Sun Fangfang, Wu Huaxiang, Wang Zitao, Wu Tong, Wu Xue, Chen Jie, Zhang Danting, Bao Chunde, Shen Nan, Wu Lijun, Zhu Jing, Ye Shuang
Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 201112, China.
Department of Rheumatology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310009, China.
Biomedicines. 2023 Mar 21;11(3):962. doi: 10.3390/biomedicines11030962.
: The effectiveness and safety of belimumab in Chinese lupus patients with different disease activities were investigated in a real-world setting. : Patients who received 10 mg/kg belimumab intravenously on weeks 0, 2, and 4, and then every 4 weeks on a background of standard-of-care (SoC) therapy and had a follow-up of more than 6 months were enrolled from four centers in China. They were stratified according to the Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score at baseline as the moderate/severe (SELENA-SLEDAI > 6) or mild subgroups (SELENA-SLEDAI ≤ 6). Attainment of the Lupus Low Disease Activity State (LLDAS) or remission on treatment was analyzed in all patients. The SLE Responder Index 4 (SRI-4) and SELENA-SLEDAI Flare Index (SFI) were evaluated for patients with moderate/severe disease and mild disease, respectively. Patients in the control arm with SoC alone from previous metformin lupus trials were selected by propensity score matching (PSM) as the reference group. : 224 SLE patients with a mean follow-up of 11.7 months receiving belimumab were enrolled in this observational study, of which 126 and 98 were in the moderate/severe and mild subgroup, respectively. At 12 months, 54.76% of the patients attained LLDAS and 28.57% attained remission. Lower daily prednisone at baseline were independently associated with 12-month LLDAS. Further, 87% of the subgroup with moderate/severe disease achieved SRI-4 at 12 months and a high SLEDAI at baseline was its predictive factor. For the mild subgroup, a reduced flare rate was observed compared with PSM reference (17.5%, vs. 38.6%, = 0.021). Infection events, particularly viral infections and pneumonia were recorded in 7 and 6 patients, respectively. : Our real-world data supported the effectiveness and safety of belimumab in Chinese lupus patients.
在真实世界环境中研究了贝利尤单抗在中国不同疾病活动度狼疮患者中的有效性和安全性。在中国四个中心招募了患者，这些患者在第0、2和4周静脉注射10mg/kg贝利尤单抗，然后在标准治疗（SoC）背景下每4周注射一次，且随访时间超过6个月。根据基线时的《红斑狼疮国家评估 - 系统性红斑狼疮疾病活动指数》（SELENA - SLEDAI）评分将他们分为中度/重度（SELENA - SLEDAI > 6）或轻度亚组（SELENA - SLEDAI ≤ 6）。分析了所有患者治疗后达到狼疮低疾病活动状态（LLDAS）或缓解的情况。分别对中度/重度疾病和轻度疾病患者评估了系统性红斑狼疮缓解指数4（SRI - 4）和SELENA - SLEDAI复发指数（SFI）。通过倾向评分匹配（PSM）选择先前二甲双胍治疗狼疮试验中仅接受SoC的对照组患者作为参考组。
本观察性研究纳入了224例接受贝利尤单抗治疗且平均随访11.7个月的系统性红斑狼疮患者，其中126例和98例分别属于中度/重度和轻度亚组。在12个月时，54.76%的患者达到LLDAS，28.57%的患者达到缓解。基线时较低的每日泼尼松剂量与12个月时达到LLDAS独立相关。此外，中度/重度疾病亚组中87%的患者在12个月时达到SRI - 4，基线时高SLEDAI是其预测因素。对于轻度亚组，与PSM参考组相比，复发率降低（17.5%对38.6%，P = 0.021）。分别有7例和6例患者记录到感染事件，特别是病毒感染和肺炎。
我们的真实世界数据支持贝利尤单抗在中国狼疮患者中的有效性和安全性。
