Title

Examining disease severity and symptom improvement with patient and physician assessments: Results from a phase IV analysis of apremilast in patients with moderate plaque psoriasis

Document Type

Conference Proceeding

Publication Date

9-2018

Publication Title

Journal of the American Academy of Dermatology

Abstract

Background: UNVEIL is the first study of apremilast in patients (pts) with moderate psoriasis (body surface area [BSA] 5%-10%) naive to biologic and systemic therapy. Physician and pt evaluations help determine treatment effectiveness. Improvements on physician and pt assessments over 52 wks are described.

Methods: Patients with chronic moderate plaque psoriasis (BSA 5%-10%; Static Physician’s Global Assessment [sPGA] score 3 [0-5 scale]) were randomized (2:1) to apremilast 30 mg bid (APR) or placebo (PBO) for 16 wks. Pts continued APR (APR/APR) or switched from PBO to APR (PBO/APR) through wk 52 (open-label treatment phase). Physician assessments were the product of sPGA and BSA (PGA×BSA), proportion of pts who achieved sPGA response (score of 0 [clear] or 1 [almost clear]), and PGA×BSA-75 response (≥75% improvement from baseline [BL]). Pt assessments were Dermatology Life Quality Index (DLQI), pruritus VAS (0-100 mm), Treatment Satisfaction Questionnaire for Medication (TSQM), and Pt’s Global Assessment (PtGA [0-4 scale]).

Results: In randomized pts (PBO n = 73; APR n = 148), mean BL BSA was 7.2%, PGA×BSA was 21.8DLQI was 11.0, and pruritus VAS was 56.6 mm. At wk 16, APR showed greater mean improvement in PGA×BSA vs. PBO (−48.1% vs. −10.2%; P < .0001), and more pts achieved sPGA response and PGA×BSA-75 with APR vs. PBO (30.4% vs. 9.6% and 35.1% vs. 12.3%, respectively). Achievement of DLQI response (≥5-point decrease from BL in pts with BL DLQI >5) was greater with APR at wk 16 vs. PBO (63.8% vs. 34.5%), as was pruritus VAS response (improvement ≥20%: 62.8% vs. 45.2%) and TSQM global satisfaction (63.2 vs. 48.7) and effectiveness (57.3 vs. 38.8). PtGA ≤1 was achieved by more pts receiving APR vs. PBO (33.8% vs. 20.5%). At wk 52, changes in PGA×BSA were −42.2% (PBO/APR) and −55.5% (APR/APR); 45.3% (PBO/APR) and 42.1% (APR/APR) of pts achieved PGA×BSA-75, 35.9% (PBO/APR) and 33.1% (APR/APR) achieved sPGA response, 55.6% (PBO/APR) and 59.4% (APR/APR) achieved DLQI response, and 68.8% (PBO/APR) and 66.9% (APR/APR) achieved pruritus VAS response. TSQM global satisfaction (PBO/APR 59.2; APR/APR 59.9) and effectiveness (PBO/APR 57.7; APR/APR 54.1) scores were similar between treatment groups at wk 52; 42.2% (PBO/APR) vs. 37.2% (APR/APR) had PtGA ≤1. No new safety/tolerability issues emerged.

Conclusion: Physician and pt assessments showed improvement with APR up to 52 wks in biologic- and systemic-naive pts with moderate psoriasis (BSA 5%-10%).

Volume

79

Issue

3

First Page

AB138

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