目的:开放标签,prospective,为调查临床反应而创建的非受控研究,希腊类风湿关节炎(RA)患者的血清学变化和副作用,利妥昔单抗清除B细胞后。
方法:选择具有高疾病活动性(疾病活动性评分[DAS]-28>5.1)的患者使用利妥昔单抗治疗,并接受两次输注,每个1gr,相隔两周。不同的疾病参数(视觉模拟量表,DAS-28,C反应蛋白[CRP],红细胞沉降率,健康评估问卷,补码(C3),C4,类风湿因子[RF],抗环瓜氨酸肽抗体[抗CCP],肿胀的关节计数,招标接头计数,免疫球蛋白M[IgM],IgG,IgA)在基线进行,治疗后2、4和6个月。根据美国风湿病学会(ACR)标准定义反应。
结果:17例患者接受治疗。治疗导致各种疾病参数的降低。到第8周,41.11%的患者达到ACR20,到第16周达到52.94%,到第24周达到82.35%。ACR50在第8周时达到5.88%,在第16周时达到41.17%,在第24周时达到64.7%。23.52%的患者仅在第24周达到ACR70。统计分析显示临床反应没有差异,射频阳性/阴性患者之间,和抗CCP阳性/阴性患者,而RF的下降与DAS-28的减少比与抗CCP更好。
结论:利妥昔单抗在RA中具有良好的耐受性和有效性。反应与RF或抗CCP阳性无关。RF的下降与临床反应以及DAS-28和CRP的降低有关。
OBJECTIVE: An open-label, prospective, uncontrolled study created to investigate clinical response, serological changes and side effects in Greek patients with rheumatoid arthritis (RA), after B-cell depletion with rituximab.
METHODS: Patients with high disease activity (disease activity score [DAS]-28 > 5.1) were selected for treatment with rituximab and received two infusions, 1 gr each, 2 weeks apart. Different disease parameters (visual analog scale, DAS-28, C-reactive protein [CRP], erythrocyte sedimentation rate, health assessment questionnaire, complement (C3), C4, rheumatoid factor [RF], anti-cyclic citrullinated peptide antibody [anti-CCP], swollen joint count, tender joint count, immunoglobulin M [IgM], IgG, IgA) were performed at base line, 2, 4, and 6 months post-treatment. Response was defined according to the American College of Rheumatology (ACR) criteria.
RESULTS: Seventeen patients received therapy. Treatment led to a reduction in various disease parameters. ACR20 was achieved in 41.11% of patients by week 8, 52.94% by week 16, and 82.35% by week 24. ACR50 was achieved in 5.88% by week 8, 41.17% by week 16, and 64.7% by week 24. ACR70 was achieved only by week 24 in 23.52% of patients. Statistical analysis has shown no differences in clinical response, between RF positive/negative patients, and anti-CCP-positive/negative patients, while decline of RF was better correlated with reduction of DAS-28 than with anti-CCP.
CONCLUSIONS: Rituximab is a well tolerated and effective treatment in RA. Response was not correlated to RF or anti-CCP positivity. Decline of RF was associated with clinical response and reduction of DAS-28 and CRP.