The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
RMD Open. 2023 Aug;9(3). doi: 10.1136/rmdopen-2023-003270.
Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease characterised by unpredictable flares. Many patients with SLE are unable to achieve the recommended treatment goal of remission or the intermediate, yet still clinically beneficial, goal of Lupus Low Disease Activity State (LLDAS) with standard of care (SoC) treatments. LLDAS is an emerging treat-to-target goal in SLE with the aim of reducing organ damage and mortality. A high unmet need remains in SLE and mainstay glucocorticoid treatment is associated with unacceptable toxicity. The recently approved type I interferon receptor antagonist anifrolumab is a new treatment option for this historically underserved patient population. In phase 3 trials, a higher percentage of patients on anifrolumab achieved remission, as defined by the Definition Of Remission In SLE (DORIS), and LLDAS compared with placebo. Real-world clinical experience with anifrolumab use is still limited. Until real-world study results and updated treatment guidelines are available, personal expert clinical experience supported by data may inform clinical decision-making. This viewpoint article discusses four example patient types that could be considered for anifrolumab treatment based on (1) high-risk features early in the disease course, (2) inability to achieve and (3) maintain at least LLDAS, or (4) a desire to reduce or stop SoC. These patients with high unmet need may benefit from the addition of anifrolumab to SoC to achieve or maintain the therapeutic goals of LLDAS or DORIS remission.
系统性红斑狼疮（SLE）是一种异质性自身免疫性疾病，其特征为不可预测的发作。许多 SLE 患者无法通过标准治疗（SoC）达到推荐的缓解治疗目标或中间但仍具有临床获益的狼疮低疾病活动状态（LLDAS）目标。LLDAS 是 SLE 中的一个新兴治疗目标，旨在减少器官损伤和死亡率。SLE 仍存在高度未满足的需求，而糖皮质激素的主要治疗方法存在不可接受的毒性。最近批准的 I 型干扰素受体拮抗剂 anifrolumab 是这种历史上服务不足的患者群体的新治疗选择。在 3 期试验中，与安慰剂相比，更多接受 anifrolumab 治疗的患者达到了缓解的定义（DORIS）和 LLDAS，这是缓解的定义。然而，anifrolumab 的实际临床应用经验仍然有限。在真实世界的研究结果和更新的治疗指南可用之前，基于数据的个人专家临床经验可能会为临床决策提供信息。本文观点讨论了四种可能考虑使用 anifrolumab 治疗的示例患者类型，基于（1）疾病早期的高风险特征，（2）无法达到和/或（3）维持至少 LLDAS，或（4）减少或停止 SoC 的愿望。这些高未满足需求的患者可能受益于将 anifrolumab 添加到 SoC 中，以达到或维持 LLDAS 或 DORIS 缓解的治疗目标。
