The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan.
Rheumatology (Oxford). 2022 Aug 30;61(9):3614-3626. doi: 10.1093/rheumatology/keab953.
The efficacy of belimumab (BEL) during maintenance therapy in patients with SLE remains unclear in the real-life clinical setting. This study investigated the efficacy and safety of BEL in patients with SLE during maintenance therapy.
In this retrospective observational study, maintenance therapy was defined as low-dose glucocorticoid (GC) therapy (prednisolone equivalent dose of ≤0.2 mg/kg/day) in patients with a Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score <10. Participants comprised patients with SLE on HCQ or MMF [standard-of-care (SoC) group: n = 103] and those on BEL plus SoC (BEL+SoC group: n = 100). Selection bias was minimized using propensity score-based inverse probability of treatment weighting (IPTW). GC dose trajectories were modelled using growth mixture modelling (GMM). The primary end point was GC dose at 52 weeks.
No significant difference was observed in patient characteristics between the two groups after IPTW adjustment. The BEL+SoC group exhibited a significant decrease in GC dose. GC dose at 52 weeks and relapse rate were significantly lower in the BEL+SoC group than in the SoC group. The proportion of patients in one of four groups defined by GMM for which GC dose was tapered to 0 mg within 52 weeks (GC tapering-discontinuation group) was significantly higher in the BEL+SoC group than in the SoC group. In the BEL+SoC group, low SELENA-SLEDAI score and low GC dose at baseline were associated with being GC dose-tapering discontinuation.
The present study suggests that BEL is suitable for patients with SLE during maintenance therapy.
在真实临床环境中，贝鲁单抗（BEL）在狼疮维持治疗中的疗效尚不清楚。本研究旨在探讨 BEL 在狼疮维持治疗中的疗效和安全性。
在这项回顾性观察性研究中，维持治疗被定义为低剂量糖皮质激素（GC）治疗（泼尼松龙等效剂量≤0.2mg/kg/天），患者的安全性雌激素在红斑狼疮中的评估-SLE 疾病活动指数（SELENA-SLEDAI）评分<10。参与者包括接受羟氯喹或吗替麦考酚酯（标准治疗（SoC）组：n=103）和 BEL 加 SoC（BEL+SoC 组：n=100）治疗的狼疮患者。采用倾向评分逆概率治疗加权（IPTW）最小化选择偏倚。使用增长混合建模（GMM）对 GC 剂量轨迹进行建模。主要终点为 52 周时的 GC 剂量。
经 IPTW 调整后，两组患者的特征无显著差异。BEL+SoC 组 GC 剂量显著降低。BEL+SoC 组的 GC 剂量在 52 周和复发率显著低于 SoC 组。在 GMM 定义的四个 GC 剂量逐渐减少到 0mg 组中，52 周内 GC 剂量逐渐减少到 0mg 的患者比例在 BEL+SoC 组明显高于 SoC 组。在 BEL+SoC 组中，低 SELENA-SLEDAI 评分和基线时低 GC 剂量与 GC 剂量逐渐减少停药相关。
本研究表明 BEL 适合狼疮患者维持治疗。
