Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Information Medicine, Big Data Research Center, Asan Medical Center, Seoul, Korea.
Korean J Intern Med. 2024 Mar;39(2):338-346. doi: 10.3904/kjim.2023.229. Epub 2023 Nov 30.
BACKGROUND/AIMS: Systemic lupus erythematosus (SLE) responder index (SRI)-4 response has been achieved with belimumab treatment in patients with moderate disease activity in cornerstone clinical trials and following studies. However, most studies involved patients treated with a mean prednisolone-equivalent dose of approximately 10 mg/d and focused on the steroid-sparing effect of belimumab. We aimed to identify the effect of belimumab in patients with mild-to-moderate SLE who were treated with low-dose or no corticosteroids.
We retrospectively reviewed the electronic medical records of patients treated with belimumab for at least 6 months between May 2021 and June 2022. The primary endpoint was SRI-4 response at 6 months.
Thirty-one patients were included (13 low dose- and 18 steroid non-users). The mean age was 39.2 ± 11.4 years, and 90.3% of patients were female. The baseline Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score was 6.0 (4.0-9.0). The primary endpoint was achieved in 32.3% (10/31) of patients. Significant improvements in anemia, C4 levels, and SELENA-SLEDAI score were observed during treatment. Univariate analysis showed that the baseline SELENA-SLEDAI and arthritis were significantly associated with SRI-4 response at 6 months, and only the SELENA-SLEDAI remained significant (p = 0.014) in multivariate analysis.
This cohort study is the first to report the efficacy of belimumab after minimizing the effect of corticosteroids. Belimumab showed efficacy in improving the SELENA-SLEDAI score, anemia, and low C4 in patients who did not receive corticosteroids or received only low doses.
背景/目的：在基石临床试验和后续研究中，贝鲁单抗治疗中度疾病活动的系统性红斑狼疮（SLE）患者达到了 SLE 应答指数（SRI）-4 应答。然而，大多数研究涉及的是接受平均约 10mg/d 等效泼尼松龙剂量治疗的患者，并且侧重于贝鲁单抗的类固醇节省效应。我们旨在确定在接受低剂量或无皮质类固醇治疗的轻度至中度 SLE 患者中贝鲁单抗的疗效。
我们回顾性地审查了 2021 年 5 月至 2022 年 6 月期间至少接受 6 个月贝鲁单抗治疗的患者的电子病历。主要终点是 6 个月时达到 SRI-4 应答。
共纳入 31 例患者（13 例接受低剂量治疗，18 例无激素使用者）。平均年龄为 39.2±11.4 岁，90.3%的患者为女性。基线安全性评估雌激素在狼疮中的应用-系统性红斑狼疮疾病活动指数（SELENA-SLEDAI）评分为 6.0（4.0-9.0）。主要终点在 32.3%（10/31）的患者中达到。在治疗过程中，贫血、C4 水平和 SELENA-SLEDAI 评分显著改善。单因素分析显示，基线 SELENA-SLEDAI 和关节炎与 6 个月时的 SRI-4 应答显著相关，且仅 SELENA-SLEDAI 在多因素分析中仍具有显著意义（p=0.014）。
本队列研究首次报告了在最小化皮质类固醇作用后贝鲁单抗的疗效。在未接受皮质类固醇或仅接受低剂量皮质类固醇治疗的患者中，贝鲁单抗显示出改善 SELENA-SLEDAI 评分、贫血和低 C4 的疗效。
