Efficacy and safety of rituximab treatment in early primary Sjögren's syndrome: a prospective, multi-center, follow-up study.
Efficacy and safety of rituximab treatment in early primary Sjögren's syndrome: a prospective, multi-center, follow-up study.
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DOI：
10.1186/ar4359
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发表时间：
2013-10-30
影响因子：
4.9
通讯作者：
Giacomelli R
中科院分区：
文献类型：
--
作者：
Carubbi F;Cipriani P;Marrelli A;Benedetto P;Ruscitti P;Berardicurti O;Pantano I;Liakouli V;Alvaro S;Alunno A;Manzo A;Ciccia F;Gerli R;Triolo G;Giacomelli R
原发性干燥综合征（pSS）是一种影响外分泌腺的自身免疫性疾病;然而，一个亚组的pSS患者经历全身性腺体外受累，导致疾病预后恶化。目前的治疗选择主要是经验性的，并经常翻译为其他自身免疫性疾病。在过去的几年里，越来越多的证据表明，利妥昔单抗（RTX）消耗B细胞对pSS也有效。早期活动性疾病的患者似乎是那些可以从RTX中获益最多的人。本研究的目的是研究RTX与疾病缓解抗风湿药物（DMARD）相比在早期活动性pSS患者中的疗效和安全性。41例早期pSS和活动性疾病（EULAR干燥综合征疾病活动指数，ESSDAI ≥ 6）患者入组本研究。患者在两个不同的风湿病中心接受RTX或DMARD治疗，并随访120周。通过ESSDAI每12周一次进行临床评估，直至第120周，并在第12、24、48、72、96和120周通过视觉模拟量表、非刺激唾液流量和Schirmer I试验上的自我报告的总体疾病活动疼痛、干燥症状和疲劳进行临床评估。每12周一次进行实验室评估，直至第120周。在入选研究时和第120周，从所有患者中获得两份唇小唾液腺（MSG）活检标本。我们的研究表明，与DMARDs治疗相比，RTX治疗导致ESSDAI和其他临床参数更快，更明显的下降。两组均未报告不良事件。我们还观察到RTX能够减少腺体浸润，干扰B/T区室化，从而干扰pSS-MSG中异位淋巴样结构和生发中心样结构的形成。据我们所知，这是在早期活动性pSS患者的大型队列中进行的第一项为期120周的研究。我们发现RTX是一种安全有效的药物，可用于全身性腺体外受累的pSS患者。此外，我们关于pSS-MSG的数据为在这种疾病中使用RTX提供了额外的生物学基础。
Primary Sjögren’s syndrome (pSS) is an autoimmune disorder affecting exocrine glands; however, a subgroup of pSS patients experience systemic extra-glandular involvement leading to a worsening of disease prognosis. Current therapeutic options are mainly empiric and often translated by other autoimmune diseases. In the last few years growing evidence suggests that B-cell depletion by rituximab (RTX) is effective also in pSS. Patients with early active disease appear to be those who could benefit the most from RTX. The aim of this study was to investigate the efficacy and safety of RTX in comparison to disease modifying anti-rheumatic drugs (DMARDs) in early active pSS patients. Forty-one patients with early pSS and active disease (EULAR Sjogren’s syndrome disease activity index, ESSDAI ≥ 6) were enrolled in the study. Patients were treated with either RTX or DMARDs in two different Rheumatology centers and followed up for 120 weeks. Clinical assessment was performed by ESSDAI every 12 weeks up to week 120 and by self-reported global disease activity pain, sicca symptoms and fatigue on visual analogic scales, unstimulated saliva flow and Schirmer’s I test at week 12, 24, 48, 72, 96, and 120. Laboratory assessment was performed every 12 weeks to week 120. Two labial minor salivary gland (MSG) biopsies were obtained from all patients at the time of inclusion in the study and at week 120. Our study demonstrated that RTX treatment results in a faster and more pronounced decrease of ESSDAI and other clinical parameters compared to DMARDs treatment. No adverse events were reported in the two groups. We also observed that RTX is able to reduce glandular infiltrate, interfere with B/T compartmentalization and consequently with the formation of ectopic lymphoid structures and germinal center-like structures in pSS-MSGs. To our knowledge, this is the first study performed in a large cohort of early active pSS patients for a period of 120 weeks. We showed that RTX is a safe and effective agent to be employed in pSS patients with systemic, extra-glandular involvement. Furthermore, our data on pSS-MSGs provide additional biological basis to employ RTX in this disease.
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