INTRODUCTION
• Patients with moderate plaque psoriasis (i.e., 5% to 10% psoriasis-involved body surface area [BSA]1) often receive no 

treatment or are undertreated with topical monotherapy.2,3

• Patients with moderate psoriasis often report substantial impairments in disease-related quality of life (QOL), despite having 
lower psoriasis-involved BSA.3

• Among the symptoms of psoriasis, pruritus is a key contributor to QOL impairments.4

• Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor,5 improved QOL and disease severity, with acceptable 
tolerability, in phase III clinical studies of patients with moderate to severe psoriasis.6-8

• Evaluating Apremilast in a Phase IV Trial of Effi cacy and Safety in Patients With Moderate Plaque Psoriasis (UNVEIL; ClinicalTrials.
gov: NCT02425826), the fi rst prospective, randomized, placebo (PBO)-controlled trial in systemic- and biologic-naive patients with 
moderate plaque psoriasis, demonstrated that apremilast 30 mg twice daily (APR) was effective, generally well tolerated, and had 
a positive impact on QOL during the 16-week, double-blind, PBO-controlled phase.

• The improvements in QOL and pruritus as well as treatment satisfaction are described for the open-label APR treatment phase 
(Weeks 16 to 52) of UNVEIL.

METHODS
Patients
Key Inclusion Criteria
• Males or females ≥18 years of age

• Chronic plaque psoriasis for ≥6 months before screening

• Moderate plaque psoriasis at screening and baseline as defi ned by BSA of 5% to 10% and static Physician’s Global Assessment 
(sPGA) of 3 (moderate) based on a scale ranging from 0 (clear) to 5 (very severe)

• No prior exposure to systemic or biologic treatments for psoriasis, psoriatic arthritis, or any other condition that could affect the 
assessment of psoriasis 

Key Exclusion Criteria
• Infl ammatory or dermatologic condition, including forms of psoriasis other than plaque psoriasis

• Topical therapy within 2 weeks or phototherapy within 4 weeks of randomization

Study Design
• UNVEIL is a phase IV, multicenter, randomized, PBO-controlled, double-blind study (Figure 1).

• Patients were randomized (2:1) to receive APR or PBO during Weeks 0 to 16; patients in the PBO group were switched to APR at 
Week 16.

• All patients continued taking APR through Week 52.

• An unmedicated moisturizer was the only topical therapy permitted during the study.

Figure 1. UNVEIL Study Design

Figure 2

DLQI 
Pruritus VAS

Apremilast 30 mg BID

Apremilast 30 mg BID‡Placebo

Placebo-Controlled 
Phase

Open-label 
Treatment Phase 

Safety 
Observation

‒5 Weeks Week 16 Week 52Week 0 Week 56

SCREEN*

DLQI 
Pruritus VAS

TSQM

DLQI 
Pruritus VAS

TSQM

RA
N

D
O

M
IZ

E
1:

2§

ClinicalTrials.gov: NCT02425826 
*Screening up to 35 days before randomization.
§All doses were titrated over the fi rst week of treatment.
‡At Week 16, all placebo patients were switched to open-label apremilast 30 mg BID (with dose titration) through Week 52.
BID=twice daily.

METHODS (cont’d)
QOL, Pruritus, and Treatment Satisfaction Assessments
• Patients completed the Dermatology Life Quality Index (DLQI), pruritus visual analog scale (VAS), and Treatment Satisfaction 

Questionnaire for Medication (TSQM) version II.

QOL
• QOL was assessed with the DLQI, a validated instrument that consists of 10 items pertaining to the skin and designed to 

assess QOL in a dermatology clinical setting.9

• QOL end points:
 – Mean change from baseline in DLQI total score at Week 16 and Week 52 
 – Proportion of patients with baseline DLQI >5 who achieved DLQI response (i.e., minimal clinically important difference 

[MCID], defi ned as ≥5-point improvement from baseline in DLQI total score among patients with baseline DLQI >5).

Pruritus
• Pruritus was assessed on a 100-mm VAS ranging from “no itch” (0) to “itch as severe as can be imagined” (100).

• Pruritus end points included mean change from baseline in pruritus VAS at Week 16 and Week 52. 

Treatment Satisfaction
• Treatment satisfaction was assessed using the TSQM version II, a validated, self-administered, 11-question instrument 

designed to evaluate patient satisfaction with current treatment.10

 – An algorithm is used to transform scores to a 0 to 100 scale for effectiveness, side effects, convenience, and global 
satisfaction, with higher scores indicating greater satisfaction.

 – Mean TSQM scores for effectiveness, side effects, convenience, and global satisfaction were assessed at Week 16 and Week 52. 

Safety Assessments
• Safety was evaluated based on adverse events (AEs), vital signs, clinical laboratory testing, and complete physical examinations.

