Joy Ashna, Muralidharan Abilash, Alfaraj Marwa, Shantharam Darshan, Cherukuri Akhila Sai Sree, Muthukumar Arun
Internal Medicine, AP Varkey Mission Hospital, Ernakulam, IND.
Internal Medicine, Kiruba Hospital, Coimbatore, IND.
Cureus. 2022 Jun 13;14(6):e25887. doi: 10.7759/cureus.25887. eCollection 2022 Jun.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple systems with a range of clinical presentations caused by the production of antibodies, activation of complements, and deposition of immune complexes. The exact cause of SLE is still unknown. The effectiveness of traditional treatment methods for SLE is very little. Nowadays, resistance to conventional therapy, steroids, and immunosuppressants is common among SLE patients. Patients with refractory disease and nephritis generally have severe drug-induced toxicity which contributes to organ dysfunction, despite available therapies. Different biologic agents and therapeutic antibodies have become an alternative and have been under experiment in clinical trials, enrolling patients whose disease is inadequately controlled by conventional treatment. Belimumab is the only targeted therapy approved for SLE treatment. This systematic review discusses one such biological agent for treating systemic lupus erythematosus, namely, belimumab. The systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies included randomized clinical trials (RCTs) from 2005 to 2021 on adult SLE. patients treated with monoclonal antibodies to assess the efficacy and safety. Methodological quality was assessed using PubMed, PMC, the Cochrane Risk of Bias tool, and the QUality In Prognosis Studies Tool (QUIPS) for RCTs. Two independent reviewers performed an electronic search on MEDLINE, Cochrane Library, SCIELO, Scopus, and ResearchGate. Based on a systematic review of articles we found that belimumab appears to be efficacious and generally well-tolerated in the treatment of SLE as compared to other drugs. The long-term use of belimumab combined with standard therapy showed a low incidence of organ damage. A lower incidence of organ damage was seen after initiating treatment in patients with a high risk for organ dysfunction. Patients who test for antinuclear antibody or anti-dsDNA-positive SLE, with moderate symptoms in the skin and musculoskeletal systems despite immunosuppressants, are treated with belimumab as an adjunct therapy. Patients with severe lupus nephritis or active CNS lupus cannot be treated with belimumab. Belimumab is effective in most races, as a clinical trial done in North-East Asia showed improvement in SLE symptoms and decreased dependence on prednisone. Belimumab also decreased disease activity and severe flares. Belimumab had greater efficacy in children.
系统性红斑狼疮(SLE)是一种慢性自身免疫性疾病,累及多个系统,临床表现多样,由抗体产生、补体激活及免疫复合物沉积所致。SLE的确切病因尚不清楚。传统治疗方法对SLE的疗效甚微。如今,SLE患者对传统疗法、类固醇和免疫抑制剂产生耐药性很常见。尽管有可用的治疗方法,但难治性疾病和肾炎患者通常有严重的药物诱导毒性,这会导致器官功能障碍。不同的生物制剂和治疗性抗体已成为一种替代方法,并正在临床试验中进行试验,招募那些疾病未得到传统治疗充分控制的患者。贝利尤单抗是唯一被批准用于SLE治疗的靶向疗法。本系统评价讨论了一种用于治疗系统性红斑狼疮的生物制剂,即贝利尤单抗。该系统评价是按照系统评价和Meta分析的首选报告项目(PRISMA)指南进行的。纳入的研究包括2005年至2021年关于成年SLE患者接受单克隆抗体治疗以评估疗效和安全性的随机临床试验(RCT)。使用PubMed、PMC、Cochrane偏倚风险工具以及用于RCT的预 后研究质量工具(QUIPS)评估方法学质量。两名独立评审员在MEDLINE、Cochrane图书馆、SCIELO、Scopus和ResearchGate上进行了电子检索。基于对文章的系统评价,我们发现与其他药物相比,贝利尤单抗在治疗SLE方面似乎有效且总体耐受性良好。长期使用贝利尤单抗联合标准疗法显示器官损伤发生率较低。在器官功能障碍高风险患者开始治疗后,器官损伤发生率较低。抗核抗体或抗双链DNA阳性的SLE患者,尽管使用了免疫抑制剂,但皮肤和肌肉骨骼系统症状中等,可将贝利尤单抗作为辅助疗法进行治疗。严重狼疮性肾炎或活动性中枢神经系统狼疮患者不能使用贝利尤单抗治疗。贝利尤单抗在大多数种族中都有效,正如在东北亚进行的一项临床试验显示SLE症状有所改善且对泼尼松的依赖性降低。贝利尤单抗还降低了疾病活动度和严重发作次数。贝利尤单抗在儿童中疗效更佳。