TY - JOUR
T1 - Etanercept and clinical outcomes, fatigue, and depression in psoriasis
T2 - Double-blind placebo-controlled randomised phase III trial
AU - Tyring, Stephen
AU - Gottlieb, Alice
AU - Papp, Kim
AU - Gordon, Ken
AU - Leonardi, Craig
AU - Wang, Andrea
AU - Lalla, Deepa
AU - Woolley, Michael
AU - Jahreis, Angelika
AU - Zitnik, Ralph
AU - Cella, David
AU - Krishnan, Ranga
N1 - Funding Information:
We thank Nadia Daizadeh for statistical expertise and Elizabeth H Z Thompson for assistance in writing the manuscript. Both are employees of Amgen. This study was funded by Immunex, a wholly owned subsidiary of Amgen, and by Wyeth Research.
PY - 2006/1/7
Y1 - 2006/1/7
N2 - Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with ClinicalTrials.gov with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p<0·0001; difference 42%, 95% CI 36-48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5·0 vs 1·9; p<0·0001, difference 3·0, 95% CI 1·6-4·5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.
AB - Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with ClinicalTrials.gov with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p<0·0001; difference 42%, 95% CI 36-48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5·0 vs 1·9; p<0·0001, difference 3·0, 95% CI 1·6-4·5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.
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U2 - 10.1016/S0140-6736(05)67763-X
DO - 10.1016/S0140-6736(05)67763-X
M3 - Article
C2 - 16399150
AN - SCOPUS:29844440963
SN - 0140-6736
VL - 367
SP - 29
EP - 35
JO - The Lancet
JF - The Lancet
IS - 9504
ER -