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PRESENTED AT 40TH ANNUAL FALL CLINICAL DERMATOLOGY CONFERENCE, OCTOBER 29–NOVEMBER 1, 2020

REFERENCES
1. Griffiths CE, Barker JN. Lancet 2007;370:263-271.
2. Boehncke W-H, Schön MP. Lancet 2015;386:983-994.
3. Papp KA, et al. J Drugs Dermatol 2020;19:734-740.
4. Lebwohl MG, et al. N Engl J Med 2020;383:229-239. 
5. Lebwohl M, et al. Int J Dermatol 2014;53:714-722.
6. Strober BE, et al. Value Health 2013;16:1014-1022.
7. Strober B, et al. Int J Dermatol 2016;55:e147-e155.
8. Finlay AY, Khan GK. Clin Exp Dermatol 1994;19:210-216.

Leon H. Kircik,1 Mark G. Lebwohl,2 Kim A. Papp,3 Melinda J. Gooderham,4 Linda Stein Gold,5 Zoe D. Draelos,6 Steven E. Kempers,7 Stephen K. Tyring,8 Lorne E. Albrecht,9 Marni Wiseman,10 Laura K. Ferris,11 Kathleen Smith,12
Robert C. Higham,12 Lynn Navale,12 Howard Welgus,12 David R. Berk12
1Icahn School of Medicine at Mount Sinai, New York, NY, Indiana Medical Center, Indianapolis, IN, Physicians Skin Care, PLLC, Louisville, KY, and Skin Sciences, PLLC, Louisville, KY, USA; 2Icahn School of Medicine at Mount Sinai, New York, NY, USA; 3Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada;                                                 
4SkiN Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada; 5Henry Ford Medical Center, Detroit, MI, USA; 6Dermatology Consulting Services, High Point, NC, USA; 7Minnesota Clinical Study Center, Fridley, MN, USA; 8McGovern Medical School, University of Texas Health Science Center, Houston, TX, USA;                                                        
9Probity Medical Research and Enverus Medical Research, Surrey, BC, Canada; 10Probity Medical Research and Skinwise Dermatology, Winnipeg, MB, Canada; 11University of Pittsburgh, Department of Dermatology, Pittsburgh, PA, USA; 12Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA

Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Burden of Signs and Symptoms in 
Adults With Chronic Plaque Psoriasis in a Phase 2b Study

INTRODUCTION
• Typical signs of plaque psoriasis include erythematous, scaly, 

well-demarcated plaques frequently associated with pain, itching, or 
burning that can have a negative effect on quality of life (QoL)1,2

• Roflumilast cream (ARQ-151), a potent phosphodiesterase-4 (PDE-4) 
inhibitor, is under investigation as a once-daily topical treatment for 
patients with chronic plaque psoriasis3,4

• In a randomized, double-blind, phase 2b trial of 331 adults with 
chronic plaque psoriasis, roflumilast cream administered once daily 
was superior to vehicle cream and led to achievement of clear or 
almost clear skin based on Investigator Global Assessment (IGA) at 
Week 6 (Figure 1)4

• The effect of roflumilast cream on various patient-reported outcome 
(PRO) measures, including psoriasis sign and symptom burden and 
QoL, was assessed as a secondary outcome in the phase 2b trial4

OBJECTIVE
• To assess the effect of roflumilast cream on patient-reported burden 

of signs and symptoms of psoriasis and on QoL

METHODS
Study Design
• Design: parallel-group, randomized, double-blind, vehicle-controlled 

phase 2b study (ClinicalTrials.gov NCT03638258)4

• Location: 30 sites in the United States and Canada
• Participants: adult patients (≥18 years) with chronic plaque psoriasis
• Eligibility: 

– Disease of at least mild severity (score ≥2 on a 5-point IGA, 
assessing plaque thickening, scaling, and erythema; a score of 0 
indicates “clear”, 1 “almost clear”, and 4 severe)

– Score of ≥2 on the modified Psoriasis Area and Severity Index 
(range: 0, no disease; 72, maximal disease)

• Intervention: roflumilast cream 0.3%, 0.15%, or vehicle; once daily 
for 12 weeks

• Primary endpoint: IGA status of “clear” or “almost clear” (score 0 or 
1) at Week 6 in the intent-to-treat population

Assessments of Sign and Symptom Burden and QoL
• Psoriasis Symptom Diary (PSD)5-7

– Total score: severity and impact of psoriasis-related signs and 
symptoms over the past 24 hours

– Burden of individual signs and symptoms: stinging (PSD Item 4), 
burning (PSD Item 6), skin cracking (PSD Item 8), pain (PSD Item 
10), and scaling (PSD Item 12)

