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

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.<br/>

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.<br/>

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 &lt;30.28 kg/m2; -0.40 vs 0 mg/L for BMI &ge;30.28 kg/m2).<br/>

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.<br /><br />ClinicalTrials.gov Registry for REACH: <span>NCT</span>00735787<br /><br /><em>J Drugs Dermatol. </em>2016;15(5):562-566.