Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet 2006 Jan 07;367(9504):29-35
Date
01/10/2006Pubmed ID
16399150DOI
10.1016/S0140-6736(05)67763-XScopus ID
2-s2.0-29844440963 (requires institutional sign-in at Scopus site) 968 CitationsAbstract
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 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.
Author List
Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, Lalla D, Woolley M, Jahreis A, Zitnik R, Cella D, Krishnan RAuthor
Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Anti-Inflammatory Agents, Non-SteroidalDepression
Double-Blind Method
Etanercept
Fatigue
Female
Humans
Immunoglobulin G
Male
Middle Aged
Psoriasis
Receptors, Tumor Necrosis Factor
Severity of Illness Index
