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司库奇尤单抗在不同临床表型银屑病关节炎中的疗效和保留率:来自意大利GISEA注册研究的见解

Efficacy and retention rate of secukinumab in psoriatic arthritis across different clinical phenotypes: insights from the Italian GISEA Registry.

作者信息

Lopalco Giuseppe, Morrone Maria, Atzeni Fabiola, Bazzani Chiara, Bianchi Francesco Paolo, Cantatore Francesco Paolo, Caporali Roberto, Carletto Antonio, Cauli Alberto, Chimenti Maria Sole, Colella Sergio, Conti Fabrizio, Corrado Addolorata, Favalli Ennio Giulio, Floris Alberto, Fornaro Marco, Foti Rosario, Foti Roberta, Fracassi Elena, Frediani Bruno, Gentileschi Stefano, Gorla Roberto, Gremese Elisa, Praino Emanuela, Ramonda Roberta, Rotondo Cinzia, Sebastiani Marco, Semeraro Angelo, Ferraccioli Gianfranco, Lapadula Giovanni, Iannone Florenzo

机构信息

Rheumatology Unit, Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Piazza G. Cesare 11, Bari 70124, Italy.

Rheumatology Unit, Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Bari, Italy.

出版信息

Ther Adv Musculoskelet Dis. 2025 Jan 31;17:1759720X251315138. doi: 10.1177/1759720X251315138. eCollection 2025.

Abstract

BACKGROUND

Randomized clinical trials have demonstrated the efficacy of secukinumab (SECU) in reducing disease activity in psoriatic arthritis (PsA), while real-world studies prove a broader perspective on SECU's usefulness in everyday clinical practice.

OBJECTIVES

To assess the effectiveness of SECU by evaluating drug survival and identifying potential predictors of clinical response and treatment discontinuation in patients with moderate-to-severe PsA, using real-world data from the Italian Group for the Study of Early Arthritis (GISEA) registry.

DESIGN

This longitudinal retrospective study included PsA patients treated with SECU, spanning from May 2016 to November 2023.

METHODS

Data from 1045 PsA patients, including 783 with peripheral-only PsA (perPsA) and 262 with peripheral and axial involvement (mixed PsA) were analyzed. Drug survival was estimated by Kaplan-Meier analysis. Clinical outcomes, including Disease Activity Index for Psoriatic Arthritis (DAPSA), Psoriasis Area Severity Index (PASI), Ankylosing Spondylitis Disease Activity Score (ASDAS, C-Reactive Protein (CRP)-based), and Visual Analogue Scale (VAS) measures, were evaluated at baseline and at 6, 12, and 24 months. Adjusted hazard ratios (aHRs) for discontinuing SECU were determined using multivariate Cox regression models.

RESULTS

SECU survival at 24 months was 63.24%, significantly higher in mixed PsA compared to perPsA ( = 0.036). In the overall PsA population, DAPSA scores decreased significantly at 6 months, and further at 24 months (all  < 0.0001). In mixed PsA, ASDAS-CRP scores were significantly reduced at 6 months and remained stable through 24 months (all  < 0.0001). VAS pain scores also improved already at 6 months and continued to improve at 24 months (all  < 0.0001). Higher age (aHR = 0.98, 95% confidence interval (CI): 0.96-0.99,  = 0.007) and lower baseline DAPSA scores (aHR = 1.02, 95% CI: 1.01-1.03,  = 0.014) were associated with greater persistence of SECU treatment. SECU was well tolerated, with no serious adverse events.

CONCLUSION

SECU showed sustained clinical improvements in both peripheral and axial involvement of PsA patients over 24 months, with higher persistence observed in mixed PsA patients. Our findings highlight the favorable clinical and safety profile of SECU in real world.

摘要

背景

随机临床试验已证明司库奇尤单抗(SECU)在降低银屑病关节炎(PsA)疾病活动度方面的疗效,而真实世界研究则更广泛地展现了SECU在日常临床实践中的实用性。

目的

利用来自意大利早期关节炎研究组(GISEA)登记处的真实世界数据,通过评估药物留存率并确定中重度PsA患者临床反应和治疗中断的潜在预测因素,来评估SECU的有效性。

设计

这项纵向回顾性研究纳入了2016年5月至2023年11月期间接受SECU治疗的PsA患者。

方法

分析了1045例PsA患者的数据,其中包括783例仅外周型PsA(perPsA)患者和262例外周及中轴受累(混合型PsA)患者。通过Kaplan-Meier分析估计药物留存率。在基线以及6、12和24个月时评估临床结局,包括银屑病关节炎疾病活动指数(DAPSA)、银屑病面积和严重程度指数(PASI)、基于C反应蛋白(CRP)的强直性脊柱炎疾病活动评分(ASDAS)以及视觉模拟量表(VAS)测量值。使用多变量Cox回归模型确定停用SECU的调整后风险比(aHRs)。

结果

24个月时SECU留存率为63.24%,混合型PsA患者的留存率显著高于perPsA患者(P = 0.036)。在整个PsA患者群体中,DAPSA评分在6个月时显著下降,在24个月时进一步下降(均P < 0.0001)。在混合型PsA患者中,ASDAS-CRP评分在6个月时显著降低,并在24个月内保持稳定(均P < 0.0001)。VAS疼痛评分在6个月时已经改善,并在24个月时持续改善(均P < 0.0001)。年龄较大(aHR = 0.98,95%置信区间(CI):0.96 - 0.99,P = 0.007)和基线DAPSA评分较低(aHR = 1.02,95%CI:1.01 - 1.03,P = 0.014)与SECU治疗的持续时间更长相关。SECU耐受性良好,未发生严重不良事件。

结论

SECU在24个月内使PsA患者的外周和中轴受累情况均持续获得临床改善,混合型PsA患者的药物留存率更高。我们的研究结果突出了SECU在真实世界中的良好临床和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2ce/11783553/a0d507a2c505/10.1177_1759720X251315138-fig1.jpg

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