Foti Roberta, Amato Giorgio, Visalli Elisa, Bosco Ylenia Dal, Lucia Francesco De, Montana Angelo, Privitera Giambattista, Romeo Placido, Aiello Fabio, Paolì Maria Gabriella, Foti Rosario
Division of Rheumatology, AOU Policlinico "G. Rodolico" San Marco, 95121 Catania, Italy.
University of Enna "Kore", 94100 Enna, Italy.
J Clin Med. 2025 May 1;14(9):3151. doi: 10.3390/jcm14093151.
Axial involvement in psoriatic arthritis (axPsA) presents clinical and radiological differences from ankylosing spondylitis (AS), which may influence the therapeutic response. While Guselkumab has demonstrated efficacy in peripheral PsA, its role in axPsA is less well established, particularly in real-world settings. To evaluate the positive effects of Guselkumab therapy in patients with psoriatic arthritis (PsA), 58.6% of whom have axial involvement, in a 12-month, single-center, longitudinal, prospective observational cohort study conducted in a real-life setting. A cohort of 99 patients with PsA, including 58 with axial involvement (axPsA), was treated with Guselkumab for 12 months. Treatment efficacy was assessed by evaluating the reduction in mBASDAI, ASDAS, DAPSA, VAS Pain, LEI, and HAQ scores. The Friedman test was used to analyze whether the overall changes from baseline to 12 months were statistically significant. Patients with axial involvement were assessed by MRI, with scores measured at baseline (t), after 6 months (t), and after 12 months (t) of therapy. Statistical evaluation was conducted using the Friedman test, followed by pairwise comparisons of values obtained at different follow-up time points using the Wilcoxon signed-rank test. Additionally, the drug's retention rate was examined using a Kaplan-Meier curve. After 12 months of therapy, a statistically significant reduction was observed in all clinimetric parameters. Patients with axial involvement were also evaluated by MRI at baseline, after 6 months, and after 12 months of therapy. MRI images showed a reduction in bone marrow edema and a decrease in signal intensity, indicating a significant reduction in inflammation and confirming the drug's efficacy. Retention rate values demonstrate that Guselkumab is well tolerated and effective in the long term for the majority of patients. This 12-month real-world study of 99 PsA patients confirms the efficacy of Guselkumab in reducing disease activity in both peripheral and axial forms. The findings align with previous RWE and clinical trials (DISCOVER-1 and -2), supporting its clinical utility in PsA and axPsA, with high treatment retention.
银屑病关节炎(axPsA)的轴向受累在临床和影像学上与强直性脊柱炎(AS)存在差异,这可能会影响治疗反应。虽然古塞库单抗已在银屑病关节炎外周型(PsA)中显示出疗效,但其在axPsA中的作用尚未完全明确,尤其是在真实世界环境中。为了评估古塞库单抗治疗对银屑病关节炎(PsA)患者的积极效果,在一项为期12个月、单中心、纵向、前瞻性观察队列研究中进行了评估,这些患者中有58.6%存在轴向受累,研究在真实生活环境中开展。一组99例银屑病关节炎患者,其中58例有轴向受累(axPsA),接受了12个月的古塞库单抗治疗。通过评估最小疾病活动度(mBASDAI)、强直性脊柱炎疾病活动度评分(ASDAS)、疾病活动度银屑病关节炎指数(DAPSA)、视觉模拟疼痛评分(VAS Pain)、疾病活动度线性评估(LEI)和健康评估问卷(HAQ)评分的降低情况来评估治疗效果。采用弗里德曼检验分析从基线到12个月的总体变化是否具有统计学意义。对有轴向受累的患者进行磁共振成像(MRI)评估,在治疗基线(t)、6个月后(t)和12个月后(t)测量评分。使用弗里德曼检验进行统计评估,随后使用威尔科克森符号秩检验对在不同随访时间点获得的值进行成对比较。此外,使用卡普兰 - 迈耶曲线检查药物的留存率。治疗12个月后,所有临床测量参数均出现具有统计学意义的降低。对有轴向受累的患者在治疗基线、6个月后和12个月后也进行了MRI评估。MRI图像显示骨髓水肿减轻,信号强度降低,表明炎症明显减轻,证实了药物的疗效。留存率值表明,对于大多数患者来说,古塞库单抗耐受性良好且长期有效。这项对99例银屑病关节炎患者进行的为期12个月的真实世界研究证实了古塞库单抗在降低外周型和轴向型疾病活动度方面的疗效。这些发现与之前的真实世界证据(RWE)和临床试验(DISCOVER - Ⅰ和 - Ⅱ)一致,支持其在银屑病关节炎和axPsA中的临床应用价值,且治疗留存率高。