bimekizumab 在老年患者中的疗效和安全性:真实世界多中心回顾性研究 - IL PSO(意大利银屑病景观)。

D Orsini, M Megna, C Assorgi, A Balato, R Balestri, N Bernardini, A Bettacchi, T Bianchelli, L Bianchi, G Buggiani, M Burlando, Amg Brunasso, G Caldarola, N Cameli, A Campanati, E Campione, A Carugno, K Chersi, A Conti, A Costanzo, E Cozzani, A Cuccia, D D'Amico, G Dal Bello, E G Dall'Olio, P Dapavo, C De Simone, E V Di Brizzi, A Di Cesare, V Dini, M Esposito, E Errichetti, M C Fargnoli, C S Fiorella, A Foti, Z Fratton, F M Gaiani, P Gisondi, R Giuffrida, A Giunta, C Guarneri, A Legori, F Loconsole, P Malagoli, A Narcisi, M Paolinelli, L Potestio, F Prignano, G Rech, A Rossi, N Skroza, F Trovato, M Venturini, A G Richetta, G Pellacani, A Dattola
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At baseline and each dermatological examination (4, 16, and 36 weeks), clinical outcomes were measured by the following parameters: (1) PASI score; (2) site-specific (scalp, palmoplantar, genital, nail) Psoriasis Global Assessment (PGA). At each visit, the occurrence of any adverse events (AEs) was recorded, including serious AEs and AEs leading to bimekizumab discontinuation.</p><p><p><b>Results:</b> The mean PASI score was 16.6 ± 9.4 at baseline and significantly decreased to 4.3 ± 5.2 after 4 weeks (<i>p</i> < 0.001), and 1.1 ± 1.7 after 16 week (<i>p</i> < 0.001). This level of improvement was maintained after 36 weeks (<i>p</i> < 0.001). PASI ≤2 was recorded in 36 (36.7%) at week 4, 68% and 69.4% at week 16 and 36, respectively. By week 16, 86/98 (87.8%) patients reached PASI75, 71/98 (72.4%) obtained PASI90, and 52/98 (53.1%) PASI100. Binary logistic regression tests showed a significant association of PASI100 by week 4 with lower PASI at baseline. 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引用次数: 0

摘要

文章目的这项多中心观察性研究旨在报告在年龄≥65岁的中重度斑块状银屑病患者中使用比美单抗的实际数据。老年患者在比美珠单抗治疗斑块状银屑病的临床试验中比例较低,因此真实世界的研究对于指导临床选择非常重要:在意大利的 33 家皮肤科门诊诊所开展了一项回顾性多中心研究。研究对象包括年龄≥ 65 岁、患有中度至重度斑块状银屑病并接受过 bimekizumab 治疗的患者。无排除标准。比美珠单抗按照意大利斑块状银屑病治疗指南和产品特性概要进行治疗,适用于接受全身治疗的成年患者。共有98名受试者接受了bimekizumab治疗,疗程持续到第36周。在开始使用bimekizumab治疗前收集了临床和人口统计学数据。在基线和每次皮肤检查(4、16 和 36 周)时,临床结果通过以下参数进行测量:(1) PASI 评分;(2) 特定部位(头皮、掌跖、生殖器、指甲)牛皮癣总体评估 (PGA)。在每次就诊时,记录任何不良事件(AEs)的发生情况,包括严重不良事件和导致停用比美珠单抗的不良事件:结果:基线时的平均 PASI 评分为 16.6 ± 9.4,4 周后明显降低至 4.3 ± 5.2(p p p 结论:Bimekizumab 的疗效显著:比美单抗疗效好、耐受性强、疗程方便,适合老年患者使用。
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Efficacy and Safety of bimekizumab in elderly patients: real-world multicenter retrospective study - IL PSO (Italian Landscape Psoriasis).

Purpose of the article: The aim of this multicenter observational study is to report data from real world on the use of bimekizumab in patients aged ≥ 65 years with moderate-to-severe plaque psoriasis. Elderly patients are poorly represented in clinical trials on bimekizumab for plaque psoriasis, and real-world studies are important to guide clinical choices.

Materials and methods: A retrospective multicenter study was conducted in 33 dermatological outpatient clinics in Italy. Patients aged ≥ 65 years, with moderate-to-severe plaque psoriasis and treated with bimekizumab were enrolled. No exclusion criteria were applied. Bimekizumab was administered following the Italian Guidelines for the management of plaque psoriasis and according to the summary of product characteristics, in adult patients who were candidates for systemic treatments. Overall, 98 subjects were included, and received bimekizumab up to week 36. Clinical and demographic data were collected before the initiation of treatment with bimekizumab. At baseline and each dermatological examination (4, 16, and 36 weeks), clinical outcomes were measured by the following parameters: (1) PASI score; (2) site-specific (scalp, palmoplantar, genital, nail) Psoriasis Global Assessment (PGA). At each visit, the occurrence of any adverse events (AEs) was recorded, including serious AEs and AEs leading to bimekizumab discontinuation.

Results: The mean PASI score was 16.6 ± 9.4 at baseline and significantly decreased to 4.3 ± 5.2 after 4 weeks (p < 0.001), and 1.1 ± 1.7 after 16 week (p < 0.001). This level of improvement was maintained after 36 weeks (p < 0.001). PASI ≤2 was recorded in 36 (36.7%) at week 4, 68% and 69.4% at week 16 and 36, respectively. By week 16, 86/98 (87.8%) patients reached PASI75, 71/98 (72.4%) obtained PASI90, and 52/98 (53.1%) PASI100. Binary logistic regression tests showed a significant association of PASI100 by week 4 with lower PASI at baseline. PASI 100 at 16 or 36 weeks was not associated with baseline PASI, obesity, age, gender, previously naïve state, and presence of psoriatic arthritis. Patients naïve to biologics at baseline had similar response to bimekizumab as non-naïve subjects.

Conclusions: Bimekizumab is a suitable option for elder patients as it is effective, tolerated and has a convenient schedule.

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