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贝利尤单抗治疗系统性红斑狼疮的激素节省作用:真实世界观察性研究(BESST 研究)。

Belimumab corticosteroid-sparing treatment in systemic lupus erythematosus: a real-life observational study (BESST study).

机构信息

Department of Internal Medicine, Poitiers University Hospital, 2 Rue de La Milétrie, 86021, Poitiers Cedex, France.

University of Poitiers, Poitiers, France.

出版信息

Rheumatol Int. 2024 Nov;44(11):2465-2471. doi: 10.1007/s00296-024-05589-2. Epub 2024 Apr 30.

Abstract

Data about the impact of Belimumab on corticosteroid sparing in real life are scarce. To assess the corticosteroid-sparing effect among patients with systemic lupus erythematosus (SLE) treated with Belimumab in real-life settings. Multicentric observational retrospective study including patients with SLE and having received Belimumab for at least 6 months between 2011 and 2020, in eight French hospitals. "Low dose" referred to patients receiving up to 7.5 mg of prednisone a day and "Very low dose" to those receiving strictly ≤ 5 mg prednisone a day The primary endpoint was the reduction of daily prednisone dose after six months of Belimumab. The secondary endpoint was a change in the proportion of patients with low or very low dose of prednisone as well as those without prednisone during the Belimumab course. Censoring occurred for patients who stopped Belimumab. Bivariate analyses were performed using the Wilcoxon signed-rank test. The threshold for statistical significance was set at p < 0.05. Thirty patients were included. All were female with a median age of 38 years. A significant reduction in prednisone dose was observed at month 6 (10 [7-20] vs 6.75 [2-9] mg, p < 0.0001), continued until month 12 (10 [7-20] mg vs 5 [0-7.12] mg, p < 0.001) and was sustained until month 24. The proportion of patients with very low dose of prednisone and those without prednisone progressively increased during the Belimumab course. Introducing Belimumab in patients with SLE, in real-life conditions, is associated with early and sustained corticosteroid-sparing effect.

摘要

关于贝利尤单抗在真实世界中对皮质类固醇激素节省作用的数据很少。评估在真实环境中使用贝利尤单抗治疗系统性红斑狼疮(SLE)患者的皮质类固醇激素节省作用。这是一项包括 8 家法国医院的 2011 年至 2020 年间至少接受 6 个月贝利尤单抗治疗的 SLE 患者的多中心观察性回顾性研究。“低剂量”指的是每天接受≤7.5mg 泼尼松的患者,“非常低剂量”指的是每天严格接受≤5mg 泼尼松的患者。主要终点是在接受贝利尤单抗治疗 6 个月后泼尼松日剂量的减少。次要终点是在贝利尤单抗治疗期间,接受低剂量或非常低剂量泼尼松的患者比例以及无泼尼松患者比例的变化。对停止使用贝利尤单抗的患者进行了删失。使用 Wilcoxon 符号秩检验进行了双变量分析。统计显著性阈值设定为 p < 0.05。共纳入 30 例患者。所有患者均为女性,中位年龄为 38 岁。在第 6 个月观察到泼尼松剂量显著减少(10 [7-20] 与 6.75 [2-9] mg,p < 0.0001),持续到第 12 个月(10 [7-20] mg 与 5 [0-7.12] mg,p < 0.001),并持续到第 24 个月。在贝利尤单抗治疗期间,接受非常低剂量泼尼松和无泼尼松治疗的患者比例逐渐增加。在真实环境中引入贝利尤单抗治疗 SLE 患者与早期和持续的皮质类固醇激素节省作用相关。

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