Department of Clinical and Experimental Medicine, Rheumatology Research Unit, Early Psoriatic Arthritis Clinic, University Federico II, via Sergio Pansini no. 5, Naples, Italy.
Clin Rheumatol. 2011 Aug;30(8):1063-7. doi: 10.1007/s10067-011-1680-y. Epub 2011 Mar 1.
The objective of this study is to assess the effectiveness and safety of TNF-α blockers in a group of early psoriatic arthritis (PsA) patients with an unsatisfactory response to previous conventional treatment consecutively enrolled in five Italian centres. A 24-week open-label trial was carried out in consecutive early PsA patients classified according to the CASPAR criteria, with unsatisfactory response to previous treatments and with a DAS28 threshold as ≥3.2, seen at the outpatient clinics of each centre. Exclusion criteria were previous usage of TNF-α blockers and a disease duration >12 months. The choice of any of the three TNF-α blockers was decided by the expert's opinion, without any restriction. Effectiveness was considered as an improvement of DAS28 at 12 and 24 weeks of treatment. Secondary endpoints were an improvement of TJC, SWJ, HAQ score and PASI score. Changes from baseline to the 12- and 24-week follow-up assessments were analysed using the Wilcoxon paired sign rank test. Twenty-nine patients (14 males, 15 females, median age 37 years, range 20-65 years) were enrolled. A statistical improvement of the DAS28 was observed at 12 and 24 weeks from baseline (p<0.001). Secondary endpoints also confirmed the effectiveness of the TNF-α blockers in the treatment of early PsA. No severe adverse events were observed during the treatment period, and no patient withdrew from the medications. This study suggests that the TNF-α blockers can be effective in the management of early PsA. Further controlled studies will provide more data on this challenging topic.
本研究旨在评估 TNF-α 阻滞剂在五家意大利中心连续纳入的一组先前常规治疗反应不佳的早期银屑病关节炎 (PsA) 患者中的疗效和安全性。对符合 CASPAR 标准的早期 PsA 患者进行了为期 24 周的开放性试验，这些患者以前的治疗反应不佳，且 DAS28 阈值≥3.2，在每个中心的门诊就诊。排除标准为先前使用过 TNF-α 阻滞剂和疾病持续时间>12 个月。任何三种 TNF-α 阻滞剂的选择均由专家意见决定，不受任何限制。疗效被认为是治疗 12 周和 24 周时 DAS28 的改善。次要终点是 TJC、SWJ、HAQ 评分和 PASI 评分的改善。使用 Wilcoxon 配对符号秩检验分析从基线到 12 周和 24 周随访评估的变化。共纳入 29 例患者（男性 14 例，女性 15 例，中位年龄 37 岁，范围 20-65 岁）。从基线开始，DAS28 在 12 周和 24 周时观察到统计学改善（p<0.001）。次要终点也证实了 TNF-α 阻滞剂在治疗早期 PsA 中的有效性。在治疗期间未观察到严重不良事件，也没有患者停止用药。本研究表明，TNF-α 阻滞剂可有效治疗早期 PsA。进一步的对照研究将为这一具有挑战性的课题提供更多数据。
