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欧洲真实世界中患有中轴型脊柱关节炎和银屑病关节炎患者的司库奇尤单抗四年治疗结果。

Four-year secukinumab treatment outcomes in European real-world patients with axial spondyloarthritis and psoriatic arthritis.

作者信息

Pons Marion, Georgiadis Stylianos, Østergaard Mikkel, Ahmadzay Zohra Faizy, Glintborg Bente, Heberg Jette, Christensen Sara Nysom, Rasmussen Simon, Loft Anne Gitte, Castrejón Isabel, Sánchez-Alonso Fernando, Iannone Florenzo, Nordström Dan, Hokkanen Anna-Mari, Ciurea Adrian, Nissen Michael J, Závada Jakub, Pavelka Karel, Rotar Ziga, Pirkmajer Katja Perdan, Michelsen Brigitte, Mielnik Pawel, Bernardes Miguel, Khmelinskii Nikita, Laas Karin, Vorobjov Sigrid, Codreanu Catalin, Macfarlane Gary J, Jones Gareth T, Gudbjornsson Bjorn, Palsson Olafur, Wallman Johan K, van der Horst-Bruinsma Irene, Onen Fatos, Hetland Merete Lund, Ørnbjerg Lykke Midtbøll

机构信息

Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopedics, Rigshospitalet, Glostrup, Denmark.

Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopedics, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

出版信息

Joint Bone Spine. 2025 May;92(3):105824. doi: 10.1016/j.jbspin.2024.105824. Epub 2024 Nov 26.

Abstract

OBJECTIVES

In axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) patients initiating secukinumab, we aimed to assess retention rates and proportions of patients achieving remission and low disease activity (LDA), according to disease activity measures and patient-reported outcomes at 24 and 48 months.

PATIENTS AND METHODS

Data on patients with axSpA and PsA who initiated secukinumab treatment were pooled from 13 European registries. Analyses were performed overall and stratified according to the number of previous biologic/targeted synthetic Disease-Modifying Antirheumatic Drugs (b/tsDMARDs, 0/1/≥2). Kaplan-Meier plots and Cox regression analyses were performed to assess and compare secukinumab retention rates. Comparisons of remission and LDA rates were performed by logistic regression analyses.

RESULTS

The overall 24-/48-month secukinumab retention rates were 61%/51% in 767 axSpA patients, and 64%/49% in 975 PsA patients, respectively. Compared to b/tsDMARD naïve patients, a higher risk of withdrawal from secukinumab was found for those with≥2 prior b/tsDMARDs in axSpA and PsA, and 1 prior b/tsDMARD in axSpA. Generally, remission and LDA rates were numerically higher in b/tsDMARD naïve patients. After adjustment for confounders, statistically significantly higher remission and LDA rates were found for b/tsDMARD naïve patients compared to patients with≥ 2 prior b/tsDMARDs at 24 months in axSpA and PsA.

CONCLUSION

This large European real-world study demonstrates that 4-year secukinumab retention rates were approximately 50% in both axSpA and PsA. b/tsDMARD naïve patients had higher retention, remission and LDA rates than patients with prior b/tsDMARD exposure.

摘要

目的

在开始使用司库奇尤单抗治疗的中轴型脊柱关节炎(axSpA)和银屑病关节炎(PsA)患者中,我们旨在根据24个月和48个月时的疾病活动度测量指标及患者报告结局,评估留存率以及达到缓解和低疾病活动度(LDA)的患者比例。

患者与方法

从13个欧洲登记处汇总了开始司库奇尤单抗治疗的axSpA和PsA患者的数据。总体进行分析,并根据既往生物制剂/靶向合成改善病情抗风湿药物(b/tsDMARDs,0/1/≥2)的使用数量进行分层。采用Kaplan-Meier曲线和Cox回归分析来评估和比较司库奇尤单抗的留存率。通过逻辑回归分析对缓解率和LDA率进行比较。

结果

767例axSpA患者的司库奇尤单抗总体24个月/48个月留存率分别为61%/51%,975例PsA患者的留存率分别为64%/49%。与未使用过b/tsDMARDs的患者相比,axSpA和PsA中既往使用过≥2种b/tsDMARDs的患者以及axSpA中既往使用过1种b/tsDMARDs的患者停用司库奇尤单抗的风险更高。一般而言,未使用过b/tsDMARDs的患者缓解率和LDA率在数值上更高。在对混杂因素进行调整后,发现在axSpA和PsA中,与既往使用过≥2种b/tsDMARDs的患者相比,未使用过b/tsDMARDs的患者在24个月时的缓解率和LDA率在统计学上显著更高。

结论

这项大型欧洲真实世界研究表明,axSpA和PsA患者中司库奇尤单抗4年留存率约为50%。未使用过b/tsDMARDs患者的留存率、缓解率和LDA率高于既往使用过b/tsDMARDs的患者。

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