Safe psoriasis control: a new outcome measure for the composite assessment of the efficacy and safety of psoriasis treatment.
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.


CONCLUSIONS
The SPC endpoint may be a step-forward in providing a composite tool for the evaluation of treatments for psoriasis.
Papp
Kim A
KA
Probity Medical Research, Waterloo, Ontario, Canada.
Henninger
Eric
E
D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic; D017326:Clinical Trials, Phase III as Topic; D003627:Data Interpretation, Statistical; D006801:Humans; D011565:Psoriasis / Q000188:drug therapy / Q000628:therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012449:Safety; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C472181:efalizumab