The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of Pediatrics, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Front Immunol. 2022 Jul 27;13:940416. doi: 10.3389/fimmu.2022.940416. eCollection 2022.
Childhood systemic lupus erythematosus (cSLE) is a complex multisystem autoimmune disease. In 2019, belimumab was approved for the clinical treatment for cSLE, making it the only biological agent approved for cSLE children aged 5 and older in 60 years.
To review emerging evidence on belimumab in cSLE published up to April 2022, so as to provide information for clinical decision-making.
A comprehensive search of relevant publications up to the date of April 2022 in PUBMED, EMBASE, WOS, COCHRANE, ClinicalTrials.gov, CBM, CNKI and WANFANG was performed using the following criteria: (a) English and Chinese language studies; (b) RCT studies, cohort studies, or case-control studies; (c) patients with age <18; (d) Observational studies or case series studies contain more than 5 patients. All relevant literature was independently screened and reviewed by at least two reviewers and the obtained literature data were extracted and reviewed by two authors.
Five publications met the inclusion/exclusion criteria for cSLE: one randomized controlled trial, one retrospective cohort study, and three case series. There was a high degree of heterogeneity among several studies, and the availability of baseline and outcome data provided was uneven.
At present, there is a lack of high-quality clinical trials of belimumab in the treatment of cSLE. Based on the current research, it is believed that the use of belimumab can inhibit cSLE activity, reduce the dose of corticosteroids and immunosuppressants, and delay kidney damage. Also it shows clinical benefit in alleviating symptoms of monogenic cSLE refractory to standard therapy. More studies are urgently needed to validate the clinical efficacy of belimumab in cSLE and to evaluate its long-term safety in pediatric populations to promote evidence-based practice.
儿童系统性红斑狼疮（cSLE）是一种复杂的多系统自身免疫性疾病。2019 年，贝利尤单抗被批准用于 cSLE 的临床治疗，使其成为 60 年来唯一批准用于 5 岁及以上 cSLE 儿童的生物制剂。
综述截至 2022 年 4 月发表的有关贝利尤单抗治疗 cSLE 的新证据，为临床决策提供信息。
通过 PUBMED、EMBASE、WOS、COCHRANE、ClinicalTrials.gov、CBM、CNKI 和 WANFANG 数据库，以英文和中文检索了截至 2022 年 4 月的相关文献，检索词为“belimumab”“儿童系统性红斑狼疮”。纳入标准：（a）英语和中文文献；（b）RCT 研究、队列研究或病例对照研究；（c）年龄＜18 岁的患者；（d）包含 5 例以上患者的观察性研究或病例系列研究。由至少 2 位评审员独立筛选和评价所有相关文献，并由 2 位作者提取和评价文献数据。
符合纳入/排除标准的 cSLE 文献有 5 篇：1 项随机对照试验、1 项回顾性队列研究和 3 项病例系列研究。多项研究间存在高度异质性，且基线和结局数据的可获得性参差不齐。
目前，贝利尤单抗治疗 cSLE 的高质量临床试验较少。基于现有研究，我们认为贝利尤单抗的使用可抑制 cSLE 活动，减少皮质激素和免疫抑制剂的剂量，延缓肾脏损害。同时，在缓解标准治疗难治性单基因 cSLE 的症状方面也具有临床获益。还需要更多的研究来验证贝利尤单抗治疗 cSLE 的临床疗效，并评估其在儿科人群中的长期安全性，以促进循证实践。
