Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Mod Rheumatol. 2023 Jul 4;33(4):751-757. doi: 10.1093/mr/roac076.
To assess belimumab efficacy in patients from North East Asia (NEA) with systemic lupus erythematosus (SLE) in baseline demographic/disease characteristic subgroups.
This analysis of patient subgroups from BLISS-NEA (GSK Study 113750; NCT01345253) studied adults with SLE randomized to belimumab (10 mg/kg intravenous) or placebo. Primary endpoint, SLE Responder Index 4 (SRI-4) response rate at Week 52, was analysed in subgroups defined by gender, country, prednisone-equivalent dose, concomitant medications, Safety of Estrogens in Lupus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score, complement (C) levels, anti-double-stranded deoxyribonucleic acid (dsDNA) positivity, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index score.
Patients (overall population: N = 677; belimumab: n = 451, placebo: n = 226) were from China (76.4%), Korea (14.8%), and Japan (8.9%). The mean age was 32.1 years; 92.9% were female. In the overall population, more belimumab (53.8%) than placebo (40.1%) patients were SRI-4 Week 52 responders (p = .0001). SRI-4 response rates by subgroups were generally consistent with the overall population. A greater response with belimumab was seen in patients with a baseline SELENA-SLEDAI score ≥10 versus ≤9 and patients with low C3/C4 levels and anti-dsDNA positive at baseline versus those 'NOT' (low C3 and/or C4 and anti-dsDNA positive).
These findings continue to support the efficacy of belimumab in SLE.
评估贝利尤单抗在基线人口统计学/疾病特征亚组中来自东北亚（NEA）的系统性红斑狼疮（SLE）患者中的疗效。
这项对 BLISS-NEA 患者亚组的分析（GSK 研究 113750；NCT01345253）纳入了随机分配至贝利尤单抗（10mg/kg 静脉注射）或安慰剂的成人 SLE 患者。主要终点为第 52 周时 SLE 反应指数 4（SRI-4）应答率，根据性别、国家、泼尼松等效剂量、合并用药、狼疮评估的雌激素安全性-狼疮疾病活动指数（SELENA-SLEDAI）评分、补体（C）水平、抗双链 DNA（dsDNA）阳性、系统性红斑狼疮国际合作临床/美国风湿病学会损伤指数评分对亚组进行定义。
患者（总体人群：N=677；贝利尤单抗：n=451，安慰剂：n=226）来自中国（76.4%）、韩国（14.8%）和日本（8.9%）。平均年龄为 32.1 岁；92.9%为女性。在总体人群中，更多的贝利尤单抗（53.8%）患者比安慰剂（40.1%）患者达到 SRI-4 第 52 周应答（p=0.0001）。各亚组的 SRI-4 应答率与总体人群基本一致。与基线 SELENA-SLEDAI 评分≤9 的患者相比，基线 SELENA-SLEDAI 评分≥10 的患者以及基线时 C3/C4 水平低且抗 dsDNA 阳性的患者对贝利尤单抗的应答更好。
这些发现持续支持贝利尤单抗在 SLE 中的疗效。
