The effect of moderate-dose corticosteroids in preventing severe flares in patients with serologically active, but clinically stable, systemic lupus erythematosus - Findings of a prospective, randomized, double-blind, placebo-controlled trial
The effect of moderate-dose corticosteroids in preventing severe flares in patients with serologically active, but clinically stable, systemic lupus erythematosus - Findings of a prospective, randomized, double-blind, placebo-controlled trial
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DOI：
10.1002/art.22198
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发表时间：
2006-11-01
影响因子：
--
通讯作者：
Abramson, Steven B.
中科院分区：
文献类型：
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作者：
Tseng, Chung-E;Buyon, Jill P.;Abramson, Steven B.
Objective.抗双链DNA（抗dsDNA）和补体的系列测量在系统性红斑狼疮（SLE）的管理中是常规的，但它们作为生物标志物在预防复发的先发制人治疗中的效用仍然是一个有争议的话题。我们假设抗dsDNA和C3 a的同时升高可以预测稳定或非活动性疾病患者的SLE活动性，短期皮质类固醇治疗可以避免发作。在这项前瞻性、随机、双盲、安慰剂对照试验中，每月对154名患者进行评估，长达18个月，测量C3 a、C3、C4、CH 50和抗dsDNA水平。临床上保持稳定但显示SLE发作的血清学证据（在前1-2个月的随访中抗dsDNA水平升高25%和C3 a水平升高50%）的患者随机接受泼尼松或安慰剂治疗，剂量为30 mg/天持续2周，20 mg/天持续1周，10 mg/天持续1周。41例患者（21例随机分配至泼尼松组，20例随机分配至安慰剂组）发生血清学发作。分析40 mg/天和/或添加免疫抑制剂后发生的重度发作。此外，在开始泼尼松治疗后1个月，系统性红斑狼疮疾病活动指数评分改善，抗dsDNA抗体水平降低，C4水平升高。这些初步数据支持我们的假设，即在C3 a和抗dsDNA水平升高的临床稳定的SLE患者的子集中，短期皮质类固醇治疗可能避免严重发作。
Objective. Serial measurements of anti-doublestranded DNA (anti-dsDNA) and complement are routine in the management of systemic lupus erythematosus (SLE), but their utility as biomarkers in preemptive treatment to prevent flares remains a subject of controversy. We hypothesized that concomitant elevation of anti-dsDNA and C3a can predict SLE activity in patients with stable or inactive disease and that short-term treatment with corticosteroids can avert flares.Methods. In this prospective, randomized, double-blind, placebo-controlled trial, 154 patients were evaluated monthly for up to 18 months, with measurements of C3a, C3, C4, CH50, and anti-dsDNA levels. Patients who remained clinically stable but showed serologic evidence of an SLE flare (elevation of both the anti-dsDNA level by 25% and the C3a level by 50% over the previous 1-2 monthly visits) were randomized to receive either prednisone or placebo therapy at a dosage of 30 mg/day for 2 weeks, 20 mg/day for 1 week, and 10 mg/day for 1 week.Results. Forty-one patients (21 randomized to prednisone and 20 randomized to placebo) experienced a serologic flare. Analysis of severe flares occurring 40 mg/day and/or the addition of an immunosuppressive agent. Furthermore, improvement in scores on the Systemic Lupus Erythematosus Disease Activity Index, decreased levels of anti-dsDNA antibodies, and increased levels of C4 occurred 1 month after initiation of prednisone treatment.Conclusion. These preliminary data support our hypothesis that in a subset of clinically stable SLE patients with a combination of elevated C3a and anti-dsDNA levels, short-term corticosteroid therapy may avert a severe flare.