Response of ultrasound-assessed synovitis to baricitinib, in monotherapy and combined with methotrexate, compared with etanercept in rheumatoid arthritis: a randomised, international, multicentre trial.

Methods

Adult patients with active RA and inadequate response to MTX were randomised into 3 parallel treatment groups: baricitinib monotherapy, baricitinib plus MTX, and etanercept plus MTX.

对甲氨蝶呤（MTX）反应不足的活跃RA成人患者被随机分配到3个平行治疗组：baricitinib单药治疗、baricitinib加MTX和etanercept加MTX。

The patients underwent clinical, ultrasound, and laboratory assessments at baseline, 4, 12, and 24 weeks.

患者在基线、4周、12周和24周接受了临床、超声和实验室评估。

Ultrasound synovitis was scored 0 to 3 in B-mode, Doppler mode, and a combination of both modes.

在B模式、多普勒模式以及两者结合的模式下，超声滑膜炎评分从0到3。

The primary endpoint was the change in the Global European Alliance of Associations for Rheumatology-Outcome Measures in Rheumatology Synovitis Score (GLOESS) for bilateral wrist and metacarpophalangeal joints at week 12.

主要终点是第12周时双侧腕关节和掌指关节的欧洲风湿病联盟-风湿病关节炎滑膜炎评分（GLOESS）的变化。

Noninferiority was stated if the changes in the baricitinib groups were above the lower limit of the noninferiority range, defined as 80% of changes observed in the etanercept plus MTX group.

如果巴瑞替尼组的变化高于非劣效范围的下限，即80%的依那西普加MTX组观察到的变化，则声明非劣效性。

Changes in serum concentrations of different mediators were analysed at 24 weeks.

在24周时分析了不同介质血清浓度的变化。

Results

One hundred fifty patients (109 women and 41 men) were randomised.

随机化了一百五十名患者（109名女性和41名男性）。

All clinical and ultrasound variables showed significant improvement starting from week 4 across the 3 treatment arms (P < .050).

所有临床和超声变量从第4周开始在三个治疗组中均显示出显著改善（P < .050）。

Noninferiority of baricitinib (monotherapy and plus MTX) was confirmed against etanercept with MTX for GLOESS at week 12 (P < .050).

在第12周时，巴瑞替尼（单药治疗和联合甲氨蝶呤）对于GLOESS的非劣效性相对于依那西普联合甲氨蝶呤得到了证实（P < .050）。

Changes in metalloprotease-3 concentration significantly correlated with changes in all ultrasound scores.

金属蛋白酶-3浓度的变化与所有超声评分的变化显著相关。

Conclusions

The response of ultrasound-assessed synovitis to baricitinib, alone or in combination with MTX, was noninferior to that of etanercept with MTX.

单独使用或与MTX联合使用的baricitinib对超声评估的滑膜炎的反应，与etanercept联合MTX的反应相当。