Table 1.
Prespecified endpoint/analysis | Post hoc endpoint/analysis |
---|---|
Dermatologic | |
Dermatologic‐related PROs | |
|
BSA, body surface area; DLQI, Dermatology Life Quality Index; ISI, Itch Severity Item; LSM, least squares mean; MCID, minimum clinically important difference; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PASI75, improvements from baseline in PASI ≥75%; PASI90, improvements from baseline in PASI ≥90%; PGA‐PsO, Physician’s Global Assessment of Psoriasis; PGJS‐VAS‐PsO, Patient’s Global Joint and Skin Assessment‐Visual Analog Scale‐Psoriasis question; PRO, patient‐reported outcome.
Among patients with baseline BSA ≥3% and baseline PASI >0.
As stratified by baseline PASI >0 to ≤10 (mild) or baseline PASI >10 (moderate–severe).
Among patients with baseline PGA‐PsO >0.
Among patients with baseline NAPSI >0 (based on one target fingernail affected).
Percentage of patients achieving PGA‐PsO response, defined as a score of 0 (clear)/1 (almost clear) on a 0–4 scale and ≥2‐point improvement from baseline in patients with baseline PGA‐PsO ≥2.
DLQI total score ranges from 0 to 30, with a higher score indicating greater impact on quality of life. 23
Among patients with baseline ISI >0. Scores range from 0–10, where 0 = no itching and 10 = worst possible itching. 14
DLQI question #1 on skin symptoms: ‘Over the last week, how itchy, sore, painful or stinging has your skin been?’. 23
Patients were asked to place a mark on a 0–100 mm line to indicate their response to the question ‘In all the ways your psoriasis affects you, how would you rate the way in which you felt over the past week?’ (0 = excellent and 100 = poor).
Defined as improvement from baseline ≥5 points 24 among patients with baseline DLQI total score >0, BSA ≥3% and PASI >0.
Based on improvements from baseline of ≥2, ≥3 or ≥4, among patients with baseline ISI >0.