Efficacy and safety of apremilast in patients with moderate plaque psoriasis (UNVEIL phase 4 study)
Strober B, Bagel J, Lebwohl JM, Stein Gold L, Jackson JM, Chen R, Levi E, Duffin KC. Efficacy and safety of apremilast in patients with moderate plaque psoriasis (UNVEIL phase 4 study). Journal of the American Academy of Dermatology 2017; 76(6):AB111-AB111.
Journal of the American Academy of Dermatology
Introduction and Objectives: Patients (pts) with moderate plaque psoriasis are often inadequately treated (Armstrong, 2013), and there remains an unmet medical need for an effective and convenient treatment option in this population. UNVEIL is the first prospective RCT that has evaluated the clinical efficacy and safety of a systemic treatment, oral apremilast (APR), in pts with moderate plaque psoriasis with body surface area (BSA) involvement of 5-10% who are naïve to systemic and biologic therapy.
Methods and Materials: 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. The primary efficacy endpoint was the mean percentage change from baseline in the product of BSA and sPGA (PGAxBSA) at week 16. Scalp psoriasis was assessed with Scalp Physician Global Assessment (ScPGA).
Results: 221 pts were randomized (PBO = 73, APR30 = 148). At baseline, mean BSA was 7%, PGAxBSA was 21.7, Psoriasis Area and Severity Index (PASI) was 8.1, and over 80% of pts were on topical therapy prior to enrollment. Pts who received APR30 had a mean 48.1% improvement in PGAxBSA vs 10.2% in PBO group at week 16 ( P < .0001). Additionally, 35% of APR30 pts achieved at least 75% improvement in PGAxBSA from baseline (PGAxBSA-75) relative to 12.3% of PBO pts ( P = .0136). Significantly more APR30 pts achieved a score of 0 (clear) or 1 (almost clear) on sPGA at week 16 compared to PBO (30.4% vs 9.6%; P < .0001). Over 75% (n = 167) of enrolled pts presented with psoriasis of the scalp and significantly more pts treated with APR30 were clear or almost clear (ScPGA = 0 or 1) with a 2-point improvement on ScPGA relative to PBO (38.0% vs 20.0%, P= .0178). The majority of adverse events (AEs) were mild to moderate in severity. The most common AEs occurring in ≥5% of pts in either treatment group were diarrhea, headache, nausea, upper respiratory tract infection, decreased appetite, and vomiting.
Conclusions: Apremilast is effective in the systemic naïve, post-topical moderate plaque psoriasis pts. Safety and tolerability were consistent with other published studies.
Commercial support: The research study and the analysis supported by Celgene.