Ruiz-Irastorza Guillermo, Marín-García Beatriz, Dueña-Bartolomé Luis, Paredes Ruiz Diana, Osorio Amaia, Lazaro Estibaliz
Autoimmune Diseases, Instituto de Investigación Sanitaria Biobizkaia, Barakaldo, Spain
Euskal Herriko Unibertsitatea, Medikuntza eta Erizaintza Fakultatea, Leioa, Spain.
Lupus Sci Med. 2025 May 26;12(1):e001562. doi: 10.1136/lupus-2025-001562.
To assess the efficacy and toxicity of the Lupus-Cruces Nephritis (LCN) protocol compared with standard of care (SOC) with cyclophosphamide (CYC) or mycophenolate in patients with lupus nephritis (LN) during an extended follow-up time up to 10 years.
Patients with biopsy-proven class III, IV or V LN treated with LCN were compared with SOC. Patients in the LCN were treated with a CYC plus repeated methylprednisolone pulse-based regimen. The achievement of complete renal response (CRR) and the progression to chronic kidney disease (CKD) were the two main outcomes. Glucocorticoid (GC)-related toxicity, major infections and damage accrual were also analysed. A propensity score (PS)-adjusted multivariate analysis was used to overcome the confounding-by-indication bias.
147 patients were included in this study (47 LCN and 100 SOC). CRR at 12 months was 85% vs 44%, respectively (p<0.001). Eventually, 96% patients in the LCN group achieved CRR vs 74% patients in the SOC (p=0.002). In the multivariate PS-adjusted Cox model, LCN patients were more likely to eventually achieve CRR (PS-adjusted HR 3.5, 95% CI 2.2 to 5.5, p<0.001). The risk of progression to CKD was lower in LCN patients (PS-adjusted HR 0.3, 95% CI 0.11 to 0.82, p=0.019). The risks of GC-induced toxicity, renal or GC-related damage accrual and major infections were also lower in the LCN group: adjusted HR 0.09, 95% CI 0.02 to 0.39; PS-adjusted HR 0.14, 95% CI 0.04 to 0.4; PS-adjusted HR 0.2, 95% CI 0.046 to 0.95; respectively.
This study confirms the LCN protocol as an effective and safe, in addition to widely available and affordable, regimen for the induction therapy of LN.
在长达10年的延长随访期内，评估狼疮 - 克鲁塞斯肾炎（LCN）方案与环磷酰胺（CYC）或霉酚酸酯标准治疗（SOC）相比，对狼疮性肾炎（LN）患者的疗效和毒性。
将接受LCN治疗的经活检证实为III、IV或V级LN患者与SOC进行比较。LCN组患者采用CYC加重复甲基强的松龙脉冲方案治疗。完全肾反应（CRR）的实现和进展为慢性肾脏病（CKD）是两个主要结局。还分析了糖皮质激素（GC）相关毒性、主要感染和损伤累积情况。采用倾向评分（PS）调整的多变量分析来克服指示性混杂偏倚。
本研究纳入了147例患者（47例LCN组和100例SOC组）。12个月时的CRR分别为85%和44%（p<0.001）。最终，LCN组96%的患者实现了CRR，而SOC组为74%（p = 0.002）。在多变量PS调整的Cox模型中，LCN组患者最终更有可能实现CRR（PS调整后的HR为3.5，95%CI为2.2至5.5，p<0.001）。LCN组患者进展为CKD的风险较低（PS调整后的HR为0.3，95%CI为0.11至0.82，p = 0.019）。LCN组GC诱导毒性、肾脏或GC相关损伤累积以及主要感染的风险也较低：调整后的HR为0.09，95%CI为0.02至0.39；PS调整后的HR为0.14，95%CI为0.04至0.4；PS调整后的HR为0.2，95%CI为0.046至0.95。
本研究证实LCN方案是一种有效、安全、广泛可用且负担得起的LN诱导治疗方案。
