Effectiveness and safety of belimumab in patients with systemic lupus erythematosus in a real-world setting
Effectiveness and safety of belimumab in patients with systemic lupus erythematosus in a real-world setting
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DOI：
10.1080/03009742.2019.1603324
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发表时间：
2019-06-29
影响因子：
2.1
通讯作者：
Cervera, R.
中科院分区：
文献类型：
--
作者：
Anjo, C.;Mascaro, J-M, Jr.;Cervera, R.
目的：探讨贝利木单抗治疗活动性系统性红斑狼疮（SLE）的有效性和安全性。研究方法：对巴塞罗那医院门诊自身免疫疾病科接受贝利木单抗治疗的所有SLE患者进行了回顾性分析。在基线和6、12和24个月时记录系统性红斑狼疮疾病活动指数2000（SLEDAI-2K）评分、临床SLEDAI-2K、抗双链DNA（抗dsDNA）抗体水平、补体成分C3和C4以及50%溶血性补体活性（CH 50）。还收集了不良事件。结果：23例患者（100%女性）入组研究。导致贝利木单抗使用的最常见表现是关节炎（91%）和皮肤受累（39%）。SLEDAI-2K和临床SLEDAI-2K在所有时间点均随时间改善（p < 0.005）。治疗期间补体水平升高，抗dsDNA抗体值下降。泼尼松的平均剂量在所有时间点都可以逐渐减少，并在24个月时达到最大和显著减少（10.4 +/- 4.8 mg/天至4.8 +/- 2.1 mg/天; p < 0.0005）。贝利木单抗的耐受性良好，只有6名患者（26%）发生了不良事件，所有这些事件都被归类为感染（1例尿路感染，尿培养中未检出细菌，5例病毒感染）。未观察到死亡、重度输注反应或超敏反应。结论：在我们的SLE患者中，贝利木单抗降低了疾病活动性，并允许逐渐减少糖皮质激素的每日剂量，具有良好的安全性。
Objective: To investigate the effectiveness and safety of belimumab in patients with active systemic lupus erythematosus (SLE) in a real-life setting. Methods: All SLE patients treated with belimumab in the Department of Autoimmune Diseases of the Hospital Clinic of Barcelona were retrospectively analysed. The Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, clinical SLEDAI-2K, levels of anti-double-stranded DNA (anti-dsDNA) antibody, complement components C3 and C4, and 50% haemolytic complement activity (CH50) were recorded at baseline and at 6, 12, and 24 months. Adverse events were also collected. Results: Twenty-three patients (100% women) were enrolled in the study. The most frequent manifestations that led to belimumab use were arthritis (91%) and skin involvement (39%). Both SLEDAI-2K and clinical SLEDAI-2K improved over time at all time-points (p < 0.005). Complement levels increased and the values of anti-dsDNA antibody decreased during treatment. The mean dose of prednisone could be tapered at all time-points and achieved maximum and significant reduction at 24 months (10.4 +/- 4.8 mg/day to 4.8 +/- 2.1 mg/day; p < 0.0005). Belimumab was well tolerated and only six patients (26%) experienced adverse events, all of which were classified as infections (one urinary tract infection without bacterial detection in urine culture and five viral infections). No deaths, severe infusion reactions, or hypersensitivity reactions were noted. Conclusion: In our patients with SLE, belimumab decreased disease activity and allowed tapering of the daily glucocorticoid dose with a good safety profile.