Efficacy of apremilast on quality of life measures in patients with moderate plaque psoriasis (UNVEIL phase 4 study)
Bagel J, Lebwohl MG, Stein Gold L, Jackson J, Chen R, Goncalves J, Duffin K, Strober B. Efficacy of apremilast on quality of life measures in patients with moderate plaque psoriasis (UNVEIL phase 4 study). Journal of the American Academy of Dermatology 2017; 76(6 Suppl 1):AB119.
Journal of the American Academy of Dermatology
Purpose: UNVEIL is the first prospective randomized controlled trial that has evaluated the clinical efficacy and safety of a systemic treatment, oral apremilast (APR), focusing only on patients (pts) with moderate plaque psoriasis with body surface area (BSA) involvement of 5-10% and who have not been exposed to systemic and biologic therapy. Effect of APR on patients’ symptoms, quality of life (QoL) and satisfaction with treatment were measured along with efficacy and safety.
Methods: Pts with chronic plaque psoriasis having a BSA of 5-10% and a static Physicians Global Assessment (sPGA) of 3 (moderate, 0-5 scale) with no prior exposure to systemic treatments or biologics, were randomized (2:1) to APR 30 mg BID (APR30) or placebo (PBO) for 16 weeks. QoL was assessed using the Dermatology Life Quality Index (DLQI) score (0-30, 30 = worst QoL), the Treatment Satisfaction Questionnaire for Medication (TSQM) Version II score (0-100, 0 = worst; measures treatment effectiveness, side effects, convenience, global satisfaction), and the Pruritus Visual Analog Scale (VAS) (0-100 mm, 100 = worst itch) to measure pruritus.
Results: 221 pts with moderate plaque psoriasis were randomized (PBO = 73, APR30 = 148). At baseline (BL), mean BSA was 7%, Psoriasis Area and Severity Index (PASI) was 8.1, DLQI was 11, Pruritus VAS was 56.6 mm, and over 80% of pts were on topical therapy prior to enrollment. Significantly more pts treated with APR30 experienced at least 5-point improvement in DLQI score (MCID) compared to PBO (50.7% vs 27.4% P = .0025). Mean TSQM scores were significantly improved with APR30 relative to PBO for global satisfaction (63.2 vs 48.7, P < .0001) and for treatment effectiveness (57.3 vs 38.8, P < .0001), while convenience and side effects scores were not significantly different between PBO and APR30 groups. Pts treated with APR30 reported greater improvement in pruritus as measured by mean change in Pruritus VAS score from BL at 16 weeks (APR30: -19.2 mm; PBO: -10.2 mm, P = .002).
Conclusion: Apremilast significantly improved QoL and pruritus in systemic naïve, post-topical moderate plaque psoriasis patients. Patients reported satisfaction with effectiveness, safety, and convenience of apremilast.
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