Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Efficacy by Baseline Disease Characteristics 
and Demographics in Two Pivotal Phase 3 Trials

Leon Kircik,1,2 Linda Stein Gold,3 James Del Rosso,4 Seemal R. Desai,5,6 Brad P. Glick,7 Howard Sofen,8 Anna M. Tallman,9 David S. Rubenstein,9 Philip M. Brown9 
1Skin Sciences PLLC, Louisville, KY, USA; 2Icahn School of Medicine at Mount Sinai, New York, NY, USA; 3Henry Ford Health System, Detroit, MI, USA; 4JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV, USA; 5University of Texas Southwestern Medical Center, Dallas, TX, USA; 6Innovative Dermatology, Plano, TX, USA; 

7Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA; 8David Geffen UCLA School of Medicine, Los Angeles, CA, USA; 9Dermavant Sciences, Inc., Morrisville, NC, USA

 SYNOPSIS

■ Tapinarof is a first-in-class, non-steroidal, topical therapeutic aryl 
hydrocarbon receptor modulating agent (TAMA) in development for 
the treatment of psoriasis and atopic dermatitis 

■ In two identical, randomized, double-blind Phase 3 trials, PSOARING 1 
and PSOARING 2, tapinarof cream 1% once daily (QD) demonstrated 
highly statistically significant efficacy versus vehicle at 12 weeks and 
was well tolerated in adults with mild to severe plaque psoriasis1

 OBJECTIVE

■ To present results for the pivotal Phase 3 primary efficacy endpoint 
(proportion of patients who achieved a Physician Global Assessment 
[PGA] response at Week 12) by baseline disease characteristics and 
demographics using pooled data from PSOARING 1 and PSOARING 2

 METHODS

Study Design

■ Patients with mild to severe plaque psoriasis were randomly assigned 
2:1 to receive tapinarof cream 1% QD or vehicle QD for 12 weeks in 
two identical, Phase 3, multicenter (US and Canada), double-blind, 
vehicle-controlled trials (Figure 1)

■ Following the double-blind period, patients could enroll in a separate 
open-label, long-term extension study for an additional 40 weeks 
of treatment, or complete a follow-up visit 4 weeks after the end of 
treatment (Week 16)

Figure 1. Study Design

*PGA of 2 (mild) or 4 (severe) was limited to ~10% each of the total randomized population; ~80% of the 
randomized population had a PGA of 3 (moderate). 
BSA, body surface area; PGA, Physician Global Assessment; QD, once daily; R, randomized.

Endpoints and Statistical Analysis 

■ The primary endpoint was PGA response at Week 12, defined as the 
proportion of patients with a PGA score of clear (0) or almost clear (1) 
and ≥2-grade improvement in PGA score from baseline to Week 12

■ The incidence, frequency, and nature of adverse events (AEs) and 
serious AEs were monitored from the start of study treatment until  
the end-of-study visit 

■ The pooled analyses used multiple imputation for the intention-to-treat 
(ITT) populations in PSOARING 1 and 2

■ Tapinarof cream 1% QD and vehicle groups were compared within each 
subgroup for the primary endpoint using 95% confidence intervals for 
the relative risk calculated using Cochran-Mantel-Haenszel analyses 
stratified by baseline PGA score 

 RESULTS

Patient Disposition and Baseline Characteristics 

■ The pooled analysis population included 1025 patients randomized to 
tapinarof cream 1% QD (n=683) or vehicle QD (n=342) in PSOARING 
1 and 2 (ITT population) 

■ Baseline disease characteristics and demographics in the pooled 
population were comparable across treatment groups (Table 1)

■ Overall, at baseline, 82% had a PGA score of 3 (moderate), 57% had 
psoriasis for >10 years, and 26% had ≥10% body surface area  
(BSA) affected

Table 1. Baseline Patient Demographics and Disease Characteristics 
(Pooled PSOARING 1 and 2)

Tapinarof 1% QD 
(n=683)

Vehicle QD 
(n=342)

Age <65 years, n (%) 584 (85.5) 302 (88.3)

Male, n (%) 401 (58.7) 188 (55.0)

Race, n (%)

Caucasian 586 (85.8) 284 (83.0)

Asian 46 (6.7) 25 (7.3)

Black/African American 30 (4.4) 17 (5.0)

American Indian or Alaska Native 2 (0.3) 2 (0.6)

Native Hawaiian or Other Pacific Islander 1 (0.1) 1 (0.3)

Other* 13 (1.9) 10 (2.9)

Country of enrollment, n (%)

US 514 (75.3) 262 (76.6)

Canada 169 (24.7) 80 (23.4)

PGA, n (%)

2 – Mild 67 (9.8) 36 (10.5)

3 – Moderate 559 (81.8) 277 (81.0)

4 – Severe 57 (8.3) 29 (8.5)

BSA affected, n (%)

<10% 505 (73.9) 257 (75.1)

≥10% 178 (26.1) 85 (24.9)

Duration of disease, n (%)

<5 years 154 (22.5) 73 (21.3)

5-10 years 128 (18.7) 89 (26.0)

>10 years 401 (58.7) 180 (52.6)

*Includes patients with multiple races reported. ITT population. 
BSA, body surface area; ITT, intention-to-treat; PGA, Physician Global Assessment; QD, once daily. 

PGA Response by Baseline Disease Characteristics and 
Demographics

■ The primary endpoint (PGA of 0 or 1 and ≥2-grade improvement 
at Week 12) was met; PGA response rates were highly statistically 
significant in the tapinarof cream 1% QD group versus the vehicle 
group in both PSOARING 1 and 2: 35.4% vs 6.0% (P<0.0001) and 
40.2% vs 6.3% (P<0.0001), respectively1

■ The efficacy of tapinarof 1% QD was consistent across subgroups, 
regardless of baseline disease characteristics such as PGA score, 
%BSA affected, and duration of disease, and demographics such as 
sex, age, race, country of enrollment (Figure 2)

■ Notably, based upon the definition of PGA response requiring 
achievement of PGA=0 or 1 with ≥2-grade improvement, mild subjects 
had to achieve complete disease clearance (PGA=0) and severe 
subjects had to improve a minimum of 3 points, to be responders

Figure 2. PGA Response at Week 12 by Baseline Disease 
Characteristics (A) and Demographics (B) (Pooled PSOARING 1 
and 2) 

*Lower limit of the 95% CI for the relative risk >1, indicating a significantly higher probability of PGA response with 
tapinarof compared with vehicle. Relative risk and associated 95% CIs were calculated using Cochran-Mantel-Haenszel 
analyses, stratified by baseline PGA score. Relative risk indicates the probability of PGA response occurring in the 
tapinarof group versus the probability of PGA response occurring in the vehicle group. †Non-Caucasian category includes 
Asian, Black/African American, American Indian or Alaska Native, Native Hawaiian, or Other Pacific Islander, and Other 
and has been grouped due to small patient numbers.
ITT, MI. Mean proportion (SE). PGA response defined as a PGA score of clear (0) or almost clear (1) with ≥2-grade 
improvement from baseline. CI, confidence interval; ITT, intention-to-treat; MI, multiple imputation; PGA, Physician Global 
Assessment; QD, once daily; SE, standard error.  

Safety

■ Treatment-emergent AEs (TEAEs) were mostly mild to moderate  
in severity

■ The most common TEAEs overall were folliculitis (20.2% tapinarof vs 
0.9% vehicle), nasopharyngitis (5.7% tapinarof vs 4.4% vehicle), and 
contact dermatitis (4.8% tapinarof vs 0.3% vehicle)

■ Although conclusions cannot be drawn due to the small number of 
patients in some subgroups, the frequency and type of AEs appeared 
to be generally comparable across subgroups and consistent with 
those observed in the overall population

 CONCLUSIONS

■ Tapinarof cream 1% QD was consistently efficacious and well tolerated 
irrespective of baseline PGA score, BSA affected, duration of psoriasis, 
sex, age, race, or country of enrollment (US or Canada) 

■ Due to the small number of patients in some subgroups, limitations 
exist regarding the ability to draw definitive conclusions from the 
subgroup analysis

■ The consistent efficacy and tolerability in all subgroups support the 
potential use of tapinarof cream 1% QD across a broad spectrum of 
disease severity and patient demographics

■ A long-term extension trial (PSOARING 3) of intermittent treatment 
with tapinarof 1% QD based on PGA score demonstrated continued 
efficacy following the 12-week pivotal trials and an ~4-month remittive 
effect off therapy2 

■ Tapinarof cream 1% QD has potential to be the first topical psoriasis 
treatment with a novel mechanism of action in almost 20 years

 REFERENCES
1. Lebwohl M, et al. Skin. 2020;4(6):s75. https://doi.org/10.25251/skin.4.supp.75; 2. Strober B, et al. Innovations in 
Dermatology Virtual Spring Conference 2021, Poster Presentation, March 16–20, 2021. 