– Each variable scored on a scale from 0 to 10, with higher scores 
indicating greater burden

• Dermatology Life Quality Index (DLQI)8
– 10 questions concerning symptoms and feelings, daily activities, 

leisure, work and study, personal relationships, and treatment in 
the last week

– Scored on a scale from 0 (no impairment of life quality) to 30 
(maximum impairment)

– Added mid-study via protocol amendment and completed by a 
subset of patients

RESULTS
• For the primary endpoint, superior efficacy was demonstrated for both dose levels of 

roflumilast cream vs vehicle cream (Figure 1)4

CONCLUSIONS
• Roflumilast once-daily cream 0.3% and 0.15% showed significant improvement of plaque 

psoriasis severity measured by achievement of IGA “clear” or “almost clear”
• Roflumilast cream demonstrated improvement in patient-reported burden of psoriasis 

signs and symptoms and QoL 
• The improvements in sign and symptom burden and QoL occurred soon after initiating 

treatment with both roflumilast cream doses and were maintained through Week 12
• Roflumilast cream was well-tolerated and application site pain was uncommon and 

similar to vehicle

• Assessments of symptom and sign burden and QoL were comparable across treatment groups 
at baseline (Table 1)

• Rapid and statistically significant improvements on the total PSD score were observed at 
Weeks 4 through 12 for the 0.3% dose (P≤0.002 vs vehicle) and as early as Week 2 for the 
0.15% dose (P≤0.014) of roflumilast (Figure 2)

• Statistically significant improvements relative to vehicle were seen in burden of individual 
patient-reported signs and symptoms of scaling by Week 2; stinging, skin cracking, and pain by 
Week 4; and burning by Week 6 for both roflumilast doses (Figure 3)

• Mean change in DLQI score from baseline at Week 12 was significantly greater for both 
roflumilast doses vs vehicle (P≤0.036) (Figure 4)

• Treatment-emergent adverse events (AEs) were uncommon in this study and were similar 
across treatment groups (Table 2)4

Figure 1. Patients Achieving IGA of “Clear” or “Almost Clear” at Week 6 (Primary 
Endpoint)

28.0%
22.8%

8.3%
Week 6

Pa
ti

en
ts

, %
 (9

5%
 C

I)

P<0.001
P=0.00440

30

20

10

0

Data are presented for intent-to-treat population. CI: confidence interval; IGA: Investigator Global Assessment.

Table 1. Baseline Assessments of PRO Measures

Mean score (SD)
Roflumilast 0.3%

(n=109)
Roflumilast 0.15%

(n=113)
Vehicle
(n=109)

PSD, total score 68.9 (41.2) 69.6 (46.2) 75.1 (42.6)
PSD Item 4: stinging 3.9 (3.2) 3.8 (3.3) 4.3 (3.3)
PSD Item 6: burning 3.5 (3.3) 3.5 (3.4) 4.0 (3.2)
PSD Item 8: skin cracking 4.0 (3.3) 4.4 (3.6) 4.7 (3.3)
PSD Item 10: pain 3.3 (3.3) 3.2 (3.4) 3.8 (3.2)
PSD Item 12: scaling 4.9 (3.0) 5.0 (3.4) 5.6 (3.4)

DLQI, total scorea 6.7 (5.5) 8.8 (7.2) 8.5 (5.6)
Data are presented for intent-to-treat population. aAssessed for 58 patients in roflumilast 0.3%, 60 in roflumilast 0.15%, and 62 in vehicle 
treatment group. DLQI: Dermatology Life Quality Index; PRO: patient-reported outcome; PSD: Psoriasis Symptom Diary; SD: standard deviation.

Figure 2. Total PSD Score Over the Course of the Study

Data are presented for intent-to-treat population. Missing data imputed using linear interpolation and last observation carried forward where 
linear interpolation was not computationally possible. LS: least squares; PSD: Psoriasis Symptom Diary.

-50
-45
-40
-35
-30
-25
-20
-15
-10

-5
0

Week 2 Week 4 Week 6 Week 8 Week 12

LS
 M

ea
n 

Ch
an

ge
 F

ro
m

 
Ba

se
lin

e 
in

 T
ot

al
 P

SD
 S

co
re

Total PSD Score

I
M
P
R
O
V
E
M
E
N
T

*

* *
* *

* * * *

Roflumilast 0.15% (n=113) Vehicle (n=109)Roflumilast 0.3% (n=109)

*Nominal P<0.05 vs vehicle

Figure 3. Patient-Reported Burden of Individual Psoriasis Signs and Symptoms

Data are presented for intent-to-treat population. Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible. LS: least squares; PSD: Psoriasis Symptom Diary.

