Jensen Kasper Yde, Grøn Kathrine Lederballe, Glintborg Bente, Hetland Merete Lund
Copenhagen Center for Arthritis Research and the DANBIO Registry, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Department of Rheumatology, Rigshospitalet, Copenhagen, Denmark.
RMD Open. 2025 Jul 22;11(3):e005806. doi: 10.1136/rmdopen-2025-005806.
To explore real-world effectiveness of ixekizumab in Danish patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).
Observational cohort study based on data from the Danish nationwide quality registry, DANBIO. Patients with axSpA and PsA initiating ixekizumab (an interleukin 17 inhibitor (IL-17i)) between 2017 and 2024 were included. Outcomes were 6-, 12- and 24-month retention rates and low disease activity (LDA)/remission after 6 months (axSpA: Axial Spondyloarthritis Disease Activity Score (ASDAS) <2.1/<1.3, PsA: Disease Activity index for Psoriatic Arthritis (DAPSA28) ≤14/≤4, respectively). Clinical factors associated with retention were explored (multivariable Cox regression analyses with adjusted HRs (aHRs)).
709 patients were included (axSpA: 231, PsA: 478). Most patients were bio-experienced (axSpA: 97%, PsA: 91%). The 6-, 12- and 24-month retention rates were for axSpA: 69% (95% CI 63; 76), 53% (46; 60) and 40% (33; 49); for PsA: 75% (71; 79), 63% (58; 67) and 51% (46; 57), respectively. Patients previously treated with another IL-17i (axSpA 36%, PsA 34%) had an increased risk of withdrawal (aHR: axSpA 1.48 (1.01; 2.17), PsA 2.38 (1.79; 3.15)). Smoking, radiographic status (axSpA) or concomitant methotrexate (PsA) were not associated with withdrawal. After 6 months, 24% of axSpA patients had ASDAS-LDA, and 5% were in ASDAS-remission. For PsA, DAPSA28-LDA was achieved in 43% and DAPSA28-remission in 10%, respectively.
In this nationwide observational study, ixekizumab was primarily prescribed in patients who had failed multiple biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), including other IL-17i. Retention rates were somewhat lower for axSpA than for PsA. For both axSpA and PsA, prior IL-17i treatment was associated with an increased risk of withdrawal, yet the relatively high retention rate and improvement in all disease activity outcomes suggest ixekizumab as a viable option for patients with multiple b/tsDMARD failures.
探讨司库奇尤单抗在丹麦强直性脊柱炎（axSpA）和银屑病关节炎（PsA）患者中的真实世界疗效。
基于丹麦全国性质量登记数据库DANBIO的数据进行观察性队列研究。纳入2017年至2024年间开始使用司库奇尤单抗（一种白细胞介素17抑制剂（IL-17i））的axSpA和PsA患者。观察指标为6个月、12个月和24个月的留存率以及6个月后的低疾病活动度（LDA）/缓解情况（axSpA：强直性脊柱炎疾病活动度评分（ASDAS）<2.1/<1.3，PsA：银屑病关节炎疾病活动指数（DAPSA28）≤14/≤4）。探讨与留存相关的临床因素（采用校正风险比（aHRs）的多变量Cox回归分析）。
共纳入709例患者（axSpA：231例，PsA：478例）。大多数患者有生物制剂使用经验（axSpA：97%，PsA：91%）。axSpA患者6个月、12个月和24个月的留存率分别为69%（95%CI 63；76）、53%（46；60）和40%（33；49）；PsA患者分别为75%（71；79）、63%（58；67）和51%（46；57）。既往接受过其他IL-17i治疗的患者（axSpA 36%，PsA 34%）停药风险增加（aHR：axSpA为1.48（1.01；2.17），PsA为2.38（1.79；3.15））。吸烟、影像学状态（axSpA）或联合使用甲氨蝶呤（PsA）与停药无关。6个月后，24%的axSpA患者达到ASDAS-LDA，5%处于ASDAS缓解状态。对于PsA，分别有43%的患者达到DAPSA28-LDA，10%处于DAPSA28缓解状态。
在这项全国性观察性研究中，司库奇尤单抗主要用于多种生物制剂和靶向合成改善病情抗风湿药物（b/tsDMARDs），包括其他IL-17i治疗失败的患者。axSpA的留存率略低于PsA。对于axSpA和PsA，既往IL-17i治疗均与停药风险增加相关，但相对较高的留存率和所有疾病活动指标的改善表明，司库奇尤单抗是多种b/tsDMARDs治疗失败患者的一个可行选择。
