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764例接受抗肿瘤坏死因子α治疗的银屑病关节炎患者的治疗反应、药物生存期及其预测因素:来自丹麦全国性DANBIO注册研究的结果

Treatment response, drug survival, and predictors thereof in 764 patients with psoriatic arthritis treated with anti-tumor necrosis factor α therapy: results from the nationwide Danish DANBIO registry.

作者信息

Glintborg Bente, Østergaard Mikkel, Dreyer Lene, Krogh Niels Steen, Tarp Ulrik, Hansen Michael Sejer, Rifbjerg-Madsen Signe, Lorenzen Tove, Hetland Merete Lund

机构信息

Gentofte University Hospital, Hellerup, Denmark.

出版信息

Arthritis Rheum. 2011 Feb;63(2):382-90. doi: 10.1002/art.30117.

Abstract

OBJECTIVE

To investigate disease activity, treatment response, and drug survival, and predictors thereof, among Danish patients with psoriatic arthritis (PsA) receiving their first treatment series with a tumor necrosis factor α (TNFα) inhibitor.

METHODS

Patients with PsA were identified from a prospective nationwide rheumatologic database, the Danish biologics registry DANBIO, using data registered from 2000-2009. Information was obtained on the patients' clinical response to anti-TNFα treatment (defined as achievement of the American College of Rheumatology 20% [ACR20], ACR50, and ACR70 improvement criteria or a European League Against Rheumatism [EULAR] good response at least once during the first 6 months of treatment) and duration and rate of drug adherence (referred to as drug survival), as well as predictors thereof.

RESULTS

Of 764 patients with PsA, 320 received adalimumab, 260 infliximab, and 184 etanercept. Median drug survival was 2.9 years, and 1-year and 2-year drug survival rates were 70% and 57%, respectively. Clinical parameters that showed improvement over 6 months were the C-reactive protein (CRP) level, Health Assessment Questionnaire score, and 28-joint Disease Activity Score. Male sex, CRP level >10 mg/liter, concomitant methotrexate use, and low patient health visual analog scale score at baseline were associated with longer drug survival. Improvement was achieved by 59%, 45%, 24%, and 54% of patients according to the ACR20, ACR50, ACR70 response criteria and EULAR good response, respectively. A CRP level >10 mg/liter was predictive of the improvement responses (odds ratio [OR] 2.6 for ACR20, OR 3.0 for ACR50, OR 3.6 for ACR70, and OR 2.2 for EULAR good response).

CONCLUSION

In these patients with PsA treated with their first TNFα inhibitor in clinical practice, high drug adherence and responder rates were observed. Moreover, increased levels of CRP at baseline were associated with both good treatment responses and continued treatment, which may be of clinical value in selecting the patients most likely to benefit from treatment with TNFα inhibitors.

摘要

目的

在接受首个肿瘤坏死因子α(TNFα)抑制剂治疗疗程的丹麦银屑病关节炎(PsA)患者中,调查疾病活动度、治疗反应、药物留存率及其预测因素。

方法

利用2000年至2009年登记的数据,从全国前瞻性风湿病数据库丹麦生物制剂注册库DANBIO中识别出PsA患者。获取了患者对抗TNFα治疗的临床反应信息(定义为在治疗的前6个月内至少一次达到美国风湿病学会20%[ACR20]、ACR50和ACR70改善标准或欧洲抗风湿病联盟[EULAR]良好反应)以及药物依从性的持续时间和比率(称为药物留存率)及其预测因素。

结果

764例PsA患者中,320例接受阿达木单抗治疗,260例接受英夫利昔单抗治疗,184例接受依那西普治疗。药物留存的中位数为2.9年,1年和2年药物留存率分别为70%和57%。在6个月内显示改善的临床参数有C反应蛋白(CRP)水平、健康评估问卷评分和28关节疾病活动评分。男性、CRP水平>10mg/L、同时使用甲氨蝶呤以及基线时患者健康视觉模拟量表评分低与更长的药物留存时间相关。根据ACR20、ACR50、ACR70反应标准和EULAR良好反应,分别有59%、45%、24%和54%的患者实现了改善。CRP水平>10mg/L可预测改善反应(ACR20的比值比[OR]为2.6,ACR50为3.0,ACR70为3.6,EULAR良好反应为2.2)。

结论

在这些临床实践中接受首个TNFα抑制剂治疗的PsA患者中,观察到了较高的药物依从性和反应率。此外,基线时CRP水平升高与良好的治疗反应和持续治疗均相关,这在选择最可能从TNFα抑制剂治疗中获益的患者方面可能具有临床价值。

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