Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice:: the Research in Active Rheumatoid Arthritis (ReAct) trial
Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice:: the Research in Active Rheumatoid Arthritis (ReAct) trial
复制标题
DOI：
10.1136/ard.2006.066761
复制
发表时间：
2007-06-01
影响因子：
27.4
通讯作者：
Kupper, Hartmut
中科院分区：
文献类型：
--
作者：
Burmester, Gerd R.;Mariette, Xavier;Kupper, Hartmut
目的：评价阿达木单抗单独或联合标准疾病改善抗风湿药物（DMARDs）治疗类风湿性关节炎（RA）的安全性和有效性。方法：尽管接受过DMARDs治疗或之前接受过肿瘤坏死因子拮抗剂治疗，但患有活动性RA的患者参加了一项多中心、开放标签的临床研究，每隔一周服用40mg阿达木单抗，持续12周，并可选择延长期。允许患者继续使用已有的传统dmard。报告了所有患者（阿达木单抗暴露4210患者年（PYs））的长期安全性结果。根据美国风湿病学会（ACR）和欧洲抗风湿病联盟（EULAR）反应标准报告了第12周观察到的有效性结果。结果：在6610例接受治疗的患者中，阿达木单抗的耐受性普遍良好。3.1%的患者发生严重感染（5.5/100 PYs，包括活动性肺结核，0.5/100 PYs）。脱髓鞘病（0.06%）和系统性红斑狼疮（0.03%）是罕见的严重不良事件。恶性肿瘤的标准化发生率为0.71 （95% CI 0.49 ~ 1.01）。标准化死亡率为1.07 （95% CI 0.75 ~ 1.49）。在第12周，69%的患者达到ACR20缓解，83%为中度缓解，33%为良好的EULAR缓解。阿达木单抗与多种dmard联合使用有效。在抗疟药物中添加阿达木单抗与阿达木单抗和甲氨蝶呤联合使用相当有效。结论：考虑到开放标签研究的局限性，在6610例临床治疗的难治性RA患者中，阿达木单抗单独或联合标准dmard似乎具有良好的耐受性和有效性。
Objective: To evaluate the safety and effectiveness of adalimumab alone or in combination with standard disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA).Methods: Patients with active RA despite treatment with DMARDs or prior treatment with a tumour necrosis factor antagonist participated in a multicentre, open-label clinical study of adalimumab 40 mg every other week for 12 weeks with an optional extension phase. Patients were allowed to continue with pre-existing traditional DMARDs. Long- term safety results are reported for all patients (4210 patient-years (PYs) of adalimumab exposure). The observed effectiveness results at week 12 are reported using American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria.Results: Among the 6610 treated patients, adalimumab was generally well tolerated. Serious infections occurred in 3.1% of patients (5.5/100 PYs, including active tuberculosis, 0.5/100 PYs). Demyelinating disease (0.06%) and systemic lupus erythematosus (0.03%) were rare serious adverse events. The standardised incidence ratio of malignancy was 0.71 (95% CI 0.49 to 1.01). The standardised mortality ratio was 1.07 ( 95% CI 0.75 to 1.49). At week 12, 69% of patients achieved an ACR20 response, 83% a moderate, and 33% a good EULAR response. Adalimumab was effective in combination with a variety of DMARDs. The addition of adalimumab to antimalarials was comparably effective to the combination of adalimumab and methotrexate.Conclusions: Considering the limitations of an open- label study, adalimumab alone or in combination with standard DMARDs appeared to be well tolerated and effective in 6610 difficult- to- treat patients with active RA treated in clinical practice.