Statistical Analysis
• QOL, pruritus, and treatment satisfaction assessments were conducted for the intent-to-treat population, which included all 

randomized patients; safety assessments were conducted in all randomized patients who received ≥1 dose of study medication.

• Changes from baseline in DLQI total score and pruritus VAS score at Week 16 were compared between the APR and PBO groups 
using a 2-way analysis of covariance (ANCOVA) model with treatment and site as factors and baseline value as a covariate.

• The proportions of patients achieving a DLQI response at Week 16 were compared between groups using a 2-sided 
Cochran-Mantel-Haenszel test stratifi ed by site.

• Mean TSQM scores at Week 16 were compared between treatment groups by 2-way analysis of variance (ANOVA) with 
treatment and site as factors.

• QOL, pruritus, and treatment satisfaction parameters at Week 52 were evaluated descriptively.

• The last-observation-carried-forward (LOCF) methodology was used to impute missing values.

• Safety assessments were summarized using frequencies and percentages.

RESULTS
Patients
• A total of 221 patients were randomized to study treatment and constitute the intent-to-treat population; 185 patients (84%) 

completed the PBO-controlled phase (Weeks 0 to 16) and 136/185 patients (74%) completed the APR treatment phase 
(Weeks 16 to 52).

• Demographics and baseline disease characteristics were generally similar between treatment groups (Table 1).
 – At baseline, mean DLQI total scores were comparable between treatment groups, and mean pruritus VAS score was slightly 

higher in the PBO group. 

Table 1. Patient Demographics and Baseline Disease Characteristics 

Characteristic
PBO
n=73

APR
n=148

Age, mean (SD), years 51.1 (13.7) 48.6 (15.4)

Male, n (%) 41 (56.2) 74 (50.0)

Body mass index, mean (SD), kg/m2 30.8 (6.5) 30.5 (7.4)

Duration of psoriasis, mean (SD), years 13.9 (12.6) 17.5 (13.9)

BSA, mean (SD), % 7.1 (1.8) 7.2 (1.6)

sPGA score=3 (moderate)*, n (%) 70 (95.9) 144 (97.3)

DLQI total score, mean (SD) 11.1 (6.5) 11.0 (6.5)

Pruritus VAS score, mean (SD), mm 60.0 (22.5) 55.0 (24.3)

PASI score (0–72), mean (SD) 8.0 (3.2) 8.2 (4.0)
*Although the inclusion criterion was sPGA=3, patients with sPGA=4 were enrolled in error (n=4).
PASI=Psoriasis Area and Severity Index.

RESULTS (cont’d)
Effect of APR on QOL
• At Week 16, improvement from baseline in DLQI total score was signifi cantly greater with APR than with PBO (−4.8 vs. −2.4; 

P=0.0008) (Figure 2). 
• Signifi cantly more patients with a baseline DLQI total score >5 who received APR vs. PBO achieved the DLQI MCID at Week 16 

(63.8% vs. 34.5%; P=0.0009) (Figure 3).
• At Week 52, improvement in the DLQI total score was maintained in patients who were randomized to APR and then continued 

on APR during the open-label APR treatment phase (mean change from baseline: −4.4).

• Patients who switched from PBO to APR at Week 16 achieved similar improvements in DLQI total score at Week 52 (mean 
change from baseline: −5.1) (Figure 2). 

• Among patients who were initially randomized to APR at baseline, the percentage of patients who achieved DLQI MCID at 
Week 16 was maintained over 52 weeks (Figure 3).

Figure 2. Improvements in DLQI Total Score 

–8

–7

–6

–5

–4

–3

–2

–1

0

PBO
n=73

APR
n=148

PBO/APR
n=64

APR/APR
n=121

Week 16 Week 52

–2.4

−4.8

−5.1

−4.4
M

ea
n 

Ch
an

ge
 F

ro
m

 B
as

el
in

e
in

 D
LQ

I T
ot

al
 S

co
re

*

*P=0.0008 vs. PBO. Error bars represent 95% confi dence intervals (CIs).

Figure 3. Proportion of Patients Achieving DLQI Response 

0

10

20

30

40

50

60

70

80

PBO
n=58

APR
n=116

PBO/APR
n=54

APR/APR
n=96

Week 16 Week 52

34.5

63.8
55.6 59.4

Pa
tie

nt
s 

Ac
hi

ev
in

g 
D

LQ
I M

CI
D

 (%
)

*

*P=0.0009 vs. PBO. Error bars represent 95% CIs.

Effect of APR on Pruritus VAS
• At Week 16, mean change from baseline in pruritus VAS score was −19.2 mm in the APR group and −10.2 mm in the PBO 

group (P=0.0016) (Figure 4).
• The improvement in pruritus VAS was maintained at Week 52 in patients who continued on APR, and mean VAS scores 

improved in those switched from PBO to APR (Figure 4).

