Upadacitinib vs adalimumab in patients with rheumatoid arthritis and a prior inadequate response or intolerance to a tumour necrosis factor inhibitor: 12-week results from the randomised, double-blind, SELECT-SWITCH study.

The ongoing SELECT-SWITCH trial compared upadacitinib with adalimumab for active RA after first TNFi failure at 12 weeks.

正在进行的SELECT-SWITCH试验比较了在首次TNFi失败后12周内，对于活跃的RA患者，Upadacitinib与阿达木单抗的效果。

Methods

Patients with inadequate response or intolerance to 1 nonadalimumab TNFi receiving stable methotrexate were randomised (1:1) to 15 mg once daily upadacitinib or 40 mg every-other-weekly adalimumab.

对一种非阿达木单抗类肿瘤坏死因子抑制剂（TNFi）反应不足或不耐受，并且正在接受稳定剂量甲氨蝶呤治疗的患者进行了随机分组（1:1），分别接受每日一次15 mg的upadacitinib或每两周一次40 mg的阿达木单抗治疗。

The primary endpoint was achieving superiority in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) ≤3.2 at week 12.

主要终点是在第12周达到疾病活动度评分28（DAS28）-C反应蛋白（CRP）≤3.2的优越性。

Ranked secondary endpoints (week 12, superiority) were (1) achieving ≥50% improvement in American College of Rheumatology response criteria (ACR50); (2) achieving DAS28-CRP <2.6; change from baseline in (3) DAS28-CRP; (4) pain; (5) Health Assessment Questionnaire Disability Index (HAQ-DI).

次要终点（第12周，优势）包括：（1）达到美国风湿病学会反应标准（ACR）50%以上的改善（ACR50）；（2）达到DAS28-CRP评分<2.6；（3）DAS28-CRP基线值的变化；（4）疼痛；（5）健康评估问卷残疾指数（HAQ-DI）的变化。

Results

Overall, 492 patients were randomised.

总体而言，共有492名患者被随机分配。

Baseline characteristics were balanced between groups.

两组基线特征均衡。

Week 12 DAS28-CRP ≤3.2 response was superior with upadacitinib (43.3%) vs adalimumab (22.4%; difference, 21.0% [95% CI: 12.9-29.1]; P < .0001) as were ACR50 (38.2% vs 26.8% [P = .0068]), DAS28-CRP <2.6 (28.4% vs 14.5%; P = .0002), mean changes in DAS28-CRP (-2.432 vs -1.840; P < .0001) and pain (-3.165 vs -2.373; P = .0005), but not in HAQ-DI (-0.523 vs -0.496; P = .5849).

在第12周时，DAS28-CRP ≤3.2的反应率在使用upadacitinib治疗的患者中（43.3%）优于使用adalimumab治疗的患者（22.4%；差异，21.0% [95% 置信区间: 12.9-29.1]；P < .0001），ACR50（38.2% vs 26.8% [P = .0068]）、DAS28-CRP <2.6（28.4% vs 14.5%；P = .0002）、DAS28-CRP平均变化（-2.432 vs -1.840；P < .0001）和疼痛平均变化（-3.165 vs -2.373；P = .0005）也是如此，但在HAQ-DI（-0.523 vs -0.496；P = .5849）上没有显著差异。

Safety was comparable between treatments.

两种治疗的安全性相当。

Conclusions

The primary endpoint of the SELECT-SWITCH trial was met, with a higher percentage of patients with active RA who switched to upadacitinib after first TNFi failure achieving DAS28-CRP ≤3.2 at 12 weeks than those cycling to a second TNFi, adalimumab, with generally similar safety profiles.

SELECT-SWITCH试验的主要终点已经达成，与那些在首次TNFi失败后转用阿达木单抗的患者相比，更多的活跃类风湿关节炎患者在首次TNFi失败后转用upadacitinib治疗，并在12周内达到DAS28-CRP ≤3.2，且安全性概况大致相似。

gov_identifier

NCT05814627.

NCT05814627。