Leveraging the Accelerating Medicines Partnership (AMP) Lupus Nephritis (LN) dataset, we evaluated longitudinal patterns, rates, and predictors of response to standard-of-care therapy in patients with lupus nephritis. Patients from US academic medical centers with class III, IV, and/or V LN and a baseline urine protein/creatinine (UPCR) ratio ≥ 1.0 (n = 180) were eligible for this analysis. Complete response (CR) required the following: (1) UPCR < 0.5; (2) normal serum creatinine (≤ 1.3 mg/dL) or, if abnormal, ≤ 125% of baseline; and (3) prednisone ≤ 10 mg/day. Partial response (PR) required the following: (1) > 50% reduction in UPCR; (2) normal serum creatinine or, if abnormal, ≤ 125% of baseline; and (3) prednisone dose ≤ 15 mg/day. Response rates to the standard of care at week 52 were CR = 22.2%; PR = 21.7%; non-responder (NR) = 41.7%, and not determined (ND) = 14.4%. Only 8/180 (4.4%) patients had a week 12 CR sustained through week 52. Eighteen (10%) patients attained a week 12 PR or CR and sustained their responses through week 52 and 47 (26.1%) patients achieved sustained PR or CR at weeks 26 and 52. Week 52 CR or PR attainment was associated with baseline UPCR > 3 (ORadj = 3.71 [95%CI = 1.34–10.24]; p = 0.012), > 25% decrease in UPCR from baseline to week 12 (ORadj = 2.61 [95%CI = 1.07–6.41]; p = 0.036), lower chronicity index (ORadj = 1.33 per unit decrease [95%CI = 1.10–1.62]; p = 0.003), and positive anti-dsDNA antibody (ORadj = 2.61 [95%CI = 0.93–7.33]; p = 0.069). CR and PR rates at week 52 were consistent with the standard-of-care response rates observed in prospective registrational LN trials. Low sustained response rates underscore the need for more efficacious therapies and highlight how critically important it is to understand the molecular pathways associated with response and non-response.

中文翻译：

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狼疮性肾炎标准护理治疗反应的纵向模式和预测因素：来自加速药物合作伙伴狼疮网络的数据

利用加速药物合作伙伴关系 (AMP) 狼疮性肾炎 (LN) 数据集，我们评估了狼疮性肾炎患者对标准治疗治疗的纵向模式、比率和预测因子。来自美国学术医疗中心的 III、IV 和/或 V 级 LN 且基线尿蛋白/肌酐 (UPCR) 比率 ≥ 1.0 (n = 180) 的患者符合本分析的资格。完全缓解 (CR) 要求满足以下条件： (1) UPCR < 0.5；(2) 血清肌酐正常（≤ 1.3 mg/dL），或者如果异常，≤ 基线的 125%；(3)泼尼松≤10毫克/天。部分缓解 (PR) 要求满足以下条件： (1) UPCR 降低 > 50%；(2) 血清肌酐正常，或者如果异常，≤基线的125%；(3)泼尼松剂量≤15毫克/天。第 52 周时对标准护理的反应率为 CR = 22.2%；公关率=21.7%；无反应者 (NR) = 41.7%，未确定者 (ND) = 14.4%。只有 8/180 (4.4%) 患者的第 12 周 CR 持续到第 52 周。十八 (10%) 患者在第 12 周达到 PR 或 CR，并在第 52 周持续缓解，47 (26.1%) 患者达到持续 PR 或第 26 周和第 52 周达到 CR。第 52 周达到 CR 或 PR 与基线 UPCR > 3 相关（ORadj = 3.71 [95%CI = 1.34–10.24]；p = 0.012），从基线到第 12 周 UPCR 下降 > 25% （ORadj = 2.61 [95%CI = 1.07–6.41]；p = 0.036），慢性指数较低（ORadj = 1.33 每单位减少 [95%CI = 1.10–1.62]；p = 0.003），抗 dsDNA 抗体呈阳性（ORadj = 2.61 [95%CI = 0.93–7.33]；p = 0.069）。第 52 周时的 CR 和 PR 率与前瞻性注册 LN 试验中观察到的标准治疗反应率一致。低持续缓解率强调需要更有效的治疗方法，并强调了解与缓解和无缓解相关的分子途径是多么重要。