RESULTS (cont’d)

Figure 4. Improvement in Pruritus VAS Score 

–50

–40

–30

–20

–10

0

PBO

M
ea

n 
Ch

an
ge

 F
ro

m
 B

as
el

in
e

in
 P

ru
ri

tu
s 

VA
S,

 m
m

PBO and PBO/APR, n 69 68 59 61 57 55 50 44 39

APR and APR/APR, n 139 136 121 119 106 97 84 71 62
Week 1 4 12 16 20 24 32 42 52

Week

1 4 12 16 24 5232 42200

APR/APR
PBO/APRPBO/APR

LOCF
–25.3

APR/APR
LOCF
–20.8

As-observed analysis. Error bars represent 95% CIs.

Treatment Satisfaction
• At Week 16, treatment effectiveness, as measured by the TSQM, was signifi cantly greater with APR than with PBO (P<0.0001). 

Global satisfaction also favored APR over PBO (P<0.0001), whereas satisfaction with side effects (P=0.34) and convenience 
(P=0.63) did not differ between treatment groups (Figure 5).

• At Week 52, levels of satisfaction were maintained on all domains (Figure 5). 

Figure 5. Treatment Satisfaction Measured Using the TSQM 

M
ea

n 
TS

QM
 S

co
re

Gr
ea

te
r S

at
is

fa
ct

io
n

M
ea

n 
TS

QM
 S

co
re

Gr
ea

te
r S

at
is

fa
ct

io
n

Week 52

75.0
65.7

78.5
66.9

77.3
72.775.5 71.8

0
10
20
30
40
50
60
70
80
90

100

Side Effects Convenience

PBO (n=73) APR (n=148) PBO/APR (n=64) APR/APR (n=121)

Week 52Week 16 Week 16

Week 52 Week 52Week 16 Week 16

38.8
48.7

57.3
63.2*

*
57.7 59.2

54.1
59.9

0
10
20
30
40
50
60
70
80
90

100

Effectiveness Global Satisfaction

*P<0.0001 vs. PBO. Error bars represent 95% CIs.

Safety
• The most common AEs reported with APR treatment from 0 to 52 weeks included diarrhea, nausea, headache, and 

nasopharyngitis; most AEs were mild or moderate in severity (Table 2).

• Exposure-adjusted incidence rates (EAIR) per 100 patient-years did not increase with longer exposure up to 52 weeks.

• No new safety or tolerability signals were observed up to 52 weeks.

RESULTS (cont’d)

Table 2. Overview of Adverse Events

Overview

Weeks 0 to 16 Weeks 0 to 52

PBO
n=73

APR
n=147

APR*
n=211

n (%) EAIR/100 pt-yrs n (%) EAIR/100 pt-yrs n (%) EAIR/100 pt-yrs
≥1 AE 35 (47.9) 262.3 92 (62.6) 459.8 142 (67.3) 242.7
≥1 Serious AE 0 (0) 0.0 3 (2.0) 7.4 10 (4.7) 6.8
≥1 Severe AE 1 (1.4) 4.9 3 (2.0) 7.5 5 (2.4) 3.4
AE leading to drug withdrawal 3 (4.1) 14.5 5 (3.4) 12.4 14 (6.6) 9.6
Most common AEs§

Diarrhea 12 (16.4) 63.7 43 (29.3) 139.8 59 (28.0) 53.8
Nausea 7 (9.6) 35.4 26 (17.7) 73.7 40 (19.0) 31.8
Headache 8 (11.0) 42.4 30 (20.4) 89.2 32 (15.2) 24.9
Nasopharyngitis 2 (2.7) 9.8 5 (3.4) 12.5 22 (10.4) 16.2
URTI 3 (4.1) 14.8 10 (6.8) 25.2 15 (7.1) 10.7
Vomiting 2 (2.7) 9.7 9 (6.1) 22.9 12 (5.7) 8.4
Decreased appetite 4 (5.5) 19.6 6 (4.1) 15.3 11 (5.2) 7.7
*Includes all patients exposed to APR, including those initially randomized to PBO and switched at Week 16 to APR.
§Reported by ≥5% of patients in any treatment group; listed in order of incidence over 52-week period.
Pt-yrs=patient-years; URTI=upper respiratory tract infection.
EAIR/100 pt-yrs=exposure-adjusted incidence rate per 100 patient-years, calculated as (number of events*100)/(total exposure time [in years] of safety population). The exposure 
time for a patient without the specifi c event is the treatment duration; the exposure time for a patient with the specifi c event is the treatment duration up to the start date 
(inclusive) of the fi rst occurrence of the specifi c event.  

