Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary: A Secondary Analysis of a Randomized Clinical Trial.

ABSTRACT:

Importance

Change from baseline score on the validated Psoriasis Symptoms and Signs Diary (PSSD) is a widely used, patient-reported end point in clinical trials for psoriasis. Meaningful score change thresholds anchored to patient-reported assessments have not been established in a clinical trial setting.

Objective

To evaluate meaningful within-patient score change thresholds for the PSSD using data from the phase 3 Program to Evaluate the Efficacy and Safety of Deucravacitinib, a Selective TYK2 Inhibitor (POETYK), PSO-1 clinical trial, which compared the efficacy and safety of deucravacitinib vs placebo and apremilast among adults with moderate to severe plaque psoriasis.

Design, setting, and participants

In this predefined analysis using data from the POETYK PSO-1 m

SUBMITTER: Papp KA 

PROVIDER: S-EPMC10733845 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature