Introduction
 � A foam formulation of fixed combination calcipotriol  

50 µg/g (Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) 
has been developed as a treatment option for patients  
with psoriasis1

 � The Phase III PSO-FAST (Cal/BD foam in PSOriasis vulgaris, 
a Four-week, vehicle-controlled, efficacy And Safety Trial) study 
demonstrated that Cal/BD foam provides significantly 
greater efficacy than vehicle in patients with psoriasis2

 � Itch is a common and distressing aspect of psoriasis that 
negatively impacts on a patient’s quality of life, causing discomfort, 
potentially aggravating the lesion, and often leading to sleep loss3,4

 � In this sub-analysis of the PSO-FAST study we assessed changes 
in itch during treatment with Cal/BD foam, in patients who had 
clinically relevant itch at baseline (defined as visual analogue scale 
[VAS] score of >30)5

Methods
STUDY DESIGN AND PATIENTS 

 � PSO-FAST was a Phase III, multicentre, double-blind, randomized 
study conducted at 27 sites in the United States (NCT01866163)2

 � Patients were randomized (3:1) to Cal/BD foam or foam 
vehicle once daily for up to 4 weeks

 � Patient eligibility: aged ≥18 years; at least mild psoriasis, according 
to the Physician’s Global Assessment of disease severity; modified 
Psoriasis Area and Severity Index (mPASI) score of ≥2; and, 2–30% 
body surface area (BSA; trunk and/or limbs) affected by psoriasis

ITCH ASSESSMENT
 � Itch was evaluated based on a VAS (range 0–100 mm, where 0 is 

no itch and 100 mm is the worst itch imaginable)

 � Patients assessed maximal itch intensity over the 24-hour period 
prior to days 3 and 5, and at weeks 1, 2, and 4 using a  
subject diary

STATISTICAL ANALYSIS
 � Patients included in this sub-analysis were those with a baseline itch 

VAS score >30, ie, of clinical relevance5

 � Change in VAS scores from baseline for Cal/BD and vehicle foam 
treatment groups were compared using analysis of variance 
(ANOVA), adjusting for baseline score and pooled centres

 � The proportion of patients achieving a 70% reduction in itch were 
compared between treatment groups using the Mantel-Haenszel 
method, adjusting for pooled centres

Results
PATIENTS

 � In total, 323 patients were randomized to Cal/BD foam, and 103 to 
vehicle

 – Of these, 225/323 (70%) patients in the Cal/BD foam 
treatment group, and 75/103 (73%) patients in the vehicle 
group had a baseline itch VAS score of >30 

 � Among patients with baseline itch VAS score of >30, mean (±SD) 
baseline score was 66.1 ± 19.9 in the Cal/BD foam group and 
69.9 ± 18.1 in the vehicle group

 � Treatment groups were generally well balanced in terms of 
demographic and baseline factors, although the gender balance 
was different between Cal/BD foam and vehicle (Table 1)

ASSESSMENT OF ITCH
 � Patients receiving Cal/BD foam reported significant and rapid 

reduction in itch relief compared with patients receiving vehicle

 – Itch relief was observed by day 3 and continued to improve 
during the 4-week study (Figure 1; Table 2)

 � Significant treatment differences were noted at the first 
assessment on day 3 (P=0.019) and were maintained at all 
subsequent time points throughout treatment (Figure 1; Table 2)

 � At week 4, 84.7% of patients using Cal/BD foam achieved 
a 70% reduction in their itch (Figure 2)

 – This was statistically significantly greater than vehicle (39.7%; 
OR 7.6; 95% CI 4.2, 14.0; P<0.001)

Treatment with fixed combination calcipotriol 50 µg/g and betamethasone dipropionate 0.5 mg/g 
foam provides rapid and significant itch relief in patients with psoriasis

Linda Stein Gold,1 Paul Yamauchi,2 David Pariser,3 Zhenyi Xu,4 Marie Louise Østerdal,4 Jerry Bagel5
1Henry Ford Health System, Detroit, MI, USA; 2Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 3Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, USA; 

4LEO Pharma A/S, Ballerup, Denmark; 5Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA
P1933

Poster presented at the 26th EADV Congress, Geneva, Switzerland, 13–17 September 2017

