Relapse, rebound, and psoriasis adverse events: An advisory group report

Relapse, rebound, and psoriasis adverse events: An advisory group report
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DOI:
10.1016/j.jaad.2005.10.029
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发表时间:
2006-04-01
影响因子:
13.8
通讯作者:
Toth, D
Toth, D
中科院分区:
医学1区
文献类型:
--
作者:
Carey, W;Glazer, S;Toth, D

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银屑病是一种慢性疾病,其严重程度在患者之间存在差异,并且在个体患者中随时间变化不可预测。在治疗过程中,银屑病可能会因感染、内分泌因素、低钙血症、药物、心理压力、皮肤创伤或其他因素而加重。停止治疗的患者可能会出现疾病复发或病情恶化(反跳)。美国国家银屑病基金会(NPF)提出了复发和反跳的标准化定义。依法利珠单抗是一种重组人源化免疫球蛋白G - 1单克隆抗体,被批准用于银屑病的治疗。在依法利珠单抗的临床试验中,一小部分患者经历了与银屑病相关的符合方案定义的不良事件。在NPF反跳定义公布之后,对依法利珠单抗临床试验数据进行了事后探索性分析。依法利珠单抗临床试验的研究者讨论了他们的观察结果、分析以及他们对正在接受或停止依法利珠单抗治疗的患者的个体治疗方法,其结论在此进行描述。
Psoriasis is a chronic disease, the severity of which varies among patients and changes unpredictability time in individual patients. Psoriasis can he exacerbated during treatment by infection, endocrine factors, hypocalcemia, medications, psychologic stress, skin trauma, or other factors. Patients who discontinue treatments may experience a return of disease-relapse-or worsening of disease-rebound. The National Psoriasis Foundation (NPF) proposed standardized definitions of relapse and rebound. Efalizumab, a recombinant humanized immunoglobin G-1 monoclonal antibody, is approved for the management of psoriasis. During efalizumab clinical trials, a small percentage of patients experienced protocol-defined adverse events related to psoriasis. After publication of the NPF definition of rebound, post hoc exploratory analyses of the efalizumab clinical trial data were performed. The efalizumab clinical trial investigators discussed their observations, the analyses, and their individual approaches to the treatment of patients receiving or discontinuing efalizumab therapy, the conclusions of which are described herein.