 ACKNOWLEDGMENTS
This study was funded by Dermavant Sciences, Inc. The authors thank the participating investigators, patients and 
their families, and colleagues involved in the conduct of the study. L.K. has served as a consultant/speaker/investigator/
advisory board member for Abbott Laboratories, Abbvie, Ablynx, Aclaris, Acambis, Allergan, Inc., Almirall, Amgen, Inc., 
Anacor Pharmaceuticals, Anaptys, Arcutis, Arena, Assos Pharma, Astellas Pharma US, Inc., Asubio, Bausch Health, 
Berlex Laboratories (Bayer HealthCare Pharmaceuticals), Biogen-Idec, Biolife, Biopelle, BMS, Boehringer-Ingleheim, 
Breckinridge Pharma, Cassiopea, Centocor, Inc., Cellceutix, Cipher, Coherus, Colbar, Combinatrix, Connetics Corporation, 
Coria, Dermavant Sciences, Inc., Dermira, Dermik Laboratories, Dow Pharmaceutical Sciences, Inc., Dr. Reddy’s Lab, 
Dusa, Embil Pharmaceuticals, Eli Lilly, EOS, Exeltis, Ferndale Laboratories, Inc., Foamix, Ferrer, Galderma, Genentech, 
Inc., GlaxoSmithKline, PLC, Glenmark, Health Point, LTD, Idera, Incyte, Intendis, Innocutis, Innovail, Isdin, Johnson & 
Johnson, Kyowakirin, Laboratory Skin Care, Inc., LEO Pharma, L’Oreal, 3M, Maruho, Medical International Technologies, 
Merck, Medicis Pharmaceutical Corp., Merz, Nano Bio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals 
Corp, Obagi, Onset, OrthoNeutrogena, PediaPharma, Pfizer, Promius, PuraCap, PharmaDerm, QLT, Inc, Quinnova, 
Quatrix, Regeneron, Sanofi, Serono (Merck Serono International SA), SkinMedica, Inc., Stiefel Laboratories, Inc., Sun 
Pharma, Taro, TolerRx, Triax, UCB, Valeant Pharmaceuticals Intl, Warner-Chilcott, XenoPort, ZAGE. L.S.G has served 
as a consultant, and/or has received payment for the development of educational presentations, and/or has received 
grants from Arcutis, Amgen, Bristol Myers Squibb, Dermavant Sciences, Inc., Eli Lilly, LEO Pharma, Ortho Dermatologic, 
and UCB Biopharma. J.D.R is an advisor and research investigator for Dermavant Sciences, Inc. B.P.G. has served as 
an investigator/speaker/advisor for AbbVie, Brickell Biotech, Celgene, ChemoCentryx, Corrona Registry PSO, Corrona 
Registry AD, Dermavant Sciences, Inc, Dermira, Eli Lilly, Janssen, Novartis, Ortho Dermatologics, Pfizer, Prose Registry, 
Regeneron, Sanofi-Genzyme, Sun Pharmaceutical Industries, Inc. H.S. has served as scientific adviser and/or clinical 
study investigator for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Sciences Inc., Eli Lilly, Incyte, 
Janssen, LEO Pharma, Novartis, Pfizer, Sanofi-Genzyme, Sun Pharma, UCB. A.M.T, D.S.R and P.M.B. are employees 
of Dermavant Sciences, Inc., with stock options. Editorial and medical writing support under the guidance of the authors 
was provided by Apothecom, UK, and was funded by Dermavant Sciences, Inc. in accordance with Good Publication 
Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461–464). Contact Dr Leon Kircik at wedoderm@yahoo.com  
with questions or comments.

Adult patients with
plaque psoriasis

• Aged 18–75 years old

• PGA score ≥2*

• BSA ≥3%–≤20%

Double-blind
treatment
(12 weeks)

2:1

2:1

Tapinarof 1% QD
(n=340)

Tapinarof 1% QD
(n=343)

Vehicle QD
(n=170)

Vehicle QD
(n=172)

(N=510)

(N=515)

R

R

P
ro

p
o

rt
io

n
 o

f 
p

at
ie

n
ts

, %

19.9%

5.8%

0%
2

(mild)
3

(moderate)
4

(severe)
<10% ≥10% <5

years
5−10
years

>10
years

Baseline PGA BSA Affected Duration of disease

40.1%
*

6.4%

36.3%
*

4.7%

38.6%
*

5.1%

35.6%
*

9.3%

34.8%
*

7.8%

36.9%
*

4.1%

39.3%
*

6.5%10%

20%

30%

40%

Tapinarof 1% QD
Vehicle QD

50%

60%(A)

P
ro

p
o

rt
io

n
 o

f 
p

at
ie

n
ts

, %

0%

10%

20%

30%

40%

50%

60%(B)

Sex

38.5%

5.3%

Male

*

Female

36.9%

7.2%

*

Age

<65
years

36.4%

5.7%

*

≥65
years

46.1%
*

9.6%

Race (binary)†

Caucasian

*
38.8%

6.4%

Non-
Caucasian

*
30.5%

5.3%

Country of
enrollment

US

*
36.1%

6.0%

Canada

*
42.9%

6.5%

Tapinarof 1% QD
Vehicle QD