Dass S, Bowman S J, Vital E M, Ikeda K, Pease C T, Hamburger J, Richards A, Rauz S, Emery P
Academic Unit of Musculoskeletal Disease, University of Leeds, Leeds, UK.
Ann Rheum Dis. 2008 Nov;67(11):1541-4. doi: 10.1136/ard.2007.083865. Epub 2008 Feb 14.
Primary Sjögren syndrome (pSS) causes significant systemic symptoms including fatigue as well as glandular dysfunction. There are currently no effective systemic therapies; however, open label series have suggested that rituximab may be beneficial for systemic and glandular manifestations. Therefore, we performed a double blind, placebo-controlled, randomised pilot study of the efficacy of rituximab in reducing fatigue in pSS.
A total of 17 patients with pSS and a score on fatigue visual analogue scale (VAS) >50 were randomised to receive either 2 infusions of rituximab 1 g or placebo; patients also received oral and intravenous steroids. Outcome measures included: the proportion of patients with >20% reduction in fatigue VAS, changes in pSS related symptoms, health related quality of life and immunological parameters of pSS. These were measured 6 months after therapy.
There was significant improvement from baseline in fatigue VAS in the rituximab group (p<0.001) in contrast to the placebo group (p = 0.147). There was a significant difference between the groups at 6 months in the social functioning score of SF-36 (p = 0.01) and a trend to significant difference in the mental health domain score of SF-36 (p = 0.06). There was one episode of serum sickness in the rituximab treated group.
This is the first double blind study of rituximab in pSS to show benefit; further studies are justified.
原发性干燥综合征（pSS）会引发包括疲劳在内的显著全身症状以及腺体功能障碍。目前尚无有效的全身治疗方法；然而，开放标签系列研究表明利妥昔单抗可能对全身和腺体表现有益。因此，我们进行了一项双盲、安慰剂对照、随机的试点研究，以评估利妥昔单抗减轻pSS患者疲劳的疗效。
共有17例pSS患者，其疲劳视觉模拟量表（VAS）评分>50，被随机分为接受2次1g利妥昔单抗输注或安慰剂治疗；患者还接受了口服和静脉注射类固醇。观察指标包括：疲劳VAS评分降低>20%的患者比例、pSS相关症状的变化、健康相关生活质量以及pSS的免疫参数。这些指标在治疗后6个月进行测量。
与安慰剂组（p = 0.147）相比，利妥昔单抗组的疲劳VAS评分较基线有显著改善（p<0.001）。两组在6个月时，SF-36社会功能评分存在显著差异（p = 0.01），SF-36心理健康领域评分有显著差异的趋势（p = 0.06）。利妥昔单抗治疗组有1例血清病发作。
这是第一项关于利妥昔单抗治疗pSS显示出益处的双盲研究；有必要进行进一步研究。
