BACKGROUND: PASI is an inadequate outcome measure for the assessment of psoriasis treatments. No currently used endpoints provide a benefit: risk assessment of treatment taking into consideration all available efficacy and safety data. OBJECTIVE: To propose a new outcome measure called "safe psoriasis control" (SPC), which assesses multiple dimensions of the disease in a clinically meaningful way through the combined use of appropriate efficacy, quality of life, and safety data. METHODS: Data from 3,500 subjects were used for the purpose of derivation and validation of the SPC endpoint. Advanced statistical methodology was used to evaluate and validate important components in the assessment of therapeutic benefit. RESULTS: SPC was shown to be a simple but meaningful combined endpoint showing the proportion of patients who had treatment benefit without major side effects. CONCLUSION: The SPC endpoint may be a step-forward in providing a composite tool for the evaluation of treatments for psoriasis.
BACKGROUND: PASI is an inadequate outcome measure for the assessment of psoriasis treatments. No currently used endpoints provide a benefit: risk assessment of treatment taking into consideration all available efficacy and safety data. OBJECTIVE: To propose a new outcome measure called "safe psoriasis control" (SPC), which assesses multiple dimensions of the disease in a clinically meaningful way through the combined use of appropriate efficacy, quality of life, and safety data. METHODS: Data from 3,500 subjects were used for the purpose of derivation and validation of the SPC endpoint. Advanced statistical methodology was used to evaluate and validate important components in the assessment of therapeutic benefit. RESULTS: SPC was shown to be a simple but meaningful combined endpoint showing the proportion of patients who had treatment benefit without major side effects. CONCLUSION: The SPC endpoint may be a step-forward in providing a composite tool for the evaluation of treatments for psoriasis.
Authors: Fernando M Stengel; Valeria Petri; Gladys Am Campbell; Gladys Leon Dorantes; Magdalina López; Ricardo L Galimberti; Raúl P Valdez; Lucia F de Arruda; Mario Amaya Guerra; Edgardo N Chouela; Daiana Licu Journal: Arch Drug Inf Date: 2009-12