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现实环境中比美吉珠单抗的长期疗效和安全性:一项为期52周的前瞻性研究。

Long-term efficacy and safety of bimekizumab in real-world setting: a 52-week prospective study.

作者信息

Potestio Luca, Ruggiero Angelo, Martora Fabrizio, Megna Matteo

机构信息

Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Napels, Italy.

出版信息

Arch Dermatol Res. 2024 Dec 12;317(1):102. doi: 10.1007/s00403-024-03594-w.

Abstract

Bimekizumab, is the most recent monoclonal antibody licensed for the management of moderate-to-severe plaque psoriasis, acting through the dual inhibition of interleukin (IL)-17 A and IL17F, setting it apart from other anti-IL17 biologics. To date, long-term data on the use of bimekizumab for the management of plaque psoriasis in a real-world setting are scant. The aim of our study was to evaluate the effectiveness and safety of bimekizumab in long-term. A monocentric prospective study enrolling patients with moderate-to-severe plaque psoriasis undergoing treatment with bimekizumab for plaque psoriasis and with a follow-up of at least one year was performed. At baseline, demographic and clinical data were collected. Clinical data were evaluated at each follow-up visit [week (W)16-36-52]. A total of 43 patients respected the inclusion and exclusion criteria. At baseline, mean PASI and DLQI were 17.4 ± 8.3 and 24.1 ± 5.3, respectively. A statistically significant improvement of both scores was reported since W16 (PASI: 0.8 ± 1.4; DLQI: 0.9 ± 1.5, p < 0.0001), continuing to improve up to W52 (PASI: 0.4 ± 0.7; DLQI: 0.2 ± 0.4, p < 0.0001 (Table 1), with 33 (76.7%) and 29 (67.4%) subjects reaching PASI90/100 response at W16, and 36 (83.7%) and 31 (72.1%) patients achieving these results at W52. Regarding safety data, 3 (7.0%) eczematous reaction and 4 (9.3%) candidiasis were collected, with 1 patient developing both events at the same time. A total of 6 (14.0%) patients interrupted treatment: 4 (9.3%) for adverse events and 2 (4.6%) for treatment failure, respectively. Our experience confirmed the effectiveness and safety of bimekizumab in real-life, also in long-term, suggesting this drug as a valuable in the therapeutic landscape of psoriatic disease.

摘要

比美吉珠单抗是最近获批用于治疗中度至重度斑块状银屑病的单克隆抗体,它通过双重抑制白细胞介素(IL)-17A和IL-17F发挥作用,这使其有别于其他抗IL-17生物制剂。迄今为止,关于比美吉珠单抗在现实环境中用于治疗斑块状银屑病的长期数据很少。我们研究的目的是评估比美吉珠单抗的长期有效性和安全性。我们进行了一项单中心前瞻性研究,纳入接受比美吉珠单抗治疗斑块状银屑病且随访至少一年的中度至重度斑块状银屑病患者。在基线时,收集了人口统计学和临床数据。在每次随访(第16、36、52周)时评估临床数据。共有43例患者符合纳入和排除标准。在基线时,平均银屑病面积和严重程度指数(PASI)和皮肤病生活质量指数(DLQI)分别为17.4±8.3和24.1±5.3。自第16周起报告这两项评分均有统计学显著改善(PASI:0.8±1.4;DLQI:0.9±1.5,p<0.0001),直至第52周持续改善(PASI:0.4±0.7;DLQI:0.2±0.4,p<0.0001(表1)),在第16周时分别有33例(76.7%)和29例(67.4%)受试者达到PASI90/100缓解,在第52周时分别有36例(83.7%)和31例(72.1%)患者达到这些结果。关于安全性数据,收集到3例(7.0%)湿疹反应和4例(9.3%)念珠菌病,有1例患者同时发生这两种情况。共有6例(14.0%)患者中断治疗:分别有4例(9.3%)因不良事件和2例(4.6%)因治疗失败中断治疗。我们的经验证实了比美吉珠单抗在现实生活中的有效性和安全性,即使是长期使用,表明该药物在银屑病治疗领域具有重要价值。

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