Acknowledgements
 � This study was sponsored by LEO Pharma. Medical writing support 

was provided by Andrew Jones, PhD, from Mudskipper Business 
Limited, funded by LEO Pharma

References
1. Paul C et al. Expert Opin Pharmacother 2017;18:115–21 

2. Leonardi C et al. J Drugs Dermatol 2015;14:1468–77 

3. Korman NJ et al. Dermatol Online J 2015;21 

4. Szepietowski JC & Reich A. Curr Probl Dermatol 2016;50:102–10 

5. Stander S et al. Acta Derm Venereol 2013;93:509–14 

6. Koo J et al. J Dermatolog Treat 2016;27:120–7 

7. Paul C et al. J Eur Acad Dermatol Venereol 2017;31:119–26 

8. Queille-Roussel C et al. Clin Drug Investig 2015;35:239–45 

9. Stein GL et al. J Drugs Dermatol 2016;15:951–7 

Table 1. Baseline demographic and clinical characteristics of 
patients with baseline itch score >30

Cal/BD foam 
(n=225)

Vehicle 
(n=75)

Age, years 50.6 (14.0) 45.6 (12.9)

Male:Female, n (%) 132:93 (59:41) 28:47 (37:63)

Race, n (%)

White 194 (86.2) 65 (86.7)

Duration of psoriasis, years 15.1 (13.5) 15.0 (11.1)

BSA affected, % 8.1 (7.0) 8.3 (6.8)

PGA, n (%)

Mild 29 (12.9) 11 (14.7)

Moderate 174 (77.3) 53 (70.7)

Severe 22 (9.8) 11 (14.7)

mPASI score 7.8 (5.0) 8.4 (7.3)

Data are shown as mean (standard deviation [SD]), unless otherwise stated

Table 2. Adjusted mean itch VAS scores during treatment in 
patients with baseline itch score >30

Cal/BD 
foam, 
mean 

change

Vehicle,  
mean 

change
Mean difference 

(95% CI) P value

Day 3 –31.4 –23.5 –7.86 (–14.41, –1.30) 0.019

Day 5 –41.4 –29.1 –12.25 (–18.65, –5.85) <0.001

Week 1 –46.2 –30.8 –15.42 (–21.82, –9.01) <0.001

Week 2 –51.7 –31.9 –19.82 (–26.16, –13.47) <0.001

Week 4 –56.7 –31.1 –25.60 (–31.96, –19.25) <0.001

CI, confidence interval

Figure 1. Adjusted mean change in itch VAS scores over 
4 weeks in patients with baseline itch score >30 
(observed cases) 

Bars represent 95% confidence intervals (CI);  
*P=0.019; **P<0.001 Cal/BD foam vs vehicle

Ad
ju

st
ed

 m
ea

n 
ch

an
ge

 fr
om

ba
se

lin
e 

in
  it

ch
 V

AS
 sc

or
e

Cal/BD foam Vehicle

N=225 215 213 216 217 216

N=75 72 72 75 74 73

0

-10

-20

-30

-40

-50

-60

-70
0 Day 3

*

**

**

**

**

Day 5 Week 2 Week 4Week 1

Figure 2. Proportion of patients with baseline itch score >30 
achieving a 70% reduction in itch by visit (observed cases)

Day

Pa
tie

nt
s (

%
)

Cal/BD foam Vehicle

90

80

70

60

50

40

20

0
42153

10

Week

30

34.0
(n=215)

22.2
(n=72)

50.2
(n=213)

29.2
(n=72)

60.6
(n=216)

32.0
(n=75)

72.4
(n=217)

45.0
(n=74)

39.7
(n=73)

84.7
(n=216)

P=0.002

P<0.001

P<0.001

P<0.001

 � Itch is considered one of the most distressing symptoms of 
psoriasis, but current treatment options are limited4

 � This analysis of patients with psoriasis who had clinically 
relevant itch at baseline demonstrates that Cal/BD foam 
leads to rapid and significant relief of itch, which 
continues to improve throughout treatment

 � These findings expand on the primary efficacy results of the 
PSO-FAST study, showing that Cal/BD foam is highly 
efficacious and well tolerated in patients with psoriasis2,6-9

Conclusions

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