CONCLUSIONS
• APR improved QOL and reduced pruritus at Week 16 in systemic- and biologic-naive patients with moderate plaque psoriasis 

(BSA 5% to 10%); these improvements were maintained over 52 weeks with continued APR treatment.

• The benefi cial effects of APR on QOL and pruritus were consistent with those previously reported in patients with moderate to 
severe plaque psoriasis in randomized phase III trials.8,11

• Global treatment satisfaction was greater with APR than with PBO at Week 16, and satisfaction remained high over 52 weeks of 
APR treatment.

• The safety and tolerability of APR were consistent with previous studies.6,7 No new safety or tolerability issues were observed with 
APR treatment up to 52 weeks.

REFERENCES
1. Menter A, et al. J Am Acad Dermatol. 2011;65:137-174.
2. Armstrong AW, et al. JAMA Dermatol. 2013;149:1180-1185.
3. Lebwohl MG, et al. J Am Acad Dermatol. 2014;70:871-881.
4. Reich A, et al. Acta Derm Venereol. 2010;90:257-263.
5. Schafer PH, et al. Cell Signal. 2014;26:2016-2029.
6. Papp K, et al. J Am Acad Dermatol. 2015;73:37-49.

7. Paul C, et al. Br J Dermatol. 2015;173:1387-1399.
8. Thaci D, et al. J Eur Acad Dermatol Venereol. 2017;31:498-506.
9. Finlay AY, et al. Clin Exp Dermatol. 1994;19:210-216.

10. Atkinson MJ, et al. Value Health. 2005;8(Suppl 1):S9-S24.
11. Sobell JM, et al. Acta Derm Venereol. 2016;96:514-520.

ACKNOWLEDGMENTS
The authors acknowledge fi nancial support for this study from Celgene Corporation. The authors received editorial support in the preparation of this report from 
Amy Shaberman, PhD, of Peloton Advantage, LLC, Parsippany, NJ, USA, funded by Celgene Corporation, Summit, NJ, USA. The authors, however, directed and are fully 
responsible for all content and editorial decisions for this poster.

CORRESPONDENCE
Jerry Bagel – Dreamacres1@aol.com

DISCLOSURES
JB: AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfi zer, and Valeant – advisory board member, speaker, consultant, 
and/or research support; Sun Pharma – consultant. ML: Mount Sinai (which receives funds from Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Janssen/Johnson 
& Johnson, Kadmon, MedImmune/AstraZeneca, Novartis, Pfi zer, and ViDac). LSG: Celgene Corporation, LEO Pharma, Novartis, Pfi zer, and Stiefel/GlaxoSmithKline – 
investigator and/or consultant. JMJ: AbbVie, Amgen, Celgene Corporation, Dermira, Eli Lilly, Galderma, Genentech, Janssen, Medimetriks, Merck, Novartis, Pfi zer, Promius, 
and TopMD – research support, honoraria, consultant, and/or other support. JG & EL: Celgene Corporation – employment.  KCD: AbbVie, Amgen, Boehringer Ingelheim, 
Bristol-Myers Squibb, Celgene Corporation, Centocor/Janssen, Eli Lilly, Novartis, Pfi zer, Regeneron, Stiefel, and XenoPort – consultant, steering committee member, advisory 
board member, has received grants, and/or has received honoraria. BS: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene Corporation, Dermira, Eli Lilly, Forward 
Pharma, Janssen, LEO Pharma, Maruho, Medac, Novartis, Pfi zer, Stiefel/GlaxoSmithKline, Sun Pharma, and UCB – honoraria as a consultant and advisory board member; 
AbbVie, Amgen, Celgene Corporation, Eli Lilly, Janssen, Merck, Novartis, and Pfi zer – payments (to the University of Connecticut) as an investigator; CORRONA Psoriasis 
Registry – fees as a scientifi c director; AbbVie and Janssen – grant support (to the University of Connecticut for Fellowship Program).

Effi cacy of Apremilast on Quality-of-Life Measures in Patients With Moderate Plaque 
Psoriasis (UNVEIL Phase IV Study)
Jerry Bagel, MD1; Mark Lebwohl, MD2; Linda Stein Gold, MD3; J. Mark Jackson, MD4; Joana Goncalves, MD5; Eugenia Levi, PharmD5; Kristin Callis Duffi n, MD6; Bruce Strober, MD7
1Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Henry Ford Health System, West Bloomfi eld, MI; 4University of Louisville, Forefront Dermatology, Louisville, KY; 5Celgene Corporation, Summit, NJ; 6University of Utah, 
Salt Lake City, UT; 7University of Connecticut, Farmington, CT, and Probity Medical Research, Waterloo, Ontario, Canada

Presented at: the 2017 Fall Clinical Dermatology Conference; October 12–15, 2017; Las Vegas, NV.


	FC17PosterCelgeneBagelEfficacyApremilastMPPUNVEIL.pdf