Reduction in C-Reactive-Protein Levels With Adalimumab Therapy in Patients With Moderate-to-Severe Hand and/or Foot Psoriasis
May 2016 | Volume 15 | Issue 5 | Original Article | 562 | Copyright © May 2016
Craig L. Leonardi MD,a Kristina Unnebrink PhD,b and Wendell C. Valdecantos MDc
aSaint Louis University School of Medicine, Saint Louis, MO
bAbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany
cAbbVie Inc., North Chicago, IL
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
2; −0.40 vs 0 mg/L for BMI ≥30.28 kg/m
2).
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.
INTRODUCTION
Psoriasis is a systemic, chronic, inflammatory skin disease that can primarily affect the hands and/or feet. In such cases, the condition causes a disproportionately negative impact on patient quality of life due to the visibility, pain, discomfort, and limitations in performing activities of daily living, despite the relatively small body surface area (BSA) affected.1,2
Numerous biomarkers of systemic inflammation are involved in the pathogenesis of psoriasis, including TNF-α, IL-17, and IL-8.3 Humira® (adalimumab), a fully human monoclonal antibody approved in the US and Europe for the treatment of psoriasis, inhibits the TNF-α cytokine, thereby targeting a key inflammatory mechanism in the auto-inflammatory cascade.4 In a phase 4, multicenter, randomized, double-blind trial (REACH), adalimumab was efficacious and well-tolerated for up to 28 weeks of treatment in patients with moderate-to-severe psoriasis of the hands and/or feet.5
We evaluated post hoc whether adalimumab therapy decreased levels of high-sensitivity CRP (hs-CRP), a sensitive marker of systemic inflammation, in patients with moderate-to-severe hand and/or foot psoriasis from the 16-week placebo-controlled period of REACH.
METHODS
Adult patients with psoriasis of the hands and/or feet from REACH were randomized 2:1 to adalimumab 40 mg every other week (following 80 mg at week 0) or matching placebo from weeks 1 up to week 16, followed by a 12-week, open-label extension during which all patients received adalimumab 40 mg every other week.5
Patients were at least 18 years of age, diagnosed with moderate-to-severe chronic plaque psoriasis of the hands and/or feet for at least 6 months, and had psoriatic disease on at least one other cutaneous area. At baseline, patients had a score of
