Abstract：
OBJECTIVE: Discontinuation or continuation of maintenance immunosuppressive therapy (MIST) after a severe lupus nephritis (LN) requires measuring the risk of relapse but reliable clinical and biological markers are lacking. The WIN-IgE study assesses the value of serum anti-dsDNA IgE autoantibodies as a biomarker for the prediction of relapse in severe LN.
METHODS: WIN-IgE is an ancillary study of the WIN-Lupus study (NCT01284725), a prospective controlled clinical trial which evaluated the discontinuation of MIST after 2-3 years in class III or IV±V LN with active lesions. WIN-IgE included all patients with available serum collected at randomisation for continuation or discontinuation of MIST. In these sera, anti-dsDNA antibodies, IgE and IgG, were quantified by ELISA and compared between patients who experienced LN relapse and those who did not during the 24 months of follow-up.
RESULTS: 52 patients were included, 25 in the MIST continuation group and 27 in the MIST discontinuation group, 12 experienced a biopsy-proven relapse of LN. Initial anti-dsDNA IgE antibodies levels were higher in patients with subsequent LN relapse. Anti-dsDNA IgG was not associated with relapse. Survival without LN relapse was lower in patients with anti-dsDNA IgE levels above vs below a threshold of 1.9 arbitrary units (p=0.019), particularly in the subgroup of patients randomised to discontinue MIST (p=0.002). In all patients, anti-dsDNA IgE above 1.9 arbitrary units had a positive predictive value of 0.8 for severe LN relapse.
CONCLUSIONS: These results suggest blood anti-dsDNA IgE as a non-invasive predictive marker of LN relapse.
METHODS: WIN-IgE is an ancillary study of the WIN-Lupus study (NCT01284725), a prospective controlled clinical trial which evaluated the discontinuation of MIST after 2-3 years in class III or IV±V LN with active lesions. WIN-IgE included all patients with available serum collected at randomisation for continuation or discontinuation of MIST. In these sera, anti-dsDNA antibodies, IgE and IgG, were quantified by ELISA and compared between patients who experienced LN relapse and those who did not during the 24 months of follow-up.
RESULTS: 52 patients were included, 25 in the MIST continuation group and 27 in the MIST discontinuation group, 12 experienced a biopsy-proven relapse of LN. Initial anti-dsDNA IgE antibodies levels were higher in patients with subsequent LN relapse. Anti-dsDNA IgG was not associated with relapse. Survival without LN relapse was lower in patients with anti-dsDNA IgE levels above vs below a threshold of 1.9 arbitrary units (p=0.019), particularly in the subgroup of patients randomised to discontinue MIST (p=0.002). In all patients, anti-dsDNA IgE above 1.9 arbitrary units had a positive predictive value of 0.8 for severe LN relapse.
CONCLUSIONS: These results suggest blood anti-dsDNA IgE as a non-invasive predictive marker of LN relapse.
摘要：
目的：重度狼疮性肾炎（LN）后停止或继续维持免疫抑制治疗（MIST）需要测量复发风险，但缺乏可靠的临床和生物学标志物。WIN-IgE研究评估血清抗dsDNAIgE自身抗体作为预测严重LN复发的生物标志物的价值。
方法：WIN-IgE是WIN-Lupus研究的辅助研究（NCT01284725），一项前瞻性对照临床试验，该试验评估了有活动性病变的III级或IV±V级LN在2-3年后停用MIST的情况。WIN-IgE包括在随机分组时收集的所有患者，用于继续或停止MIST。在这些血清中，抗dsDNA抗体，IgE和IgG，通过ELISA定量，并在24个月随访期间发生LN复发的患者和未发生LN复发的患者之间进行比较。
结果：纳入52例患者，MIST延续组25人，MIST停药组27人，12经历了活检证实的LN复发。在随后的LN复发的患者中，初始抗dsDNAIgE抗体水平较高。抗dsDNAIgG与复发无关。在抗dsDNAIgE水平高于和低于阈值1.9任意单位的患者中，无LN复发的生存率较低（p=0.019），特别是在随机停止MIST的患者亚组(p=0.002).在所有患者中，抗dsDNAIgE高于1.9任意单位对严重LN复发的阳性预测值为0.8.
结论：这些结果表明血液抗dsDNAIgE是LN复发的非侵入性预测标志物。
方法：WIN-IgE是WIN-Lupus研究的辅助研究（NCT01284725），一项前瞻性对照临床试验，该试验评估了有活动性病变的III级或IV±V级LN在2-3年后停用MIST的情况。WIN-IgE包括在随机分组时收集的所有患者，用于继续或停止MIST。在这些血清中，抗dsDNA抗体，IgE和IgG，通过ELISA定量，并在24个月随访期间发生LN复发的患者和未发生LN复发的患者之间进行比较。
结果：纳入52例患者，MIST延续组25人，MIST停药组27人，12经历了活检证实的LN复发。在随后的LN复发的患者中，初始抗dsDNAIgE抗体水平较高。抗dsDNAIgG与复发无关。在抗dsDNAIgE水平高于和低于阈值1.9任意单位的患者中，无LN复发的生存率较低（p=0.019），特别是在随机停止MIST的患者亚组(p=0.002).在所有患者中，抗dsDNAIgE高于1.9任意单位对严重LN复发的阳性预测值为0.8.
结论：这些结果表明血液抗dsDNAIgE是LN复发的非侵入性预测标志物。
