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Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial.
Br J Dermatol. 2005 Dec; 153(6):1192-9.BJ

Abstract

BACKGROUND

Etanercept, a soluble tumour necrosis factor receptor, lessens the severity of psoriasis as measured by physician-reported clinical outcomes. Equally important is the patient perspective on the effect of etanercept therapy on daily life.

OBJECTIVES

To assess patient-reported outcomes (PROs) in patients with psoriasis receiving etanercept therapy.

METHODS

In this multinational, randomized, phase III trial, patients with psoriasis received placebo (n = 193), etanercept 50 mg per week (n = 196) or etanercept 50 mg twice weekly (n = 194) during the initial 12-week, double-blind period. Thereafter, all patients received open-label etanercept (50 mg per week). The following PROs were assessed: Dermatology Life Quality Index (DLQI), Short Form-36 Health Survey (SF-36), patient rating of pruritus, and patient global assessment of psoriasis.

RESULTS

At week 12, DLQI total score improved by 65-70% in patients receiving etanercept compared with 6% in patients receiving placebo (P < 0.0001), and improvement in DLQI was clinically meaningful (> or = 5-point improvement or 0 score) for 72-77% of patients receiving etanercept therapy. All DLQI and SF-36 subscales and the SF-36 physical and mental component summary scores demonstrated significantly greater improvement with etanercept therapy than with placebo, illustrating that etanercept benefits patients with psoriasis across multiple domains that contribute to health-related quality of life. With etanercept therapy, distributions of patient ratings of pruritus and global assessment of disease shifted from moderate to severe (baseline) to minimal to good (week 12). Etanercept-induced benefits of PROs were maintained for patients who reduced their dose after 12 weeks.

CONCLUSIONS

Etanercept therapy improves PROs in patients with psoriasis and makes a meaningful difference to their lives. These results support the efficacy profile of physician-reported clinical measures while providing a more complete understanding of the benefits experienced by patients with psoriasis treated with etanercept.

Authors+Show Affiliations

Krueger GG
Department of Dermatology, University of Utah Health Sciences Center, 30 N. 1900 E, Salt Lake City, UT 84132-0001, USA. krueger@derm.med.utah.edu
Langley RG
No affiliation info available
Finlay AY
No affiliation info available
Griffiths CE
No affiliation info available
Woolley JM
No affiliation info available
Lalla D
No affiliation info available
Jahreis A
No affiliation info available

MeSH

AdultDermatologic AgentsDouble-Blind MethodDrug Administration ScheduleEtanerceptFemaleHumansImmunoglobulin GImmunosuppressive AgentsMaleMiddle AgedPatient SatisfactionPruritusPsoriasisPsychometricsQuality of LifeReceptors, Tumor Necrosis FactorRecombinant Fusion ProteinsSeverity of Illness IndexTreatment Outcome

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16307657

Citation

Krueger, G G., et al. "Patient-reported Outcomes of Psoriasis Improvement With Etanercept Therapy: Results of a Randomized Phase III Trial." The British Journal of Dermatology, vol. 153, no. 6, 2005, pp. 1192-9.
Krueger GG, Langley RG, Finlay AY, et al. Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. Br J Dermatol. 2005;153(6):1192-9.
Krueger, G. G., Langley, R. G., Finlay, A. Y., Griffiths, C. E., Woolley, J. M., Lalla, D., & Jahreis, A. (2005). Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. The British Journal of Dermatology, 153(6), 1192-9.
Krueger GG, et al. Patient-reported Outcomes of Psoriasis Improvement With Etanercept Therapy: Results of a Randomized Phase III Trial. Br J Dermatol. 2005;153(6):1192-9. PubMed PMID: 16307657.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. AU - Krueger,G G, AU - Langley,R G, AU - Finlay,A Y, AU - Griffiths,C E M, AU - Woolley,J M, AU - Lalla,D, AU - Jahreis,A, PY - 2005/11/26/pubmed PY - 2006/2/14/medline PY - 2005/11/26/entrez SP - 1192 EP - 9 JF - The British journal of dermatology JO - Br J Dermatol VL - 153 IS - 6 N2 - BACKGROUND: Etanercept, a soluble tumour necrosis factor receptor, lessens the severity of psoriasis as measured by physician-reported clinical outcomes. Equally important is the patient perspective on the effect of etanercept therapy on daily life. OBJECTIVES: To assess patient-reported outcomes (PROs) in patients with psoriasis receiving etanercept therapy. METHODS: In this multinational, randomized, phase III trial, patients with psoriasis received placebo (n = 193), etanercept 50 mg per week (n = 196) or etanercept 50 mg twice weekly (n = 194) during the initial 12-week, double-blind period. Thereafter, all patients received open-label etanercept (50 mg per week). The following PROs were assessed: Dermatology Life Quality Index (DLQI), Short Form-36 Health Survey (SF-36), patient rating of pruritus, and patient global assessment of psoriasis. RESULTS: At week 12, DLQI total score improved by 65-70% in patients receiving etanercept compared with 6% in patients receiving placebo (P < 0.0001), and improvement in DLQI was clinically meaningful (> or = 5-point improvement or 0 score) for 72-77% of patients receiving etanercept therapy. All DLQI and SF-36 subscales and the SF-36 physical and mental component summary scores demonstrated significantly greater improvement with etanercept therapy than with placebo, illustrating that etanercept benefits patients with psoriasis across multiple domains that contribute to health-related quality of life. With etanercept therapy, distributions of patient ratings of pruritus and global assessment of disease shifted from moderate to severe (baseline) to minimal to good (week 12). Etanercept-induced benefits of PROs were maintained for patients who reduced their dose after 12 weeks. CONCLUSIONS: Etanercept therapy improves PROs in patients with psoriasis and makes a meaningful difference to their lives. These results support the efficacy profile of physician-reported clinical measures while providing a more complete understanding of the benefits experienced by patients with psoriasis treated with etanercept. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/16307657/Patient_reported_outcomes_of_psoriasis_improvement_with_etanercept_therapy:_results_of_a_randomized_phase_III_trial_ DB - PRIME DP - Unbound Medicine ER -