Rheumatology department, Hospital Marítimo de Torremolinos, Málaga, Spain.
Medical department, GSK, P.T.M Severo Ochoa, 2 - 28760. Tres Cantos, Madrid, Spain.
Clin Rheumatol. 2022 Nov;41(11):3373-3382. doi: 10.1007/s10067-022-06287-9. Epub 2022 Jul 23.
Belimumab was the first biological drug approved for Systemic Lupus Erythematosus (SLE). There is not a review focusing on all real-life experience with belimumab to date that could help to describe how this drug behaves in the Spanish clinical setting.
To describe the characteristics of SLE patients treated with belimumab added to standard of care in real-clinical setting in Spain.
We conducted a comprehensive scoping review of real-world data (RWD) according to PRISMA Scoping Reviews Checklist and the framework proposed by Arksey and O'Malley. PubMed and EMBASE were searched without language restriction and hand searches of relevant articles were examined.
We included data from 222 patients treated with belimumab for SLE included in 19 RWD studies conducted in Spain. The mean age was 40.9 years, 84.2% were female, and baseline scores SELENA-SLEDAI ranged between 5.9 and 12. Lupus nephritis basal prevalence was of 2.7%. The main reason for belimumab initiation was previous treatments lack of efficacy (69.7%) and the most common laboratory abnormalities were hypocomplementemia (40.9%), ANA + (34.2%), and anti-DNA (33.3%). The addition of belimumab to standard therapy was associated with a reduction of daily glucocorticoids intake in 1.4-11.1 mg at 6 months. Belimumab discontinuation was observed in 18.6% of patients.
Our study helps to further explore the profile of SLE patients most likely to be treated with belimumab.
贝利尤单抗是首个获批用于系统性红斑狼疮（SLE）的生物制剂。目前尚无针对贝利尤单抗所有真实世界应用经验的综述，无法帮助描述该药在西班牙临床环境中的表现。
描述在西班牙真实临床环境中，接受贝利尤单抗联合标准治疗的SLE 患者的特征。
我们根据 PRISMA 扩展综述清单和 Arksey 和 O'Malley 提出的框架，对真实世界数据（RWD）进行了全面的范围综述。对 PubMed 和 EMBASE 进行了无语言限制的检索，并对相关文章进行了手工检索。
我们纳入了 19 项在西班牙进行的、包含 222 例接受贝利尤单抗治疗的 SLE 患者的 RWD 研究数据。患者的平均年龄为 40.9 岁，84.2%为女性，SELENA-SLEDAI 基线评分范围为 5.9-12。狼疮肾炎的基础患病率为 2.7%。贝利尤单抗治疗的主要原因是先前治疗无效（69.7%），最常见的实验室异常是低补体血症（40.9%）、ANA（+）（34.2%）和抗 DNA（33.3%）。在 6 个月时，与标准治疗相比，贝利尤单抗联合治疗可使每日糖皮质激素摄入量减少 1.4-11.1mg。18.6%的患者停止使用贝利尤单抗。
我们的研究有助于进一步探索最有可能接受贝利尤单抗治疗的 SLE 患者的特征。
