Effects of Secukinumab on Enthesiophyte and Erosion Progression in Psoriatic Arthritis: A One-Year Double-Blind, Randomized, Placebo-Controlled Trial Using High-Resolution Peripheral Quantitative Computed Tomography.

Methods

This was a phase 4, double-blind, randomized, placebo-controlledtrial. Patients with active PsA and ≥1 erosion in metacarpophalangeal joints (MCPJs) 2 to 4 were randomly assigned in a 1:1 ratio to subcutaneous secukinumab or placebo.

这是一项第四阶段、双盲、随机、安慰剂对照试验。具有活跃PsA和≥1侵蚀的患者在第2至第4掌指关节（MCPJs）中被随机分配为皮下注射Secukinumab或安慰剂，比例为1:1。

HR-pQCT of MCPJs 2 to 4 were performed at baseline, week 24, and week 48.

在基线、第24周和第48周对第2至第4近端指间关节(MCPJs)进行了高分辨率外周定量计算机断层扫描(HR-pQCT)。

The primary outcome was the changes in the volume of erosions on MCPJs 2 to 4 measured by HR-pQCT at 24 and 48 weeks.

主要结果是通过高分辨率外周定量计算机断层扫描(HR-pQCT)测量的第24周和第48周第2至第4近端指间关节(MCPJs)侵蚀体积的变化。

Results

Forty patients (mean ± SD age 51.9 ± 13.4 years, 20 [50%] male, mean ± SD disease duration 4.7 ± 6.7 years) were recruited.

招募了40名患者（平均年龄51.9±13.4岁，20名[50%]为男性，平均病程4.7±6.7年）

Thirty-four patients who completed study treatment were included in the per-protocol analysis.

完成研究治疗的34名患者被纳入按方案分析。

At baseline, week 24, and week 48, the secukinumab group showed a significant reduction in erosion volume, whereas no changes were observed in the placebo group (median change in the secukinumab group -0.1 [interquartile range -0.5 to 0.0] vs 0.0 [interquartile range -0.2 to 0.4] in the placebo group, P = 0.004).

在基线、第24周和第48周时，secukinumab组显示出侵蚀体积显著减少，而安慰剂组没有观察到变化（secukinumab组中位数变化-0.1 [四分位数间距-0.5至0.0]，安慰剂组为0.0 [四分位数间距-0.2至0.4]，P = 0.004）。

A similar trend was observed for enthesiophyte volume changes in the secukinumab group, whereas no differences were noted in the placebo group (median change in the secukinumab group -0.1 [interquartile range -0.8 to 0.0] vs 0.0 [interquartile range -0.4 to 1.3] in the placebo group, P = 0.067).

secukinumab组在附着点骨赘体积变化上也显示出类似趋势，而安慰剂组没有差异（secukinumab组中位数变化-0.1 [四分位数间距-0.8至0.0]，安慰剂组为0.0 [四分位数间距-0.4至1.3]，P = 0.067）。

Generalized estimating equations results showed that the odds ratio (OR) for enthesiophyte progression in the secukinumab group was 0.264 (95% confidence interval[CI] 0.080-0.878, P = 0.030), whereas the OR for partial erosion healing in the secukinumab group was 2.882 (95% CI 1.130-7.349, P = 0.027).

广义估计方程结果显示，在接受Secukinumab治疗的组中，附着点骨赘进展的几率比（OR）为0.264（95%置信区间[CI] 0.080-0.878, P = 0.030），而在接受Secukinumab治疗的组中，部分侵蚀愈合的几率比（OR）为2.882（95% CI 1.130-7.349, P = 0.027）。

Conclusions

Secukinumab demonstrates a potential benefit in facilitating partial erosion repair and preventing enthesiophyte progression in PsA.

Secukinumab在促进银屑病关节炎（PsA）部分侵蚀修复和预防附着点骨赘进展方面显示出潜在的益处。