Why carry out this study?

The clinical manifestations of plaque psoriasis have been shown to severely impact patients’ quality of life and emotional well-being; therefore, it is important to measure patient experience alongside clinical parameters in the evaluation of treatments for plaque psoriasis.

The Psoriasis Symptoms and Impacts Measure (P-SIM) is a novel, patient-reported outcome tool developed to specifically capture patients’ experiences of the key signs, symptoms and impacts of plaque psoriasis; here, it was completed daily by patients at home on a handheld device on a 0–10 numeric rating scale, and item scores were derived as averages of daily scores over a week.

In these analyses, the psychometric properties of the P-SIM were evaluated using data pooled from the first 16 weeks of the BE VIVID and BE READY phase 3 trials investigating bimekizumab in the treatment of moderate to severe plaque psoriasis.

What was learned from this study?

In these analyses, the 14 item scores of the P-SIM demonstrated good reliability, validity and sensitivity to change in the assessment of patients’ experiences of key psoriasis signs, symptoms and impacts when completed daily on a handheld device over a period of 16 weeks.

Anchor-based analyses determined a 4-point decrease in item scores of the P-SIM as indicative of a marked clinically meaningful improvement when the P-SIM was completed daily on a handheld device; this threshold can be used to assess treatment effects over 16 weeks in patients with moderate to severe plaque psoriasis.