Validation and response to treatment of a pruritus self-assessment tool in patients with moderate to severe psoriasis.
BACKGROUND
Pruritus is a common symptom of psoriasis. In many clinical trials of psoriasis treatments, severity of pruritus is a patient-reported outcome.


OBJECTIVE
We sought to evaluate a patient-reported pruritus self-assessment tool using data from clinical trials of a tumor necrosis factor blocker.


METHODS
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.


RESULTS
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.


CONCLUSIONS
The pruritus assessment is validated only for patients with moderate to severe plaque psoriasis, and may not be applicable to other patient populations.


CONCLUSIONS
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.
Gottlieb
Alice
A
Tufts Medical Center, Boston, Massachusetts 02111-1533, USA. agottlieb@tuftsmedicalcenter.org
Feng
Jingyuan
J
Harrison
David J
DJ
Globe
Denise
D
D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000068800:Etanercept; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000209:etiology* / Q000503:physiopathology; D011565:Psoriasis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012647:Self-Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept