Background: Biological agents (also termed biologics or biologicals) play a growingly central role in the treatment of immunological diseases. However, the numerous studies published on biologics complicate the decision on the most appropriate biologic for a given disease. We aim to address this problem by publishing a series of systematic reviews evaluating the safety and efficacy of B cell-targeting biologics for the treatment of immune-mediated diseases. This article assesses the safety and efficacy of atacicept, a recombinant fusion protein consisting of the binding portion of transmembrane activator and CAML interactor (TACI; also known as tumor necrosis factor receptor superfamily member 13B), which is able to bind the cytokines B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Objective: To evaluate atacicept's safety and efficacy for the treatment of immune-mediated disorders compared to placebo, conventional treatment or other biologics. Methods: The PRISMA checklist guided the reporting of the data. We searched the PubMed database between 4 October 2016 and 26 July 2018 concentrating on immune-mediated disorders. Results: The literature search identified 118 articles. After screening titles and abstracts against the inclusion and exclusion criteria and assessing full texts, ten articles were finally included in a narrative synthesis. Conclusions: Atacicept failed to show an effect in multiple sclerosis, optic neuritis, rheumatoid arthritis, and systemic lupus erythematosus. In patients with systemic lupus erythematosus, atacicept led to increased infection rates, but this adverse effect was not seen in the other treated diseases.

中文翻译：

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系统评价阿塔西普治疗免疫介导的疾病的安全性和有效性。

背景：生物制剂（也称为生物制剂或生物制剂）在免疫疾病的治疗中起着越来越重要的作用。但是，有关生物制剂的大量研究使针对特定疾病的最合适生物制剂的决策变得复杂。我们旨在通过发布一系列评估B细胞靶向生物制剂治疗免疫介导疾病的安全性和有效性的系统评价来解决这个问题。本文评估了atacicept（一种由跨膜激活剂和CAML相互作用物（TACI；也称为肿瘤坏死因子受体超家族成员13B）的结合部分组成的重组融合蛋白）的安全性和有效性，该蛋白能够结合细胞因子B细胞，活化因子（BAFF）和增殖诱导配体（APRIL）。目的：评估atacicept' 与安慰剂，常规治疗或其他生物制剂相比，其在治疗免疫介导的疾病方面的安全性和有效性。方法：PRISMA清单指导数据报告。我们在2016年10月4日至2018年7月26日期间搜索PubMed数据库，重点研究免疫介导的疾病。结果：文献检索发现118篇文章。在对照纳入和排除标准筛选标题和摘要并评估全文之后，最终在叙事综合中纳入了十篇文章。结论：Atacicept在多发性硬化症，视神经炎，类风湿性关节炎和系统性红斑狼疮中未显示出作用。在患有系统性红斑狼疮的患者中，atacicept导致感染率增加，但在其他治疗的疾病中未发现这种不良反应。