Objective To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). Methods Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates. Results At 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: –0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was –0.22 (95% CI –0.38 to –0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: –1.9% versus 1.6% (adjusted difference for etanercept minus control: –4.7%,95% CI –9.9 to 0.5, p=0.07) for change in mNY criteria; –1.9% versus 7.8% (adjusted difference: –18.2%,95% CI –30.9 to –5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and –0.6% versus 6.7% (adjusted difference: –16.4%,95% CI –27.9 to –5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change. Conclusion Despite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy. Trial registration numbers NCT01258738, NCT01648907; Post-results.

中文翻译：

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与当代对照队列（DESIR 队列）相比，依那西普治疗 2 年（EMBARK 试验）后结构放射学骶髂关节损伤的变化评估在最近发作的轴性脊柱关节炎中

目的 比较在临床试验 (EMBARK) 中接受依那西普治疗的近期发病的中轴性脊柱关节炎 (axSpA) 患者与队列研究 (DESIR) 中未接受生物制剂的类似患者的 2 年放射学骶髂关节 (SIJ) 变化。方法 终点是第 104 周根据改良的纽约 (mNY) 分级系统在总 SIJ 评分（主要终点）和进展患者的净百分比方面的变化，定义为三种方式。在调整和不调整基线协变量的情况下分析治疗效果。结果 在 104 周时，依那西普组的总 SIJ 评分有所改善（n=154，调整后的最小二乘均值变化：–0.14），而对照组的 SIJ 评分恶化（n=182，变化：0.08）。调整后的组间差异（依那西普减去对照）为 –0.22（95% CI –0.38 至 –0.06），p=0.008。对于三个二元终点中的两个，依那西普组进展患者的净百分比显着低于对照组：–1.9% 与 1.6%（依那西普减去对照的调整差异：–4.7%，95% CI –9.9 至 0.5， p=0.07) 表示 mNY 标准的变化；–1.9% 与 7.8%（调整后的差异：–18.2%,95% CI –30.9 至 –5.6，p=0.005）对于≥1 SIJ 中≥1 级的变化；和 –0.6% 与 6.7%（调整后的差异：–16.4%,95% CI –27.9 至 –5.0，p=0.005）对于≥1 SIJ 中≥1 级的变化，从 0 到 1 或 1 到 0 的转变被认为没有改变。结论 尽管 axSpA 的放射学 SIJ 进展率在 2 年内缓慢，但该研究表明，使用依那西普的 SIJ 进展率低于不使用抗肿瘤坏死因子治疗的情况。试验注册号NCT01258738、NCT01648907；后结果。