukinumab.
Data are reported for up to 80 weeks after patients switched to bimekizumab from adalimumab at week 24 in BE SURE, ustekinumab at week 52 in BE VIVID [upon entry into the BE BRIGHT open-label extension (OLE)] and secukinumab at week 48 in BE RADIANT (upon entry into the BE RADIANT OLE). Efficacy outcomes are reported by number of weeks after switching to bimekizumab and were split based on whether patients had achieved a ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at the time of switch. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Trial registration: BE SURE (NCT03412747), BE VIVID (NCT03370133), BE BRIGHT (NCT03598790), BE RADIANT (NCT03536884).
Rapid and durable improvements in clinical responses and benefits in health-related quality of life were observed among PASI 90 nonresponders who switched to bimekizumab. Most PASI 90 nonresponders achieved PASI 90 4 weeks after switching to bimekizumab from adalimumab (67%), ustekinumab (79%) and secukinumab (53%). After 48 weeks of bimekizumab, 91%, 90% and 79% of PASI 90 nonresponders had achieved PASI 90 after switching from adalimumab, ustekinumab or secukinumab, respectively. Durable improvements were also observed for PASI 100, Investigator's Global Assessment score 0/1, body surface area affected by psoriasis ≤ 1%, absolute PASI ≤ 2, and Dermatology Life Quality Index 0/1. Among PASI 90 responders, existing treatment responses were maintained or improved after switching to bimekizumab. The majority of TEAEs were mild or moderate. EAIRs were generally similar between active-comparator treatment periods and after switching to bimekizumab. EAIRs typically decreased with a longer duration of bimekizumab exposure.
High proportions of patients who did not adequately respond to adalimumab, ustekinumab or secukinumab achieved high levels of skin clearance after switching to bimekizumab. Bimekizumab was well tolerated and there were no new safety findings.
由于治疗失败或不良反应，许多银屑病患者会停止使用生物制剂。为了改善疾病管理，患者和临床医生可能会选择更换生物制剂。
评估从阿达木单抗、乌司奴单抗和司库奇尤单抗转换为比美吉珠单抗的疗效和安全性。
患者在第 24 周从阿达木单抗转换为比美吉珠单抗的 BE SURE 、第 52 周从乌司奴单抗转换为比美吉珠单抗的 BE VIVID[进入 BE BRIGHT 开放标签扩展（OLE）]和第 48 周从司库奇尤单抗转换为比美吉珠单抗的 BE RADIANT（进入 BE RADIANT OLE）后，报告最多 80 周的数据。根据转换时是否达到银屑病面积和严重程度指数（PASI 90）较基线改善≥90%，按转换后治疗周数报告疗效结局。使用暴露调整发病率（EAIR）每 100 患者-年报告治疗中出现的不良事件（TEAEs）。试验注册：BE SURE（NCT03412747）、BE VIVID（NCT03370133）、BE BRIGHT（NCT03598790）、BE RADIANT（NCT03536884）。
在从阿达木单抗、乌司奴单抗和司库奇尤单抗转换为比美吉珠单抗的 PASI 90 无应答者中，观察到临床应答和健康相关生活质量获益的快速和持久改善。大多数 PASI 90 无应答者在从阿达木单抗转换为比美吉珠单抗后的 4 周内达到 PASI 90（67%）、乌司奴单抗（79%）和司库奇尤单抗（53%）。在接受比美吉珠单抗治疗 48 周后，分别有 91%、90%和 79%的 PASI 90 无应答者从阿达木单抗、乌司奴单抗或司库奇尤单抗转换后达到 PASI 90。PASI 100、研究者整体评估 0/1、受银屑病影响的体表面积≤1%、绝对 PASI≤2 和皮肤病生活质量指数 0/1 也观察到持久改善。在 PASI 90 应答者中，转换为比美吉珠单抗后维持或改善了现有治疗反应。大多数 TEAEs 为轻度或中度。活性对照治疗期和转换为比美吉珠单抗后的 EAIR 通常相似。EAIR 通常随着比美吉珠单抗暴露时间的延长而降低。
在从阿达木单抗、乌司奴单抗或司库奇尤单抗转换为比美吉珠单抗的患者中，相当大比例的未充分应答者在转换后达到了较高的皮肤清除水平。比美吉珠单抗耐受性良好，未发现新的安全性发现。
