Rheumatology Department. Hospital Universitario San Agustín, Avilés, Spain.
Rheumatology Division, Hospital Universitari de la Santa Creu i Sant Pau, Barcelona, Spain.
Reumatol Clin (Engl Ed). 2021 Mar;17(3):170-174. doi: 10.1016/j.reuma.2020.03.003. Epub 2020 May 22.
To evaluate the efficacy and safety of belimumab in patients with Primary Sjögren's syndrome (pSS).
The search included manuscripts assessing the efficacy or safety of belimumab in patients with pSS (American-European Consensus Criteria 2002) published between 2004 and 2017 in MEDLINE, EMBASE or Cochrane databases. Two reviewers independently selected the articles, extracted data and evaluated the quality of the evidence following Scottish Intercollegiate Guidelines Network (SIGN) recommendation grades.
Out of 135 citations, only 3 articles were included. All of them publishing results from the same study at different time points including 28 patients. At week 28 improvement was reported for visual analogue scale (VAS) dryness score and glandular manifestations in 37% and 77% of patients, respectively, which persisted at week 52 (W52). Belimumab was well tolerated and safely administered.
Published evidence to determine the efficacy of belimumab in pSS is limited. Belimumab seems to be effective to reduce systemic activity, parotid enlargement, lymphadenopathies, articular manifestation and B cell biomarkers.
评估贝利尤单抗治疗原发性干燥综合征（pSS）患者的疗效和安全性。
检索了 2004 年至 2017 年间在 MEDLINE、EMBASE 或 Cochrane 数据库中发表的评估贝利尤单抗治疗 pSS（2002 年美国-欧洲共识标准）患者疗效或安全性的文献。两位审稿人独立筛选文章、提取数据，并按照苏格兰校际指南网络（SIGN）的建议等级评估证据质量。
在 135 条引文记录中，仅纳入了 3 篇文章。这 3 篇文章均报道了来自同一研究的不同时间点的结果，共纳入 28 例患者。在 28 周时，分别有 37%和 77%的患者视觉模拟量表（VAS）干燥评分和腺体表现得到改善，这些改善在第 52 周（W52）时仍持续存在。贝利尤单抗具有良好的耐受性和安全性。
目前确定贝利尤单抗治疗 pSS 疗效的证据有限。贝利尤单抗似乎可有效降低系统性疾病活动度、腮腺肿大、淋巴结病、关节表现和 B 细胞生物标志物。
