阿达木单抗治疗中重度手足银屑病患者可降低C反应蛋白水平

Reduction in C-Reactive-Protein Levels With Adalimumab Therapy in Patients With Moderate-to-Severe Hand and/or Foot Psoriasis.

作者信息

Leonardi Craig L, Unnebrink Kristina, Valdecantos Wendell C

出版信息

J Drugs Dermatol. 2016 May 1;15(5):562-6.

Abstract

INTRODUCTION

We evaluated post hoc the relationship between Humira (adalimumab) therapy and high-sensitivity C-reactive protein (hs-CRP) levels in patients with moderate-to-severe hand and/or foot psoriasis from the 16-week placebo-controlled period of REACH.

METHODS

REACH was a phase 4, multicenter, randomized, double-blind trial, evaluating adalimumab treatment for patients with psoriasis of the hands and/or feet. Adults were randomized 2:1 to adalimumab 40 mg every other week (following 80 mg at week 0) or matching placebo from weeks 1 to 16, followed by a 12-week, open-label extension. In this post hoc analysis, changes in hs-CRP were reported as observed from baseline to week 16.

RESULTS

Of the 72 patients (23 placebo, 49 adalimumab) who participated in REACH, 63 (19 placebo, 44 adalimumab) with hs-CRP measurements at baseline and at week 16 were included in this analysis. Baseline median hs-CRP values were 1.6 mg/L (placebo) and 2.2 mg/L (adalimumab), and were 3 times higher for patients with, as compared with those without, psoriatic arthritis (5.45 vs 1.8 mg/L). At week 16, the adalimumab group showed greater improvements (median reduction) from baseline than the placebo group in hs-CRP overall (-0.55 vs +0.10 mg/L), regardless of achievement of PGA of the hands and/or feet (hfPGA) 0 or 1 at week 16 (-0.80 vs 0 mg/L for patients who achieved hfPGA 0/1; -0.40 vs +0.30 mg/L, patients who did not achieve hfPGA 0/1), baseline psoriatic arthritis history (-2.35 mg/L with history [adalimumab group; no history for placebo group]; -0.40 vs +0.10 mg/L without history), and body mass index (BMI) category (defined by median BMI) (-0.80 vs +0.20 mg/L for BMI <30.28 kg/m; -0.40 vs 0 mg/L for BMI ≥30.28 kg/m).

CONCLUSION

Treatment with adalimumab 40 mg every other week resulted in greater overall reductions in hs-CRP levels among patients in this post hoc analysis, compared with placebo at 16 weeks regardless of baseline characteristics.

ClinicalTrials.gov Registry for REACH: NCT00735787

J Drugs Dermatol. 2016;15(5):562-566.

摘要

引言

我们在一项名为REACH的研究中，对中重度手足银屑病患者在16周安慰剂对照期内接受修美乐（阿达木单抗）治疗与高敏C反应蛋白（hs-CRP）水平之间的关系进行了事后评估。

方法

REACH是一项4期、多中心、随机、双盲试验，评估阿达木单抗治疗手足银屑病患者的疗效。成人患者按2:1随机分组，每两周接受一次40mg阿达木单抗治疗（第0周给予80mg）或匹配的安慰剂，治疗16周，随后进入为期12周的开放标签扩展期。在这项事后分析中，报告了从基线到第16周观察到的hs-CRP变化。

结果

参与REACH研究的72例患者（23例安慰剂组，49例阿达木单抗组）中，63例（19例安慰剂组，44例阿达木单抗组）在基线和第16周进行了hs-CRP测量，并纳入本分析。基线时hs-CRP的中位数分别为1.6mg/L（安慰剂组）和2.2mg/L（阿达木单抗组），合并银屑病关节炎的患者是未合并者的3倍（5.45 vs 1.8mg/L）。在第16周时，无论第16周时手足医师全面评估（hfPGA）是否达到0或1（达到hfPGA 0/1的患者为-0.80 vs 0mg/L；未达到hfPGA 0/1的患者为-0.40 vs +0.30mg/L）、基线银屑病关节炎病史（有病史者为-2.35mg/L[阿达木单抗组；安慰剂组无病史]；无病史者为-0.40 vs +0.10mg/L）以及体重指数（BMI）类别（按BMI中位数定义）（BMI<30.28kg/m²者为-0.80 vs +0.20mg/L；BMI≥30.28kg/m²者为-0.40 vs 0mg/L），阿达木单抗组hs-CRP水平较基线的总体改善（中位数降低）均大于安慰剂组。