Cingireddy Ananya Reddy, Ramini Navya, Cingireddy Anirudh Reddy
Internal Medicine, Mountain View Regional Medical Center, Las Cruces, USA.
Anesthesiology and Critical Care, All India Institute of Medical Sciences, Raipur, IND.
Cureus. 2024 Jul 6;16(7):e63966. doi: 10.7759/cureus.63966. eCollection 2024 Jul.
Systemic lupus erythematosus (SLE) is an autoimmune disease, which poses significant challenges due to its chronic nature and complex clinical manifestations. For patients with moderate-to-severe SLE, anifrolumab, a monoclonal antibody that targets the type 1 interferon receptor (IFNAR), has emerged as a cutting-edge treatment option that can reduce disease activity, prevent organ damage from the illness or side effects resulting from medications, and enhance the quality of life for those living with SLE. Consequently, this drug has received approval from major regulatory agencies. Anifrolumab's safety, effectiveness, and long-term results are assessed in this systematic review using information from clinical trials, real-world research, and retrospective analysis. In particular, clinical investigations, such as the MUSE Phase II and TULIP Phase III trials, showed that anifrolumab significantly improved important outcomes compared to placebo, including the SLE Responder Index, major clinical response, and disease activity ratings. During extended use, anifrolumab demonstrated significant sustained efficacy and a tolerable safety profile, with controllable side events mostly associated with viral infections. Moreover, subgroup analyses, demonstrating that Asian patients and individuals with a strong interferon gene profile are particularly responsive to anifrolumab, underscore the importance of customized treatment methods. Anifrolumab's safety and effectiveness were further validated by real-world data, particularly in patients who reached the Lupus Low Disease Activity State (LLDAS), where the drug decreased glucocorticoid consumption and disease activity. Overall, anifrolumab shows great promise as a treatment for moderate-to-severe SLE, providing significant efficacy together with a manageable safety profile. To fully explore its therapeutic potential and optimize therapy approaches for the management of SLE, further research is necessary, especially in lupus nephritis and other disease subsets.
系统性红斑狼疮（SLE）是一种自身免疫性疾病，因其慢性病程和复杂的临床表现而带来重大挑战。对于中重度SLE患者，阿尼鲁单抗是一种靶向1型干扰素受体（IFNAR）的单克隆抗体，已成为一种前沿治疗选择，可降低疾病活动度，预防疾病导致的器官损害或药物副作用，并提高SLE患者的生活质量。因此，该药物已获得主要监管机构的批准。本系统评价利用来自临床试验、真实世界研究和回顾性分析的信息，评估了阿尼鲁单抗的安全性、有效性和长期结果。特别是，MUSE II期和TULIP III期试验等临床研究表明，与安慰剂相比，阿尼鲁单抗显著改善了重要结局，包括SLE缓解指数、主要临床反应和疾病活动评分。在长期使用过程中，阿尼鲁单抗显示出显著的持续疗效和可耐受的安全性，可控的副作用大多与病毒感染有关。此外，亚组分析表明，亚洲患者和干扰素基因谱较强的个体对阿尼鲁单抗特别敏感，这凸显了定制治疗方法的重要性。真实世界数据进一步验证了阿尼鲁单抗的安全性和有效性，特别是在达到狼疮低疾病活动状态（LLDAS）的患者中，该药物降低了糖皮质激素的用量和疾病活动度。总体而言，阿尼鲁单抗作为中重度SLE的治疗药物显示出巨大的前景，具有显著的疗效和可控的安全性。为了充分探索其治疗潜力并优化SLE的治疗方法，有必要进行进一步的研究，特别是在狼疮性肾炎和其他疾病亚组方面。
