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. 2020 Jul 16;34(12):2809–2820. doi: 10.1111/jdv.16433

Table 1.

Prespecified and post hoc dermatologic and dermatology‐related PRO endpoints included in the analysis

Prespecified endpoint/analysis Post hoc endpoint/analysis
Dermatologic
  • LSM percentage change from baseline in PASI total score
  • LSM change from baseline in PGA‐PsO §
  • LSM change from baseline in NAPSI
  • Percentage of patients with PASI90
  • PASI75 and PASI90 by baseline PASI severity ,
  • LSM change from baseline in PASI total score
  • Percentage of patients achieving PGA‐PsO response ††
Dermatologic‐related PROs
  • LSM change from baseline in DLQI total score ‡‡
  • LSM change from baseline in ISI §§
  • LSM change from baseline in PGJS‐VAS‐PsO †††
  • LSM change from baseline in DLQI total score among patients with baseline BSA ≥3% and baseline PASI >0 ‡‡
  • LSM change from baseline in DLQI sub‐dimensions
  • LSM change from baseline in DLQI question on skin symptoms ¶¶
  • Percentage of patients achieving MCID for improvement from baseline in DLQI ‡‡‡
  • Percentage of ISI responders §§§
  • Percentage of patients with ≥30%, ≥50% or ≥70% improvement from baseline in PGJS‐VAS‐PsO †††

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.