Gomez Alvaro, Enman Yvonne, Parodis Ioannis
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Patient Relat Outcome Meas. 2023 Jan 19;14:1-13. doi: 10.2147/PROM.S369584. eCollection 2023.
Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease, characterised by a relapsing-remitting pattern of inflammatory activity, with each relapse contributing to irreversible end-organ damage with detrimental effects on patients' course, adding up to morbidity burden and shortening life-length. Along with several other demographic, socioeconomic, and life-style factors, high inflammatory activity and accrued organ damage have been coupled with adverse health-related quality of life (HRQoL) within physical, mental, and psychosocial aspects. The management of SLE has improved substantially during the last decades, owing to a technological explosion that has advanced drug development towards more targeted options. Being the first drug to be approved for SLE in more than half a century and the first in history biological agent for SLE, the introduction in 2011 of the monoclonal antibody belimumab that specifically binds to the soluble counterpart of B cell activating factor (BAFF) was a breakthrough in SLE drug development. The efficacy and favourable safety profile of belimumab has been demonstrated across several clinical trials and observational studies. Herein, we reviewed the literature and provide a summary on the effects of belimumab on SLE patients' HRQoL based on 23 studies. Belimumab has been shown to induce clinically important improvements in physical aspects of HRQoL and in fatigue, the latter being a common and major complaint within the SLE population. People with SLE overall benefit more from belimumab within physical compared with mental aspects of HRQoL. However, despite improvements of clinical and immunological features upon therapy with belimumab, HRQoL perception remains unsatisfactory for a substantial percentage of the patients. Finally, our review made apparent an urgent need for optimisation of the use of patient-reported outcome measures, both in research and clinical practice.
系统性红斑狼疮（SLE）是一种慢性自身免疫性疾病，其特征为炎症活动呈复发-缓解模式，每次复发都会导致不可逆的终末器官损害，对患者病程产生不利影响，累积发病负担并缩短寿命。除了其他一些人口统计学、社会经济和生活方式因素外，高炎症活动和累积的器官损害在身体、心理和社会心理方面都与不良的健康相关生活质量（HRQoL）相关。在过去几十年中，SLE的治疗有了显著改善，这得益于技术的飞速发展，推动了药物研发朝着更具针对性的方向发展。2011年引入的单克隆抗体贝利尤单抗是半个多世纪以来首个被批准用于SLE的药物，也是历史上首个用于SLE的生物制剂，它特异性结合B细胞活化因子（BAFF）的可溶性对应物，这是SLE药物研发的一个突破。贝利尤单抗的疗效和良好的安全性已在多项临床试验和观察性研究中得到证实。在此，我们回顾了相关文献，并基于23项研究总结了贝利尤单抗对SLE患者HRQoL的影响。研究表明，贝利尤单抗可在HRQoL的身体方面以及疲劳方面带来具有临床意义的改善，疲劳是SLE患者常见且主要的主诉。与HRQoL的心理方面相比，SLE患者总体上在身体方面从贝利尤单抗中获益更多。然而，尽管使用贝利尤单抗治疗后临床和免疫特征有所改善，但仍有相当比例的患者对HRQoL的感知仍不令人满意。最后，我们的综述表明，在研究和临床实践中，迫切需要优化患者报告结局指标的使用。
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