The following is a summary of “Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary,” published in the December 2023 issue of Dermatology by Papp, et al.

For a study, researchers sought to determine meaningful within-patient score change thresholds for the Psoriasis Symptoms and Signs Diary (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.

The predefined analysis utilized data from the POETYK PSO-1 multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial conducted from August 7, 2018, to September 2, 2020. About 666 adults with moderate to severe plaque psoriasis completed the PSSD daily throughout the trial. Meaningful change thresholds were derived by correlating mean PSSD score change from baseline to week 16 with category improvements on the Patient Global Impression of Change (PGI-C) and the Patient Global Impression of Severity (PGI-S). Participants were administered deucravacitinib, 6 mg, once daily; placebo; or apremilast, 30 mg, twice daily. The main outcome measure was the score change from baseline to week 16 on the PSSD, anchored to the PGI-C and PGI-S.

The trial cohort comprised 666 patients (mean [SD] age, 46.1 [13.4] years; 453 men [68.0%]). Three thresholds were identified from an analysis set of 609 patients. A score improvement of at least 15 points from baseline indicated meaningful within-patient change, anchored to the PGI-C. Score improvements of 25 points were supported by both the PGI-C and the PGI-S, while a 30-point score change identified patients with greater improvements in their psoriasis symptoms and signs.

The analysis suggested that PSSD score improvements of 15, 25, or 30 points represent increasing improvements in disease burden that are meaningful to patients with psoriasis.

Reference: jamanetwork.com/journals/jamadermatology/fullarticle/2812733