Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study

August 2017 | Volume 16 | Issue 8 | Original Article | 801 | Copyright © August 2017


Bruce Strober MD PhD,a Jerry Bagel MD,b Mark Lebwohl MD,c Linda Stein Gold MD,d J. Mark Jackson MD,e Rongdean Chen PhD,f* Joana Goncalves MD,f Eugenia Levi PharmD,f and Kristina Callis Duffin MD MSg

aUniversity of Connecticut, Farm ington, CT, and Probity Medical Research, Waterloo, Ontario, Canada bPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ cIcahn School of Medicine at Mount Sinai, New York, NY dHenry Ford Health System, West Bloomfield, MI eUniversity of Louisville, Forefront Dermatology, Louisville, KY fCelgene Corporation, Summit, NJ gUniversity of Utah, Salt Lake City, UT *Employed by Celgene Corporation at the time of study conduct.

Figure 2). Patient demographics and baseline disease characteristics were comparable between groups (Table 1). At baseline, mean psoriasis duration was 13.9 and 17.5 years in the placebo and apremilast groups, respectively. At baseline, mean BSA was 7.2%, mean PGAxBSA score was 21.8, mean pruritus VAS score was 56.6 mm, and mean DLQI score was 11.0; most patients (82%) reported prior treatment with topical therapy (Table 1). In addition, 76% of patients (n=167) had scalp disease (ScPGA ≥1) at baseline.

Efficacy Assessments

At week 16, the mean percentage change from baseline in PGAxBSA score (primary end point) was significantly greater with apremilast vs placebo (−48.1% vs −10.2%; P<0.0001) (Figure 3A; Table 2). At week 16, achievement of ≥75% reduction from baseline in PGAxBSA score (PGAxBSA-75) was significantly greater among patients receiving apremilast (35.1%) vs placebo (12.3%; P<0.0001) (Figure 3B; Table 2). An sPGA score of 0 (clear) or 1 (almost clear) at week 16 was achieved by significantly more patients receiving apremilast (30.4%) vs placebo (9.6%; P<0.0001) (Table 2); likewise, the proportion of patients achieving a PtGA score of 0 (clear) or 1 (very mild) at week 16 was significantly greater with apremilast (33.8%) vs placebo (20.5%; P=0.0365) (Table 2). Figure 3C shows a patient who achieved PGAxBSA-75 at week 16 while receiving apremilast. Mean percentage change from baseline in PASI score was significantly greater with apremilast (−40.72%) vs placebo (−3.87%; P<0.0001) at week 16. PASI-75 response was significantly greater among patients receiving apremilast (21.6%) vs placebo (8.2%; P=0.0136). Mean absolute change from baseline in PASI was −3.7 with apremilast vs 0.6 with placebo. Proportions of patients who achieved absolute PASI score ≤3 were 41.22% with apremilast vs 20.55% with placebo.

Other Efficacy End Points

Improvements were observed with apremilast vs placebo at week 16 in pruritus and scalp and nail disease (Table 2). Figure 4 illustrates improvement in scalp psoriasis typically seen at week 16 in a patient receiving apremilast.

Quality of Life Assessments

DLQI scores were significantly improved from baseline at week 16 in patients receiving apremilast (−4.8) vs placebo (−2.4; P=0.0008; Table 2); achievement of DLQI response (minimal clinically important difference [MCID], defined as decrease from baseline ≥5 points) was also significantly greater among patients with a DLQI score >5 at baseline receiving apremilast vs placebo (63.8% vs 34.5%; P=0.0009; Table 2). TSQM satisfaction scores at week 16 were significantly greater for patients receiving apremilast vs placebo in the Effectiveness and Global Satisfaction domains; no differences in TSQM scores were detected between groups in Convenience and Side Effects domains (Figure 5).

Safety

During the placebo-controlled period (weeks 0 to 16), 47.9% of patients receiving placebo and 62.6% receiving apremilast reported ≥1 AE (Table 3); most were mild or moderate. A total of 3 (2.0%) patients receiving apremilast experienced 4 serious AEs; no serious AEs occurred in patients receiving placebo. Serious AEs among apremilast patients included pyelonephritis and nephrolithiasis (both n=1), and cholelithiasis (n=1). A 62-year-old man with medical history of type 2 diabetes mellitus, hyperlipidemia, and peripheral arterial disease had a cerebrovascular accident. No serious AEs were considered treatment related. Discontinuation rates due to AEs were low in both groups (Table 3). Table 1