Effectiveness of Rituximab in Patients with Rheumatoid Arthritis: Observational Study from the British Society for Rheumatology Biologics Register

Effectiveness of Rituximab in Patients with Rheumatoid Arthritis: Observational Study from the British Society for Rheumatology Biologics Register
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DOI:
10.3899/jrheum.110610
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发表时间:
2012-02-01
影响因子:
3.9
通讯作者:
Ashcroft, Darren M.
Ashcroft, Darren M.
中科院分区:
医学2区
文献类型:
--
作者:
Soliman, Moetaza M.;Hyrich, Kimme L.;Ashcroft, Darren M.

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Objective.评估利妥昔单抗(RTX)在常规临床实践中对类风湿关节炎(RA)患者的有效性,并确定至少1种抗肿瘤坏死因子-α(抗TNF)治疗失败的患者对RTX 6个月反应的预测因素。该分析涉及646例在英国风湿病学会生物制剂注册处(BSRBR)注册的RA患者,他们开始使用RTX,并随访至少6个月。28关节疾病活动度评分(DAS 28)、欧洲抗风湿联盟(EULAR)反应和达到疾病缓解的患者比例的变化用于评估开始RTX后6个月的临床反应。回归分析用于确定与抗TNF治疗无效患者的反应相关的因素。模型包括基线人口统计学资料、疾病特征、基线健康评估问卷(HAQ)和药物史(包括生物学史)。基线时的平均DAS 28为6.2(95% CI 6.1,6.3),6个月随访时显著降至4.8(95% CI 4.7,4.9)。17%的患者为EULAR良好反应者,43%为中度反应者。8%的患者获得了疾病缓解。基线DAS 28评分较高的受试者和类风湿因子(RF)阳性的受试者与DAS 28评分降低(改善)显著相关,而女性和基线HAQ评分较高的患者改善的可能性较小。RTX已被证明在常规临床实践中有效。当抗TNF治疗失败时,对RTX的反应受基线DAS 28评分、RF状态、基线HAQ评分和性别的影响。(2011年12月15日首次发布; J Rheumol 2012;39:240-6; doi:10.3899/jrheum.110610)
Objective. 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-alpha (anti-TNF) therapy has failed.Method. 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.Results. 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.Conclusion. 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. (First Release Dec 152011; J Rheumatol 2012;39:240-6; doi:10.3899/jrheum.110610)