School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, UK.
J Rheumatol. 2012 Feb;39(2):240-6. doi: 10.3899/jrheum.110610. Epub 2011 Dec 15.
To assess the effectiveness of rituximab (RTX) in patients with rheumatoid arthritis (RA) in routine clinical practice, and to identify predictors of 6-month response to RTX in patients for whom at least 1 anti-tumor necrosis factor-α (anti-TNF) therapy has failed.
The analysis involved 646 patients with RA registered with the British Society for Rheumatology Biologics Register (BSRBR) who were starting RTX and were followed for at least 6 months. Change in the 28-joint Disease Activity Score (DAS28), European League Against Rheumatism (EULAR) response, and proportions of patients achieving disease remission were used to assess the clinical response 6 months after starting RTX. Regression analyses were used to identify factors associated with the response in the patients for whom anti-TNF therapy had not worked. The models included baseline demographics, disease characteristics, baseline Health Assessment Questionnaire (HAQ), and drug history including biologic history.
The mean DAS28 at baseline was 6.2 (95% CI 6.1, 6.3), which decreased significantly to 4.8 (95% CI 4.7, 4.9) at the 6-month followup. Seventeen percent of the patients were EULAR good responders and 43% were moderate responders. Eight percent of the patients achieved disease remission. Subjects with higher baseline DAS28 score and those with positive rheumatoid factor (RF) status were significantly associated with a decrease in their DAS28 score (improvement), while women and patients with higher baseline HAQ score were less likely to improve.
RTX has proven to be effective in routine clinical practice. When anti-TNF therapy fails, response to RTX was influenced by baseline DAS28 score, RF status, baseline HAQ score, and sex.
评估利妥昔单抗（RTX）在常规临床实践中治疗类风湿关节炎（RA）患者的疗效，并确定至少 1 种抗肿瘤坏死因子-α（anti-TNF）治疗失败的患者对 RTX 治疗 6 个月时应答的预测因子。
本分析纳入了在英国风湿病学会生物制剂登记处（BSRBR）注册并开始接受 RTX 治疗且至少随访 6 个月的 646 例 RA 患者。采用 28 关节疾病活动评分（DAS28）、欧洲抗风湿病联盟（EULAR）应答以及达到疾病缓解的患者比例评估开始 RTX 治疗后 6 个月的临床应答。回归分析用于确定对 TNF 治疗无效的患者应答的相关因素。这些模型包括基线人口统计学特征、疾病特征、基线健康评估问卷（HAQ）以及包括生物制剂治疗史在内的药物史。
基线时 DAS28 的平均值为 6.2（95%置信区间 6.1，6.3），在 6 个月随访时显著下降至 4.8（95%置信区间 4.7，4.9）。17%的患者为 EULAR 良好应答者，43%为中度应答者。8%的患者达到疾病缓解。基线 DAS28 评分较高的患者和 RF 阳性的患者其 DAS28 评分明显下降（改善），而女性和基线 HAQ 评分较高的患者则不太可能改善。
RTX 在常规临床实践中已被证明有效。当抗 TNF 治疗失败时，RTX 治疗的应答受基线 DAS28 评分、RF 状态、基线 HAQ 评分和性别影响。
