Low-dose belimumab reduced risk of flares in patients with systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled trial.

Methods

In this 52-week, randomised, placebo-controlledtrial, patients who had a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of ≤6, with no A and ≤ 1 B on British Isles Lupus Assessment Group, and who had prednisone ≤20 mg/d at screening were enrolled and randomly assigned 1:1 to intravenous 120 mg belimumab or placebo (saline).

在这项为期52周的随机、安慰剂对照试验中，入组并随机分配1:1接受静脉注射120 mg贝利木单抗或安慰剂（生理盐水）的患者为：SELENA-SLEDAI评分为≤6，英国狼疮评估小组评分中无A级且≤1 B级，且筛选时泼尼松≤20 mg/d的患者。

The primary outcome was disease flares within 52 weeks.

主要结果是52周内的疾病发作。

The trial was terminated prematurely on 10 April 2022 when Renji Hospital was designated as a COVID-19 referral centre during the Shanghai lockdown.

该试验于2022年4月10日被提前终止，当时仁济医院在上海封锁期间被指定为COVID-19转诊中心。

Results

Overall, 90.5% and 86.1% of patients in the belimumab (n = 116) and placebo (n = 115) arms completed the study within a follow-up of 31 ± 16.1 weeks.

总体而言，在平均随访31±16.1周内，接受贝利木单抗治疗的患者(n = 116)和接受安慰剂治疗的患者(n = 115)分别有90.5%和86.1%完成了研究。

The primary endpoint was met.

主要终点已达到。

In total, 7.8% of patients receiving low-dose belimumab had disease flares, significantly lower than that in the placebo group (19.1%) (P = .012; difference 11.3%; 95% CI 1.8%-20.9%).

在接受低剂量贝利木单抗治疗的患者中，有7.8%的患者出现疾病复发，显著低于安慰剂组的19.1%（P = .012；差异11.3%；95% 置信区间1.8%-20.9%）。

Kaplan-Meier curves also demonstrated lower cumulative flare rates in the belimumab arm (P = .011, Hazard Ratio(HR), 0.38; 95% CI 0.17-0.83).

Kaplan-Meier曲线也显示，在贝利木单抗组的累积复发率较低（P = .011，风险比（HR），0.38；95% 置信区间0.17-0.83）。

Glucocorticoid-sparing effects were comparable (Δprednisone from baseline, -1.55 ± 10.11 mg/d vs -0.91 ± 7.43 mg/d, P = .075).

糖皮质激素节省效果相当（基线时的泼尼松剂量变化，-1.55 ± 10.11 mg/d 对比 -0.91 ± 7.43 mg/d，P = .075）。

SELENA-SLEDAI was reduced by 0.62 ± 2.14 in the belimumab group; however, it increased by 0.12 ± 2.80 in the placebo group (P = .009).

SELENA-SLEDAI 在贝利木单抗组中减少了0.62 ± 2.14；然而，在安慰剂组中增加了0.12 ± 2.80（P = .009）。

Any adverse events were comparable (61.2% vs 64.3%).

两组中任何不良事件的发生率相当（61.2% 对比 64.3%）。

Only 4 (3.4%) and 6 (5.2%) severe adverse events occurred in 2 groups, respectively.

仅在两组中分别发生了4例（3.4%）和6例（5.2%）严重不良事件。

Conclusions

Treatment with low-dose belimumab helped reduce the risks of disease flares in Chinese patients with systemic lupus erythematosus at low disease activity.

低剂量贝利木单抗治疗有助于降低中国低疾病活动度系统性红斑狼疮患者的疾病发作风险。

Belimumab was generally well-tolerated.

贝利木单抗通常耐受性良好。