以依库珠单抗为附加疗法治疗难治性狼疮肾炎的疗效和安全性：一项初步研究。
Efficacy and safety of Iguratimod as an add-on therapy for refractory lupus nephritis: A preliminary investigational study.
机构信息
Department of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Nephrology and Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
出版信息
Front Immunol. 2023 Mar 8;14:1062919. doi: 10.3389/fimmu.2023.1062919. eCollection 2023.
OBJECTIVES
IGU (IGU), a novel immunomodulatory agent for rheumatoid arthritis, has been shown to be effective and safe as monotherapy in a small population with refractory lupus nephritis (LN). The aim of this prospective study was to evaluate the efficacy and safety of IGU as an add-on therapy in patients with refractory LN in the context of clinical practice.
METHODS
This is a single-arm observational study. We have enrolled LN patients since 2019 at Renji Hospital. All participants should have recurrent or refractory LN with at least one immunosuppressant (IS) and have a baseline urine protein/creatinine ratio (UPCR) >1.0. After enrollment, we added IGU (25 mg twice daily) to one of their previous immunosuppressants (IS) without increasing the dose of steroids. The primary outcome was the complete renal response (CRR) in the 6th month. UPCR decrease of over 50% was defined as partial response (PR). Extended follow-up was performed after the initial 6 months.
RESULTS
We enrolled 26 eligible participants. 11/26 patients had chronic kidney disease (CKD) stage 2/3 at the baseline. The IS combined with IGU included mycophenolate mofetil, tacrolimus, and cyclosporin A. No IS change was allowed. 80.7% of patients had baseline steroids less than 0.5mg/kg daily and there was no steroids escalation during the IGU treatment. The CRR rate was 42.3% (11/26) at month 6. With a median follow-up of 52 weeks (range: 23-116 weeks), the CRR rate at the last visit was 50% (13/26) and 73.1% (19/26) of patients had UPCR decrease of over 50%. Six patients withdrew, three for no response and three for renal flare after initial CRR. One patient had an estimated glomerular filtration rate worsening of over 20% and was classified as renal flare. Three mild to moderate adverse events were recorded.
CONCLUSIONS
Our investigation merits further investigation in IGU as a potentially tolerable component of combination therapy for refractory LN.
目的
IGU（IGU）是一种新型免疫调节药物，在一小部分难治性狼疮肾炎（LN）患者中作为单药治疗已显示出有效且安全。本研究的目的是评估 IGU 在临床实践中作为附加疗法在难治性 LN 患者中的疗效和安全性。
方法
这是一项单臂观察性研究。自 2019 年以来，我们一直在仁济医院招募 LN 患者。所有患者均应患有复发性或难治性 LN，至少接受过一种免疫抑制剂（IS）治疗，且基线尿蛋白/肌酐比值（UPCR）＞1.0。入组后，我们在不增加类固醇剂量的情况下，将 IGU（每日两次，每次 25mg）添加到他们之前的一种免疫抑制剂（IS）中。主要结局是第 6 个月的完全肾脏反应（CRR）。UPCR 下降超过 50%定义为部分反应（PR）。初始 6 个月后进行了扩展随访。
结果
我们共纳入了 26 名符合条件的患者。26 名患者中有 11 名（42.3%）基线时患有慢性肾脏病（CKD）2/3 期。联合使用 IGU 的 IS 包括霉酚酸酯、他克莫司和环孢素 A。不允许改变 IS。80.7%的患者基线时每日类固醇用量小于 0.5mg/kg，在 IGU 治疗期间未进行类固醇剂量增加。第 6 个月时的 CRR 率为 42.3%（11/26）。中位随访 52 周（范围：23-116 周），末次随访时的 CRR 率为 50%（13/26），73.1%（19/26）的患者 UPCR 下降超过 50%。6 名患者退出，3 名因无反应，3 名因初始 CRR 后出现肾闪回。1 名患者估算肾小球滤过率恶化超过 20%，被归类为肾闪回。记录了 3 例轻度至中度不良事件。
结论
我们的研究表明，IGU 作为难治性 LN 联合治疗中一种潜在可耐受的药物成分值得进一步研究。
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