Felis-Giemza Anna, Stasiek Małgorzata, Palej Karolina, Wysmołek-Sołtysik Marta, Łosoś Marta, Stańczyk Sandra, Werońska-Tatara Joanna, Wroński Jakub
Biologic Therapy Center, National Institute of Geriatrics, Rheumatology and Rehabilitation, Spartańska 1, 02-637, Warsaw, Poland.
Department of Rheumatology, National Institute of Geriatrics, Rheumatology and Rehabilitation, Spartańska 1, 02-637, Warsaw, Poland.
Sci Rep. 2025 Jul 12;15(1):25212. doi: 10.1038/s41598-025-11070-2.
Advances in biologic and targeted synthetic DMARDs have expanded treatment options for spondylarthritis. Despite improvements with TNF inhibitors, many patients remain refractory. Secukinumab, an IL-17A inhibitor, has shown promise in controlled trials. This study evaluates its real-world retention, efficacy, and safety in a Polish cohort. We conducted a retrospective analysis using electronic records from the largest biological treatment center in Poland. Adult patients (≥ 18 years) who initiated secukinumab therapy under the National Health Fund program between November 2018 and October 2024 were included. Primary outcomes were overall drug survival and treatment response at 90 and 180 days. Among 279 patients (139 psoriatic arthritis, 112 ankylosing spondylitis, 28 non-radiographic spondylarthritis; median follow-up 23 months), treatment response rates were 88.2% at 3 months and 88.9% at 6 months, with significant improvements in all evaluated parameters. One-year drug survival was 87%, declining to 59% at 58 months. Dose escalation to 300 mg/month was required in 32.9% of patients, with most (77%) showing subsequent benefit. The risk factor for treatment failure was enthesitis (OR 2.2 95% CI 1.05-4.62), while the factor favoring continuing secukinumab therapy was dactylitis (OR 14.69 95% CI 1.88-114.69). Secukinumab demonstrated robust real-world efficacy, safety, and retention in spondylarthritis patients, supporting its role as an effective treatment.
生物制剂和靶向合成抗风湿药物（DMARDs）的进展扩大了脊柱关节炎的治疗选择。尽管使用肿瘤坏死因子（TNF）抑制剂后病情有所改善，但许多患者仍然难治。司库奇尤单抗是一种白细胞介素-17A（IL-17A）抑制剂，在对照试验中显示出前景。本研究评估了其在波兰队列中的实际留存率、疗效和安全性。我们使用波兰最大的生物治疗中心的电子记录进行了一项回顾性分析。纳入了2018年11月至2024年10月期间根据国家卫生基金计划开始使用司库奇尤单抗治疗的成年患者（≥18岁）。主要结局是90天和180天时的总体药物留存率和治疗反应。在279例患者中（139例银屑病关节炎、112例强直性脊柱炎、28例非放射学中轴型脊柱关节炎；中位随访23个月），3个月时的治疗反应率为88.2%，6个月时为88.9%，所有评估参数均有显著改善。一年药物留存率为87%，58个月时降至59%。32.9%的患者需要将剂量增加至300mg/月，大多数患者（77%）随后显示出获益。治疗失败的危险因素是附着点炎（比值比[OR]2.2，95%置信区间[CI]1.05 - 4.62），而有利于继续使用司库奇尤单抗治疗的因素是指（趾）炎（OR 14.69，95%CI 1.88 - 114.69）。司库奇尤单抗在脊柱关节炎患者中显示出强大的实际疗效、安全性和留存率，支持其作为一种有效治疗方法的作用。
