Department of Rheumatology, Karolinska University Hospital, Stockholm, Sweden.
Ann Rheum Dis. 2011 Sep;70(9):1575-80. doi: 10.1136/ard.2010.148759. Epub 2011 May 12.
To assess the 6-month effectiveness of the first rituximab (RTX) course in rheumatoid arthritis (RA) and to identify possible predictors of response.
10 European registries submitted anonymised datasets (baseline, 3- and 6-month follow-up) from patients with RA who had started RTX, and datasets were pooled and analysed. Heterogeneity between countries was analysed by analysis of variance. Predictors of response were identified by logistic regression.
2019 patients were included (mean age/disease duration 53.8/12.1 years, 80.3% female, 85.6% rheumatoid factor (RF) positive and 76.8% (456/594 patients) anti-cyclic citrullinated peptide antibodies (anti-CCP) positive). For these patients an average of 2.7 disease-modifying antirheumatic drugs (DMARDs) (range 0-10) had failed, and RTX was given as the first biological agent in 36.6% of patients. There was significant heterogeneity between countries for several baseline characteristics, including the number of previous biological agents. Disease Activity Score based on 28 joint counts (DAS28) decreased from 5.8±1.4 at baseline to 4.2±1.4 at 6 months (p<0.0001) and 22.2%/42.5% achieved European League Against Rheumatism (EULAR) good/moderate response. Larger 6-month improvement in DAS28 was observed in RF-positive and anti-CCP-positive versus seronegative patients. The following predictors of EULAR good response at 6 months were identified in a multivariate analysis: anti-CCP positivity (OR=2.86, p=0.003), number of previous DMARDs (OR=0.84, p=0.06), ≤1 previous biological agents (OR=1.89, p=0.04), baseline DAS28 level (OR=0.74, p=0.003).
In this large observational cohort of patients with RA treated with RTX, seropositive patients achieved significantly greater reductions in DAS28 at 6 months than seronegative patients. Effectiveness was best when RTX was used as the first biological agent or after failure of no more than one anti-tumour necrosis factor agent.
评估类风湿关节炎（RA）患者首次利妥昔单抗（RTX）治疗的 6 个月疗效，并确定可能的反应预测因子。
10 个欧洲注册中心提交了接受 RTX 治疗的 RA 患者的匿名数据集（基线、3 个月和 6 个月随访），并对数据集进行了汇总和分析。通过方差分析分析了国家间的异质性。通过逻辑回归确定了反应的预测因子。
共纳入 2019 例患者（平均年龄/疾病持续时间 53.8/12.1 岁，80.3%为女性，85.6%为类风湿因子（RF）阳性，76.8%（456/594 例）为抗环瓜氨酸肽抗体（抗-CCP）阳性）。这些患者平均有 2.7 种疾病修饰抗风湿药物（DMARDs）（范围 0-10）治疗失败，36.6%的患者将 RTX 作为首种生物制剂。几个基线特征，包括之前使用生物制剂的数量，在国家间存在显著异质性。基于 28 个关节计数的疾病活动评分（DAS28）从基线时的 5.8±1.4 降至 6 个月时的 4.2±1.4（p<0.0001），22.2%/42.5%达到欧洲抗风湿病联盟（EULAR）良好/中等反应。与血清阴性患者相比，RF 阳性和抗-CCP 阳性患者在 6 个月时 DAS28 的改善更大。多变量分析确定了 6 个月时 EULAR 良好反应的以下预测因子：抗-CCP 阳性（OR=2.86，p=0.003）、之前使用的 DMARDs 数量（OR=0.84，p=0.06）、之前使用的生物制剂≤1 种（OR=1.89，p=0.04）、基线 DAS28 水平（OR=0.74，p=0.003）。
在这项接受 RTX 治疗的 RA 患者大型观察性队列研究中，血清阳性患者在 6 个月时 DAS28 的降低幅度明显大于血清阴性患者。当 RTX 作为首种生物制剂或在使用不超过一种抗肿瘤坏死因子制剂失败后使用时，疗效最佳。
