A phase 2, randomised, placebo-controlled study of guselkumab in adults with new-onset or relapsing giant cell arteritis.

This randomised, double-blind, placebo-controlled, phase 2 study evaluated guselkumab vs placebo for the treatment of giant cell arteritis (GCA).

这项随机、双盲、安慰剂对照的2期研究评估了Guselkumab与安慰剂治疗巨细胞动脉炎（GCA）的效果。

Methods

Patients ≥50 years of age with new-onset or relapsing GCA were randomised 2:1 to guselkumab or placebo.

年龄≥50岁的新发或复发性巨细胞动脉炎患者按2:1的比例随机分配至guselkumab组或安慰剂组。

Both arms received background glucocorticoid (GC) therapy, with a protocol-defined taper through week 26.

两组均接受基础糖皮质激素（GC）治疗，通过第26周的协议定义的递减。

The primary endpoint was the proportion of patients achieving GC-free remission at week 28.

主要终点是第28周达到无胃肠道(GC)缓解的患者比例。

Results

Thirty-five patients were randomised to receive guselkumab and 18 to receive placebo.

有35名患者被随机分配接受古塞尔库单抗治疗，18名患者被分配接受安慰剂。

All patients were White, 70% were female, and the mean age was 71.5 years; 60% had new-onset and 40% had relapsing GCA.

所有患者均为白人，70%为女性，平均年龄为71.5岁；60%为新发巨细胞动脉炎（GCA），40%为复发性GCA。

At week 28, 40% (14/35) and 33% (6/18) of patients in the guselkumab and placebo groups, respectively, achieved GC-free remission (P = .64), whereas 31% (11/35) and 39% (7/18) had experienced a GCA flare or discontinued due to worsening GCA.

在第28周时，guselkumab组和安慰剂组分别有40%（14/35）和33%（6/18）的患者实现了无GC缓解（P = .64），而分别有31%（11/35）和39%（7/18）的患者经历了GCA发作或因GCA恶化而停药。

Median time to first GCA flare through week 28 was not estimable (NE) in the guselkumab group (90% CI: 27.7-NE) and 29.7 weeks (90% CI: 20.1-NE) in the placebo group (P = .64).

在第28周时，guselkumab组首次GCA发作的中位时间无法估计（NE）（90%置信区间：27.7-NE），而安慰剂组为29.7周（90%置信区间：20.1-NE）（P = .64）。

Through week 60, 97% (34/35) and 94% (17/18) of patients in the guselkumab and placebo groups, respectively, had adverse events (AEs); the most common AEs, aside from worsening of GCA (49% and 56%, respectively), were COVID-19 infection (23% and 28%) and headache (17% and 39%).

截至第60周，guselkumab组和安慰剂组分别有97%（34/35）和94%（17/18）的患者出现不良事件（AEs）；除GCA恶化（分别为49%和56%）外，最常见的不良事件是COVID-19感染（分别为23%和28%）和头痛（分别为17%和39%）。

Conclusions

The study's primary endpoint (GC-free remission) was not met; results do not support the use of guselkumab in the treatment of GCA.

该研究的主要终点（无巨细胞动脉炎缓解）未达成；结果不支持在巨细胞动脉炎（GCA）治疗中使用guselkumab。