OBJECTIVES Iguratimod, a novel immunomodulatory agent for rheumatoid arthritis, has been shown to be effective against murine lupus. The aim of this study was to make a preliminary evaluation of the efficacy and safety of iguratimod as salvage therapy in patients with refractory lupus nephritis (LN). METHODS We enrolled eligible patients with refractory LN, which we defined as having failed or relapsed on at least two immunosuppressant agents. After enrollment, we substituted iguratimod (25 mg twice daily) for their previous immunosuppressant agents without increasing the dose of steroids. The primary outcome was complete/partial remission (PR/CR) at week 24. Patients who achieved remission continued iguratimod as maintenance therapy over an extended follow-up. RESULTS The study cohort comprised 14 patients with refractory LN, 10 of whom had recent treatment failure and 4 repeated relapses with inadequate initial responses. At enrollment, none of the patients had detectable evidence of extra-renal involvement. The median prednisone dosage was 10 mg/d (IQR 0-10 mg/day). Thirteen patients were eligible for response evaluation, with one patient missed. The renal response rate was 92.3% (12/13) at week 24, with 38.5% (5/13) achieving CR and 53.8% (7/13) achieving PR. We then continued to follow up the responding patients for up to 144 weeks. Twenty-five percent of the patients (3/12) had renal relapse after initial PR. The estimated glomerular filtration rate of all patients maintained stable during follow-up. One patient had a severe adverse reaction (anemia) but recovered fully after stopping iguratimod. CONCLUSIONS Our study supports the potential of iguratimod for treatment of refractory LN. Iguratimod could be a promising candidate drug for this condition.

中文翻译：

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伊古拉莫德作为难治性狼疮肾炎的替代诱导疗法：一项初步研究。

目的已证明类风湿关节炎的新型免疫调节剂伊古拉莫德可有效治疗鼠类狼疮。这项研究的目的是初步评估艾拉莫德作为难治性狼疮性肾炎（LN）患者的挽救疗法的疗效和安全性。方法我们招募了符合条件的难治性LN患者，我们将其定义为至少两种免疫抑制剂失败或复发。入组后，我们在不增加类固醇剂量的情况下，将伊古拉莫德（25 mg，每日两次）替代了其先前的免疫抑制剂。主要结果是在第24周时完全/部分缓解（PR / CR）。达到缓解的患者在延长的随访期内继续接受艾拉莫德作为维持治疗。结果该研究队列包括14例难治性LN患者，其中10例近期治疗失败，4例复发复发且初始反应不足。在入组时，没有患者有可检测到的肾外受累证据。泼尼松的中位剂量为10毫克/天（IQR 0-10毫克/天）。13名患者符合反应评估的条件，其中1名患者未参加。在第24周，肾反应率为92.3％（12/13），其中CR为38.5％（5/13），PR为53.8％（7/13）。然后，我们继续随访反应患者长达144周。初始PR后有25％（3/12）的患者出现肾脏复发。估计所有患者的肾小球滤过率在随访期间保持稳定。一名患者有严重的不良反应（贫血），但在停用艾拉莫德后完全康复。结论我们的研究支持艾拉莫德治疗难治性LN的潜力。伊古拉莫德可能是这种情况的有希望的候选药物。