The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials

The Journal of Dermatological Treatment
R G LangleyC Papavassilis

Abstract

To evaluate new psoriasis treatments, clinicians, regulators and pharmaceutical developers require well-accepted, clinically meaningful measures of disease severity. The Psoriasis Area and Severity Index (PASI) score is most widely used as a primary endpoint in clinical trials, although it is not routinely used in clinical practice. Characterize a 5-point Investigator's Global Assessment (IGA) tool and evaluate whether it meets the needs for a valid, clinically meaningful measure. A 5-point IGA tool was developed with input from regulatory authorities and clinical trial investigators involved with psoriasis drug development and evaluation. Associations between IGA 0/1 responder rates and PASI scores were evaluated using data from two phase 2 studies with the anti-interleukin (IL)-17A monoclonal antibody secukinumab (AIN457) that utilized a similar 6-point IGA. The 5-point IGA has a more stringent definition for a score of 1 ("almost clear") compared with 6-point IGA/Physician's Global Assessment (PGA) tools used in previous trials of other biologics in moderate-to-severe psoriasis. Whereas IGA/PGA 0/1 responder rates for earlier scales are strongly associated with PASI 75, the IGA 0/1 rate for the secukinumab 6-point scale was ...Continue Reading

Associated Clinical Trials

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Oct 9, 2015·The Journal of Dermatological Treatment·Steven R FeldmanHema N Viswanathan
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