Pruritus is a common symptom of psoriasis. In many clinical trials of psoriasis treatments, severity of pruritus is a patient-reported outcome.
We sought to evaluate a patient-reported pruritus self-assessment tool using data from clinical trials of a tumor necrosis factor blocker.
The validity of the patient-reported 6-point pruritus assessment tool (0 = none to 5 = severe) was determined using data from a phase III trial of etanercept, a tumor necrosis factor blocker. The performance of the pruritus assessment tool was then evaluated using data from two large etanercept trials.
The pruritus assessment tool was validated and deemed to have good test-retest reliability (kappa coefficient = 0.71; 95% confidence interval = 0.62-0.80) and responsiveness (standardized response mean = 1.28; effect size = 1.63, responsiveness statistic = 1.54). Improvements in pruritus scores correlated with improvements in Psoriasis Area and Severity Index after 8 weeks of etanercept therapy in two phase III trials.
The pruritus assessment is validated only for patients with moderate to severe plaque psoriasis, and may not be applicable to other patient populations.
The pruritus assessment tool is a valid measurement of pruritus intensity in patients with moderate to severe plaque psoriasis and can discriminate between patients on and off treatment.Le texte complet de cet article est disponible en PDF.
Key words : assessment tool, etanercept, pruritus, psoriasis, quality of life, validation
Abbreviations used : BIW, HRQoL, PASI, PASI 50, TNF
| Research was funded by Immunex Corp, a wholly owned subsidiary of Amgen Inc, and by Wyeth Pharmaceuticals, which was acquired by Pfizer Inc in October 2009.
| Disclosure: Almost all of Dr Gottlieb’s consulting fees are paid to Tufts Medical Center. Dr Gottlieb has current consulting/advisory board agreements with Amgen Inc, Centocor Inc, Wyeth Pharmaceuticals, Celgene Corp, Bristol Myers Squibb Co, Beiersdorf Inc, Abbott, TEVA, Actelion, UCB, Novo Nordisk, Immune Control, Dermipsor Ltd, Incyte, Magen Biosciences, Cytokine Pharmasciences Inc, Alnylam, and Puretech. Tufts Medical Center has received research/educational grants from Centocor Inc, Amgen Inc, Wyeth Pharmaceuticals, Immune Control, Celgene Corp, Pharmacare, Incyte, Abbott, and Pfizer. Ms Feng, Dr Harrison, and Dr Globe are compensated employees and shareholders of Amgen Inc.