Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL
February 2018 | Volume 17 | Issue 2 | Original Article | 221 | Copyright © February 2018
Linda Stein Gold MD,a Jerry Bagel MD,b Mark Lebwohl MD,c J. Mark Jackson MD,d Rongdean Chen PhD,e Joana Goncalves MD,e Eugenia Levi PharmD,e Kristina Callis Duffin MD MSf
aHenry Ford Health System, West Bloomfield, MI bPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ cIcahn School of Medicine at Mount Sinai, New York, NY dUniversity of Louisville, Forefront Dermatology, Louisville, KY eCelgene Corporation, Summit, NJ fUniversity of Utah, Salt Lake City, UT
Abstract
BACKGROUND: Many patients with moderate plaque psoriasis are undertreated despite broadening treatment options. In the phase IV UNVEIL study, oral apremilast demonstrated efficacy and safety in systemic-naive patients with chronic moderate plaque psoriasis with lower psoriasis-involved body surface area (BSA; 5%–10%) during the 16-week, double-blind, placebo-controlled phase. We describe efficacy and safety of apremilast in this population through week 52 in UNVEIL.
METHODS: Patients with moderate plaque psoriasis (BSA 5%–10%; static Physician’s Global Assessment [sPGA] score of 3 [moderate]) and naive to systemic therapies for psoriasis were randomized (2:1) to receive apremilast 30 mg twice daily or placebo for 16 weeks. At week 16, patients continued on apremilast (apremilast/apremilast) or were switched from placebo to apremilast (placebo/apremilast) through week 52 (open-label apremilast treatment phase). Efficacy assessments included the product of sPGA and BSA (PGAxBSA) (mean percentage change from baseline; ≥75% reduction from baseline [PGAxBSA-75]), sPGA response (achievement of score of 0 [clear] or 1 [almost clear]), and the Dermatology Life Quality Index (DLQI; mean change from baseline).
RESULTS: A total of 136 patients completed the 52-week analysis period (placebo/apremilast, n=50/64; apremilast/apremilast, n=86/121). At week 52, improvements in all efficacy end points observed at week 16 were maintained in the apremilast/apremilast group (mean percentage change from baseline in PGAxBSA: −55.5%; PGAxBSA-75: 42.1%; sPGA response: 33.1%; mean change from baseline in DLQI score: −4.4); similar improvements emerged in the placebo/apremilast group after switching to apremilast. The most common adverse events (≥5% of patients) through week 52 were diarrhea (28.0%), nausea (19.0%), headache (15.2%), nasopharyngitis (10.4%), upper respiratory tract infection (7.1%), vomiting (5.7%), and decreased appetite (5.2%).
CONCLUSIONS: Apremilast was effective in systemic-naive patients with moderate plaque psoriasis with BSA 5%–10%; efficacy was sustained through week 52. No new safety signals emerged with continued apremilast exposure.
ClinicalTrials.gov: NCT02425826
J Drugs Dermatol. 2018;17(2):221-228.
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Introduction
Recently, the treatment landscape in plaque psoriasis has broadened substantially, with the availability of new oral, topical, and biologic options.1-3 However, many patients with moderate psoriasis (5% to 10% psoriasis-involved body surface area [BSA])4 receive no treatment or are undertreated with topical monotherapy5,6 because physicians may consider conventional systemic treatments or biologic agents inappropriate for management of moderate psoriasis, based on the risk-benefit profile.7Apremilast is an oral, small-molecule phosphodiesterase 4 inhibitor that demonstrated efficacy and a favorable safety and tolerability profile in phase III studies in patients with moderate to severe psoriasis.8,9 The Evaluating Apremilast in a Phase IV Trial of Efficacy and Safety in Patients With Moderate Plaque Psoriasis (UNVEIL) study investigated the effects of apremilast in patients with moderate plaque psoriasis, defined as 5% to 10% BSA involvement and static Physician’s Global Assessment (sPGA) score of 3 (moderate) on a 6-point scale, who were naive to systemic and biologic therapy.10 Week 16 results demonstrated apremilast was effective in this new population; the primary efficacy end point, mean percentage change in the product of sPGA and BSA score (PGAxBSA), was met.10 Apremilast was well tolerated and significantly improved quality of life (QOL).10 Patients treated with
