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接受阿达木单抗治疗的活动性银屑病关节炎患者的临床缓解情况以及关节和皮肤表现的相关性

Clinical remission in patients with active psoriatic arthritis treated with adalimumab and correlations in joint and skin manifestations.

作者信息

Van den Bosch Filip, Kavanaugh Arthur, Kron Martina, Kupper Hartmut, Mease Philip J

机构信息

From the Ghent University Hospital, Ghent, Belgium; University of California at San Diego, La Jolla, California; University of Washington, Swedish Medical Center, Seattle, Washington, USA; AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.F. Van den Bosch, MD, PhD, Ghent University Hospital; A. Kavanaugh, MD, University of California at San Diego; M. Kron, PhD; H. Kupper, MD, AbbVie Deutschland GmbH & Co KG; P.J. Mease, MD, University of Washington, Swedish Medical Center.

出版信息

J Rheumatol. 2015 Jun;42(6):952-9. doi: 10.3899/jrheum.140312. Epub 2015 Apr 1.

Abstract

OBJECTIVE

Adalimumab (ADA) was evaluated for its efficacy in patients with moderate to severely active psoriatic arthritis (PsA) and for the presence of correlations in disease change variables.

METHODS

Patients with inadequate response to standard PsA therapy were given 40 mg of ADA every other week for up to 12 weeks or 20 weeks. Outcome variables encompassed tender joint count (TJC), swollen joint count (SJC), physician's global assessment (PGA) of psoriasis, Health Assessment Questionnaire (HAQ), patient's global assessment (PtGA) of disease activity and pain, C-reactive protein, as well as composite measures of disease activity. Patients with inactive skin disease symptoms at baseline were excluded from the remission analyses.

RESULTS

Of 268 patients with active baseline joint and skin disease and data available at Week 12 following open-label ADA therapy, 73 achieved joint remission (27.2%, TJC ≤ 1 + SJC ≤ 1) and 144 achieved skin remission criteria (53.7%, PGA = clear/almost clear). Simultaneous joint and skin remission criteria were achieved in 16.0% and 24.8% of patients at weeks 12 and 20, respectively. In patients who did not achieve skin and/or joint remission, 12-week ADA treatment improved mean clinical and functional scores. Joint remission was more frequently associated with achieving clinically relevant outcomes including HAQ, PtGA disease activity, and PtGA pain compared to skin remission. No correlation between improvement in skin and joint disease was observed.

CONCLUSION

ADA was effective in achieving strict criteria for remission in joint or skin disease in many patients with active PsA within 12 weeks and sustained through 20 weeks. (NCT00235885).

摘要

目的

评估阿达木单抗(ADA)治疗中度至重度活动性银屑病关节炎(PsA)患者的疗效,以及疾病变化变量之间的相关性。

方法

对标准PsA治疗反应不佳的患者每隔一周给予40mg ADA,治疗时间长达12周或20周。结果变量包括压痛关节计数(TJC)、肿胀关节计数(SJC)、医生对银屑病的整体评估(PGA)、健康评估问卷(HAQ)、患者对疾病活动和疼痛的整体评估(PtGA)、C反应蛋白以及疾病活动的综合指标。基线时无皮肤疾病活动症状的患者被排除在缓解分析之外。

结果

在268例基线时有活动性关节和皮肤疾病且在开放标签ADA治疗12周后有可用数据的患者中,73例实现了关节缓解(27.2%,TJC≤1 + SJC≤1),144例达到了皮肤缓解标准(53.7%,PGA = 清除/几乎清除)。在第12周和第20周时,分别有16.0%和24.8%的患者同时达到关节和皮肤缓解标准。在未实现皮肤和/或关节缓解的患者中,12周的ADA治疗改善了平均临床和功能评分。与皮肤缓解相比,关节缓解更常与达到包括HAQ、PtGA疾病活动和PtGA疼痛等临床相关结局相关。未观察到皮肤和关节疾病改善之间的相关性。

结论

ADA在12周内使许多活动性PsA患者有效达到关节或皮肤疾病的严格缓解标准,并持续至20周。(NCT00235885)

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