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阿尼鲁单抗治疗难治性皮肤红斑狼疮。

Anifrolumab for treatment of refractory cutaneous lupus erythematosus.

机构信息

Department of Dermatology, UNC Chapel Hill School of Medicine, Chapel Hill, NC, USA.

出版信息

Clin Exp Dermatol. 2022 Nov;47(11):1998-2001. doi: 10.1111/ced.15335. Epub 2022 Aug 26.

Abstract

Cutaneous lupus erythematosus (CLE) is a spectrum of skin changes related to systemic lupus erythematosus (SLE), a family of autoimmunity manifesting characteristic multisystem inflammation and damage. Treatment of CLE continues to evolve, especially for patients with moderate to severe disease. Type 1 interferon (IFN-1) plays a significant role in CLE pathogenesis. Anifrolumab, a fully humanized monoclonal antibody, selectively binds and inhibits the IFN-α receptor 1. Evidence from multiple Phase II and III randomized trials resulted in approval for anifrolumab for treatment of moderate to severe SLE. We present a case series of three patients with refractory CLE significantly improved with anifrolumab. The patients were recruited via clinic interaction and treated with anifrolumab from January 2021 to April 2022. Each patient received at least 12 weeks of therapy. Treatment and follow-up is ongoing. Patients were eligible for the study if they were a patient of the UNC Hospital System with resistant CLE, defined as having received inadequate disease control with standard therapies, including antimalarials, disease-modifying agents and biologics. Outcome measures were improvement in patient-reported symptoms and physician observation of erythema and pigmentary changes. All cases demonstrated significant improvement in disease appearance, cutaneous involvement, and symptomology after treatment with 2 months of anifrolumab infusions. Anifrolumab shows great potential for improving CLE in patients who have failed standard of care and multiple treatment options, including those that have failed belimumab or those who smoke. This report highlights the value of anifrolumab in managing patients with refractory CLE.

摘要

皮肤红斑狼疮(CLE)是与系统性红斑狼疮(SLE)相关的一系列皮肤变化,SLE 是一组自身免疫性疾病,表现为特征性多系统炎症和损伤。CLE 的治疗方法仍在不断发展,尤其是对于中重度疾病患者。I 型干扰素(IFN-1)在 CLE 的发病机制中起着重要作用。阿尼鲁单抗是一种完全人源化的单克隆抗体,可选择性结合并抑制 IFN-α受体 1。来自多项 II 期和 III 期随机试验的证据导致阿尼鲁单抗被批准用于治疗中重度 SLE。我们报告了三例难治性 CLE 患者的病例系列,这些患者在接受阿尼鲁单抗治疗后显著改善。这些患者是通过诊所互动招募的,并在 2021 年 1 月至 2022 年 4 月期间接受阿尼鲁单抗治疗。每位患者至少接受了 12 周的治疗。治疗和随访仍在进行中。如果 UNC 医院系统的患者有难治性 CLE,定义为对标准治疗(包括抗疟药、疾病修正剂和生物制剂)控制不佳,则符合该研究的条件。评估标准是患者报告的症状和医生观察到的红斑和色素沉着变化的改善。在接受阿尼鲁单抗治疗 2 个月后,所有病例的疾病外观、皮肤受累和症状均显著改善。阿尼鲁单抗在改善对标准治疗和多种治疗方案(包括对贝利木单抗治疗无效或吸烟的患者)失败的患者的 CLE 方面具有巨大潜力。本报告强调了阿尼鲁单抗在管理难治性 CLE 患者中的价值。

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