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银屑病关节炎影像学进展的风险因素:ADEPT 随机对照试验的亚组分析。

Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT.

机构信息

University of Toronto, 399 Bathurst Street, Room 1E-410B, Toronto, Ontario M5T 2S8, Canada.

出版信息

Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.

Abstract

INTRODUCTION

To identify independent predictors of radiographic progression in psoriatic arthritis (PsA) for patients treated with adalimumab or placebo in the Adalimumab Effectiveness in PsA Trial (ADEPT).

METHODS

Univariate analyses and multivariate linear regression analyses assessed risk for radiographic progression (change in modified total Sharp score, DeltamTSS>0.5) from baseline to week 24 for C-reactive protein (CRP) and other baseline variables, and for 24-week time-averaged CRP (univariate analysis only). Subanalyses determined mean DeltamTSS for CRP subgroups. Analyses were post hoc, with observed data.

RESULTS

One hundred and forty-four adalimumab-treated patients and 152 placebo-treated patients were assessed. Mean CRP was 64% lower by week 2 with adalimumab and essentially unchanged with placebo. Univariate analyses indicated that elevated CRP at baseline and time-averaged CRP were strongly associated with radiographic progression for placebo-treated patients but not for adalimumab-treated patients. Multivariate analysis confirmed that elevated baseline CRP was the only strong independent risk factor for radiographic progression (for CRP>or=1.0 mg/dl: odds ratio=3.28, 95% confidence interval=1.66 to 6.51, P<0.001). Adalimumab treatment reduced risk of progression approximately fivefold. The difference between mean DeltamTSS for adalimumab versus placebo was greatest for patients with baseline CRP>or=2.0 mg/dl (-0.5 vs. 2.6).

CONCLUSIONS

Systemic inflammation in PsA, as indicated by elevated baseline CRP, was the only strong independent predictor of radiographic progression. This association was observed predominantly for placebo-treated patients. Adalimumab treatment substantially reduced the overall risk of radiographic progression, and provided greatest radiographic benefit for patients with the greatest CRP concentrations at baseline.

TRIAL REGISTRATION

Trial registration: NCT00195689.

摘要

介绍

为了在接受阿达木单抗或安慰剂治疗的银屑病关节炎(PsA)患者中确定放射学进展的独立预测因子,我们进行了阿达木单抗有效性试验(ADEPT)。

方法

采用单变量分析和多变量线性回归分析,评估基线至 24 周时 C 反应蛋白(CRP)和其他基线变量对放射学进展(改良总 Sharp 评分变化,DeltamTSS>0.5)的风险,以及 24 周时的平均 CRP(仅单变量分析)。亚组分析确定 CRP 亚组的平均 DeltamTSS。分析为事后分析,采用观察数据。

结果

共评估了 144 例接受阿达木单抗治疗的患者和 152 例接受安慰剂治疗的患者。阿达木单抗治疗后第 2 周时 CRP 降低了 64%,而安慰剂组的 CRP 基本不变。单变量分析表明,基线时 CRP 升高和平均 CRP 与安慰剂组患者的放射学进展密切相关,但与阿达木单抗组患者无关。多变量分析证实,基线时 CRP 升高是放射学进展的唯一强独立危险因素(对于 CRP>或=1.0mg/dl:比值比=3.28,95%置信区间=1.66 至 6.51,P<0.001)。阿达木单抗治疗使进展的风险降低了约五倍。阿达木单抗与安慰剂相比,基线 CRP>或=2.0mg/dl 的患者的平均 DeltamTSS 差异最大(-0.5 与 2.6)。

结论

PsA 中的全身炎症,如基线 CRP 升高,是放射学进展的唯一强独立预测因子。这种关联主要见于接受安慰剂治疗的患者。阿达木单抗治疗可显著降低放射学进展的总体风险,并为基线时 CRP 浓度最高的患者提供最大的放射学获益。

试验注册

试验注册:NCT00195689。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f2a/2911906/ab7001b4e64c/ar3049-1.jpg

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