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替拉珠单抗治疗掌跖受累斑块状银屑病的真实生活经验:一项意大利多中心回顾性研究

Real-Life Experience with Tildrakizumab in Plaque Psoriasis with Palmoplantar Involvement: A Multi-Center Retrospective Italian Study.

作者信息

Diotallevi Federico, Esposito Maria, Fargnoli Maria Concetta, Quaglino Pietro, Mastorino Luca, Stingeni Luca, Hansel Katharina, Feliciani Claudio, Megna Matteo, Gallo Lucia, Legori Agostina, Argenziano Giuseppe, Balato Anna, Bardazzi Federico, Burlando Martina, Cozzani Emanuele, Bianchi Luca, Galluzzo Marco, Gisondi Paolo, Bellinato Francesco, Bianchelli Tommaso, D'Agostino Giovanni Marco, Matacchione Giulia, Campanati Anna

机构信息

Department of Clinical and Molecular Sciences-Dermatological Clinic, Università Politecnica Delle Marche, Ancona, Italy.

Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.

出版信息

Dermatol Ther (Heidelb). 2025 Feb;15(2):323-336. doi: 10.1007/s13555-025-01339-9. Epub 2025 Jan 23.

Abstract

INTRODUCTION

Palmoplantar psoriasis (PPp) has a profound negative impact on patients' quality of life, and it represents a therapeutic challenge, as palms and soles are difficult to treat area. Although the efficacy profile of tildrakizumab has been well evaluated in the literature, data on its use for PPp are still limited. The objective of the study was to evaluate the efficacy and safety of tildrakizumab on moderate-to-severe plaque psoriasis with involvement of the palmoplantar area.

METHODS

A multicenter, retrospective, real-life study was performed enrolling patients with moderate-to-severe plaque psoriasis involving the palmoplantar area undergoing treatment with tildrakizumab with a follow-up of at least 52 weeks. At baseline, demographic and clinical data were assessed. Psoriasis severity was evaluated by using Psoriasis Activity Severity Index (PASI), body surface area (BSA), Psoriasis Global Assessment (PGA), Pruritus-Numerical Rating Scale (P-NRS) and Dermatology Life Quality Index (DLQI). Palmoplantar PASI (ppPASI) was used to evaluate psoriasis severity in the palmoplantar region. Clinical improvement was evaluated at each follow-up visit [week (W) 4, 16, 52].

RESULTS

A total of 99 patients were enrolled. A reduction in PASI, BSA, PGA, P-NRS and DLQI was observed at each time point. Mean ppPASI at baseline was 16.9 ± 13.2, which started to improve at W4 (8.9 ± 9.1) and continued to decrease at W16 (2.1 ± 3.1) and W52 (0.5 ± 1.0). Moreover, a sub-analysis showed that the probability of achieving ppPASI50 at W4 increased in case of nail psoriasis (p < 0.05) and decreased in bio-experienced patients (p < 0.001). Similarly, the probability of achieving ppPASI75 at W4 decreased in the case of prior biologic exposure (p < 0.05). Finally, patients with nail psoriasis showed a higher probability of reaching ppPASI75 at W16 (p < 0.05), whereas patients previously treated with systemic therapies for psoriasis reported a reduced probability of ppPASI75 achievement at this time point (p < 0.05).

CONCLUSION

Tildrakizumab was shown to be a fast and effective treatment for patients with PPp, being able to achieve significant results already after only 4 weeks of treatment. Moreover, the identification of potential clinical factors predictive of response may improve the selection of the best treatment in patients with PPp.

摘要

引言

掌跖部银屑病(PPp)对患者的生活质量有严重负面影响,并且是一项治疗挑战,因为手掌和脚底是难以治疗的部位。尽管替拉珠单抗的疗效在文献中已得到充分评估,但其用于PPp的数据仍然有限。本研究的目的是评估替拉珠单抗对累及掌跖部的中度至重度斑块状银屑病的疗效和安全性。

方法

进行了一项多中心、回顾性、真实世界研究,纳入累及掌跖部的中度至重度斑块状银屑病且正在接受替拉珠单抗治疗的患者,随访至少52周。在基线时,评估人口统计学和临床数据。使用银屑病活动严重程度指数(PASI)、体表面积(BSA)、银屑病整体评估(PGA)、瘙痒数字评定量表(P-NRS)和皮肤病生活质量指数(DLQI)评估银屑病严重程度。掌跖部PASI(ppPASI)用于评估掌跖部区域的银屑病严重程度。在每次随访时[第4、16、52周(W)]评估临床改善情况。

结果

共纳入99例患者。在每个时间点均观察到PASI、BSA、PGA、P-NRS和DLQI降低。基线时的平均ppPASI为16.9±13.2,在第4周(W4)开始改善(8.9±9.1),并在第16周(W16)(2.1±3.1)和第52周(W52)(0.5±1.0)持续下降。此外,一项亚组分析显示,伴有甲银屑病的患者在第4周达到ppPASI50的概率增加(p<0.05),而有生物制剂治疗经验的患者概率降低(p<0.001)。同样,在既往有生物制剂暴露的情况下,第4周达到ppPASI75的概率降低(p<0.05)。最后,甲银屑病患者在第16周达到ppPASI75的概率较高(p<0.05),而既往接受过银屑病系统治疗的患者在该时间点达到ppPASI75的概率降低(p<0.05)。

结论

替拉珠单抗被证明是治疗PPp患者的一种快速有效的疗法,仅在治疗4周后就能取得显著效果。此外,识别预测反应的潜在临床因素可能会改善PPp患者最佳治疗方案的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecda/11832957/f4a422f087a4/13555_2025_1339_Fig1_HTML.jpg

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