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阿达木单抗对类风湿关节炎患者工作参与度的影响:一项开放标签扩展研究与基于注册登记的对照组的比较

Impact of adalimumab on work participation in rheumatoid arthritis: comparison of an open-label extension study and a registry-based control group.

作者信息

Halpern M T, Cifaldi M A, Kvien T K

机构信息

Department of Health Policy and Management, Emory University, Atlanta, Georgia 30329, USA.

出版信息

Ann Rheum Dis. 2009 Jun;68(6):930-7. doi: 10.1136/ard.2008.092734. Epub 2008 Oct 1.

Abstract

BACKGROUND AND OBJECTIVES

Rheumatoid arthritis (RA) causes considerable disability and often results in loss of work capacity and productivity. This study evaluated the impact of adalimumab, a tumour necrosis factor antagonist with demonstrated efficacy in RA, on long-term employment.

METHODS

Data from an open-label extension study (DE033) of 486 RA patients receiving adalimumab monotherapy who previously did not respond to at least one disease-modifying antirheumatic drug (DMARD) and had baseline work status information were compared with data from 747 RA patients receiving DMARD treatment in a Norway-based longitudinal registry. Primary outcomes included the time patients continued working at least part time and the likelihood of stopping work. Secondary outcomes included American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) responses and disease remission. Outcomes were compared 6, 12 and 24 months after enrolment.

RESULTS

During a 24-month period, the 158 patients who received adalimumab and were working at baseline worked 7.32 months longer (95% CI 4.8 to 9.1) than did the 180 patients treated with DMARDs, controlling for differences in baseline characteristics. Regardless of baseline work status, patients receiving adalimumab worked 2.0 months longer (95% CI 1.3 to 2.6) and were significantly less likely to stop working than those receiving DMARDs (HR 0.36 (95% CI -0.30 to 0.42) for all patients and 0.36 (95% CI 0.15 to 0.85) for patients working at baseline, respectively). The patients who received adalimumab were also considerably more likely to achieve ACR responses and disease remission than DMARD-treated patients. Patients who achieved EULAR good response and remission were less likely to stop working, but this relationship was only seen in patients receiving DMARDs.

CONCLUSIONS

Patients with RA who received adalimumab experienced considerably longer periods of work and continuous employment, and greater rates of clinical responses, than patients receiving DMARDs. The mechanism by which adalimumab decreases likelihood of stopping work seems to be different from that of DMARD treatment and independent of clinical responses.

摘要

背景与目的

类风湿关节炎(RA)会导致严重残疾,常常致使工作能力和生产力丧失。本研究评估了阿达木单抗(一种已证实在RA中有效的肿瘤坏死因子拮抗剂)对长期就业的影响。

方法

将来自一项开放标签扩展研究(DE033)的486例接受阿达木单抗单药治疗的RA患者的数据与来自挪威一项纵向登记处的747例接受改善病情抗风湿药(DMARD)治疗的RA患者的数据进行比较,前者之前对至少一种DMARD无反应且有基线工作状态信息。主要结局包括患者至少兼职工作的持续时间以及停止工作的可能性。次要结局包括美国风湿病学会(ACR)和欧洲抗风湿病联盟(EULAR)反应以及疾病缓解情况。在入组后6、12和24个月对结局进行比较。

结果

在24个月期间,158例接受阿达木单抗且基线时在工作的患者比180例接受DMARD治疗的患者工作时间长7.32个月(95%可信区间4.8至9.1),已对基线特征差异进行了控制。无论基线工作状态如何,接受阿达木单抗的患者比接受DMARD的患者工作时间长2.0个月(95%可信区间1.3至2.6),且停止工作的可能性显著更低(所有患者的风险比为0.36(95%可信区间 -0.30至0.42),基线时在工作的患者为0.36(95%可信区间0.15至0.85))。接受阿达木单抗的患者比接受DMARD治疗的患者达到ACR反应和疾病缓解的可能性也显著更高。达到EULAR良好反应和缓解的患者停止工作的可能性较小,但这种关系仅在接受DMARD的患者中可见。

结论

与接受DMARD的患者相比,接受阿达木单抗的RA患者工作时间和持续就业时间显著更长,临床反应率更高。阿达木单抗降低停止工作可能性的机制似乎与DMARD治疗不同,且独立于临床反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1be0/2674552/679ab85c72de/ard-68-06-0930-f01.jpg

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