Clinical Efficacy of Routinely Administered Belimumab on Proteinuria and Neuropsychiatric Lupus
Clinical Efficacy of Routinely Administered Belimumab on Proteinuria and Neuropsychiatric Lupus
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DOI：
10.3389/fmed.2020.00222
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发表时间：
2020-05-27
影响因子：
3.9
通讯作者：
Korsten, Peter
中科院分区：
文献类型：
--
作者：
Pluess, Marlene;Tampe, Bjoern;Korsten, Peter
背景和目的：贝利木单抗（BEL）是一种单克隆抗体，被批准用于治疗活动性系统性红斑狼疮（SLE），但不用于狼疮性肾炎（LN）和神经精神性系统性红斑狼疮（NPSLE）。我们的目的是评估BEL对这些严重的，可能危及生命的表现的影响。方法：回顾性观察性队列研究，使用常规临床资料，在一个病例系列的SLE患者接受BEL。结果：16例活动期SLE患者接受BEL治疗。9例因无LN或NPSLE而被排除。LN 6例，NPSLE 1例。所有LN患者接受BEL除了标准治疗，包括糖皮质激素，羟氯喹，霉酚酸酯在5例，他克莫司在1例。3例蛋白尿> 1，000 mg/g肌酐的患者反应良好（1例完全肾反应，2例部分肾反应）;所有其他患者的蛋白尿减少，抗dsDNA水平降低。既往治疗失败的NPSLE患者皮肤和神经精神症状持续临床改善。有1例轻度过敏反应和1例下呼吸道感染，但无其他不良事件。1例患者因临床症状无改善而停止治疗，另1例患者因临床缓解而停止治疗。结论：在我们的系列研究中，尽管进行了标准治疗，但BEL仍导致蛋白尿超过1，000 mg/g肌酐的患者的蛋白尿减少，并导致1例NPSLE患者的临床显著改善。未观察到不良事件。贝伐他汀给药的BEL显示出对非批准表现的临床疗效，但需要仔细选择患者。
Background and Objectives:Belimumab (BEL) is a monoclonal antibody approved for the treatment of active systemic lupus erythematosus (SLE) but not for lupus nephritis (LN) and neuropsychiatric systemic lupus erythematosus (NPSLE). We aimed to assess BEL's effects on these severe, potentially life-threatening manifestations. Methods:Retrospective observational cohort study using routine clinical data in a case series of patients with SLE receiving BEL. Results:Sixteen patients received BEL therapy for active SLE. Nine were excluded because they had no LN or NPSLE. Six suffered from LN, and one patient had NPSLE. All LN patients received BEL in addition to standard therapy including glucocorticoids, hydroxychloroquine, and mycophenolate mofetil in five cases, and tacrolimus in one case. Three patients with proteinuria >1,000 mg/g creatinine responded well (one complete, two partial renal responses); all other patients had decreasing proteinuria and a reduction in anti-dsDNA levels. The patient with NPSLE who had failed previous therapies had persistent clinical improvement of cutaneous and neuropsychiatric manifestations. There was one mild allergic reaction and one lower respiratory tract infection, but no other adverse events. One patient discontinued therapy due to a lack of improvement in clinical symptoms, another because of clinical remission. Conclusions:In our series, BEL led to a decrease of proteinuria in patients with proteinuria of more than 1,000 mg/g creatinine despite standard of care treatment, and led to a marked clinical improvement in one patient with NPSLE. No adverse events were observed. Routinely administered BEL shows clinical efficacy on non-approved manifestations, but careful patient selection is warranted.