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CDISC would appreciate supplement reviewer’s input on their experience in using the Psoriasis Area and Severity Index instrument regarding what responses are being used for symptoms "erythema/redness", "thickness/induration" and "desquamation/scaling". There are 3 possible references that were found to explain PASI:

• Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65–ii68.
  • Responses for symptoms are: none, slight, mild, moderate, severe.
• Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839. PMID: 357213.
  • Responses for symptoms are: none, slight, moderate, striking, exceptionally striking.
• EMA guideline on Clinical Investigation of Medicinal Products Indicated for the Treatment of Psoriasis (https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-indicated-treatment-psoriasis_en.pdf)
  • Responses for symptoms are based off Fredriksson (no symptoms, slight, moderate, marked, very marked) and are grouped as: mild to moderate, moderate, moderate to severe and severe. 

CDISC would appreciate reviewer help regarding which list of responses are used (those that mirror Feldman, Fredriksson, EMA or some other combination.

If the responses list is not in a majority (per public comment), it will be considered “undetermined”. The supplement will allow a sponsor’s list of responses, like the CDISC published in the PGI and CGI supplements.