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
Lebwohl M, Jackson J, Bagel J, Levi E, Weaver J, Stein Gold LF, Alikhan A, Forman S, Lockshin B, Duffin K. 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. Journal of the American Academy of Dermatology 2018; 79(3):AB138.
Journal of the American Academy of Dermatology
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%).