Current state of evidence on 'off-label' therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland - a consensus report
Current state of evidence on 'off-label' therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland - a consensus report
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DOI：
10.1177/0961203311426569
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发表时间：
2012-04-01
期刊：
影响因子：
2.6
通讯作者：
Doerner, T.
中科院分区：
文献类型：
--
作者：
Aringer, M.;Burkhardt, H.;Doerner, T.
系统性红斑狼疮（SLE）是一种严重的、可能危及生命的疾病，由于其器官表现的异质性，通常代表着治疗上的挑战。只有糖皮质激素、氯喹和羟氯喹、硫唑嘌呤、环磷酰胺和最近贝利木单抗在德国、奥地利和瑞士被批准用于SLE治疗。对糖皮质激素的依赖和对批准的治疗剂的抗性以及实质性毒性是常见的。因此，治疗考虑因素将包括批准用于其他适应症的药物的“标签外”使用。在这个共识的方法，努力已进行划定的限制，目前的证据对SLE器官疾病的治疗方案，并同意共同的做法。这是基于通过严格的文献综述获得的最佳证据和作者自己在非常相似的医疗条件下获得的可用药物的经验。这份共识文件的准备包括一次初步会议，以商定核心议程，系统性文献综述，随后形成共识并确定证据水平，然后收集来自小组成员。除了总体原则外，专家组还关注主要SLE器官表现的治疗（狼疮肾炎、关节炎、肺病、神经精神和血液学表现，本共识报告旨在支持临床医生参与对标准治疗无反应的SLE难治性病程患者的护理，根据现有最佳证据确定日期。Lupus（2012）21，386-401.
Systemic lupus erythematosus (SLE) can be a severe and potentially life-threatening disease that often represents a therapeutic challenge because of its heterogeneous organ manifestations. Only glucocorticoids, chloroquine and hydroxychloroquine, azathioprine, cyclophosphamide and very recently belimumab have been approved for SLE therapy in Germany, Austria and Switzerland. Dependence on glucocorticoids and resistance to the approved therapeutic agents, as well as substantial toxicity, are frequent. Therefore, treatment considerations will include 'off-label' use of medication approved for other indications. In this consensus approach, an effort has been undertaken to delineate the limits of the current evidence on therapeutic options for SLE organ disease, and to agree on common practice. This has been based on the best available evidence obtained by a rigorous literature review and the authors' own experience with available drugs derived under very similar health care conditions.Preparation of this consensus document included an initial meeting to agree upon the core agenda, a systematic literature review with subsequent formulation of a consensus and determination of the evidence level followed by collecting the level of agreement from the panel members. In addition to overarching principles, the panel have focused on the treatment of major SLE organ manifestations (lupus nephritis, arthritis, lung disease, neuropsychiatric and haematological manifestations, antiphospholipid syndrome and serositis).This consensus report is intended to support clinicians involved in the care of patients with difficult courses of SLE not responding to standard therapies by providing up-to-date information on the best available evidence. Lupus (2012) 21, 386-401.