-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0
2 4 6 8 12 2 4 6 8 12 2 4 6 8 12 2 4 6 8 12 2 4 6 8 12

LS
 M

ea
n 

Ch
an

ge
 F

ro
m

   
   

   
  

Ba
se

lin
e 

in
 P

SD
 S

co
re

* * *
*

Week
Stinging (PSD Item 4) Skin Cracking (PSD Item 8) Pain (PSD Item 10) Scaling (PSD Item 12)Burning (PSD Item 6)

*

* *
* * *

*
***

*
*

*

*
*

*
*

*
*

*
*

*
**

****
*

**

** **
**

**
*

*

Week WeekWeekWeek

Roflumilast 0.15% (n=113) Vehicle (n=109)Roflumilast 0.3% (n=109)

*Nominal P<0.05 vs vehicle

I
M
P
R
O
V
E
M
E
N
T

Figure 4. Change From Baseline in DLQI Scores

Data are presented for intent-to-treat population. Missing data imputed using linear interpolation and last observation carried forward where 
linear interpolation was not computationally possible. DLQI: Dermatology Life Quality Index; LS: least squares.

Roflumilast 0.15% (n=60) Vehicle (n=62)Roflumilast 0.3% (n=58)

DLQI Score

-5.0

-4.0

-3.0

-2.0

-1.0

0.0
Week 2 Week 4 Week 6 Week 8 Week 12

LS
 M

ea
n 

Ch
an

ge
 

Fr
om

 B
as

el
in

e 
in

 
D

LQ
I S

co
re

*
*

**

*Nominal P<0.05 vs vehicle

I
M
P
R
O
V
E
M
E
N
T

Table 2. Summary of AEs

TEAE, n (%)
Roflumilast 0.3%

(n=109)
Roflumilast 0.15%

(n=110)
Vehicle
(n=107)

Patients with any TEAE 42 (38.5) 30 (27.3) 32 (29.9)

Patients with any treatment-related TEAE 7 (6.4) 3 (2.7) 7 (6.5)

Patients with any SAEa 1 (0.9) 1 (0.9) 2 (1.9)

Patients who discontinued study due to AEb 1 (0.9) 0 2 (1.9)

Most common TEAE (>2% of patients in any group)

Upper respiratory tract infection (including viral) 9 (8.3) 8 (7.3) 4 (3.7)

Nasopharyngitis 4 (3.7) 3 (2.7) 4 (3.7)

Application site pain 2 (1.8) 1 (0.9) 3 (2.8)

Sinusitis 3 (2.8) 0 0

Urinary tract infection 0 3 (2.7) 1 (0.9)
aRoflumilast 0.3%: worsening of chest pain in a patient with history of myocardial infarction; roflumilast 0.15%: melanoma (not in treatment
area); vehicle group: acute infarction of left basal ganglia, spontaneous miscarriage. bRoflumilast 0.3%: onset of worsening psoriasis; vehicle: 
mood swings, contact dermatitis. Data are presented for safety population. AE: adverse event;  SAE: serious adverse event; TEAE: treatment-
emergent adverse event.

Roflumilast cream, an investigational once-daily topical PDE-4 inhibitor, 
may be an effective, safe, and well-tolerated nonsteroidal topical treatment for 

chronic plaque psoriasis with early onset of action 

ACKNOWLEDGEMENTS
• This study was supported by Arcutis Biotherapeutics, Inc.
• Thank you to the investigators and their staff for their participation in the trial
• We are grateful to the study participants and their families for their time and commitment
• Writing support was provided by Aleksandra Adomas, PhD, CMPP, Touch Scientific, Philadelphia, PA, 

and funded by Arcutis Biotherapeutics, Inc.

DISCLOSURES
LHK, MGL, KAP, MJG, LSG, ZDD, SEK, SKT, LEA, MW, and LKF: Investigator, consultant, and/or advisory board 
member for Arcutis Biotherapeutics, Inc. ZDD has received grant support from Arcutis Biotherapeutics, Inc. KS, 
RCH, LN, and DRB: Employees of Arcutis Biotherapeutics, Inc. HW has a patent application relevant to this work.

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• More patients discontinued the study due to an AE in the vehicle group vs the roflumilast groups
• Rates of application site pain were low and similar to vehicle
• 97% of AEs were rated mild or moderate

Roflumilast 0.15% 
(n=113)

Vehicle (n=109)

Roflumilast 0.3% (n=109)


	Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Burden of Signs and Symptoms in Adults With Chronic Plaque Psoriasis in a Phase 2b Study
















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