ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics | Presented at the Fall Clinical Dermatology Conference • October 17-20, 2019 • Las Vegas, NV

SYNOPSIS

 ◾ Psoriasis is a chronic, immune-mediated disease that can have frequent exacerbations and remissions1,2

 ◾ The use of topical therapy is a key component in the management of almost all psoriasis patients3

 ◾ Topicals are considered first-line therapy for mild disease3 and are having an increasing role in moderate-to-severe 
psoriasis as an integral part of combination therapy

OBJECTIVE

 ◾ To investigate the efficacy, safety, and tolerability of a once-daily application of a fixed combination halobetasol 
propionate 0.01% and tazarotene 0.045% (HP/TAZ; Duobrii™ Ortho Dermatologics, Bridgewater, NJ) lotion compared 
with its vehicle in patients with severe localized plaque psoriasis 

METHODS

 ◾ In two phase 3, multicenter, double-blind, vehicle-controlled studies (NCT02462070 and NCT02462122), patients were 
randomized (2:1) to receive HP/TAZ or vehicle once-daily for 8 weeks, with a 4-week posttreatment follow-up4 

• In these studies, CeraVe® hydrating cleanser and CeraVe® moisturizing lotion (L’Oreal, NY) were provided as needed for 
optimal moisturization/cleaning of the skin

 ◾ Data from these studies were pooled and analyzed post hoc in participants with severe psoriasis (Investigator Global 
Assessment [IGA] of 4 and Body Surface Area [BSA] of 3%–12%) 

 ◾ Efficacy assessments included treatment success (≥2-grade improvement from baseline in IGA score and a score of ‘clear’ 
or ‘almost clear’ [primary endpoint]), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at 
the target lesion, mean change in BSA and IGAxBSA, and the proportion of patients achieving a clinically meaningful 
response (≥50% improvement in IGAxBSA)

 ◾ Safety and treatment-emergent adverse events (TEAEs) were evaluated throughout the study

RESULTS

 ◾ A total of 62 participants with severe psoriasis (IGA 4; mean BSA 7.4%) were included in this analysis

 ◾ By Week 8, 34.8% of participants achieved treatment success with HP/TAZ compared with 0% on vehicle (P=0.004; Figure 1)

 ◾ HP/TAZ lotion was also significantly superior in reducing psoriasis signs and symptoms and reducing BSA

• At Week 8, significantly more HP/TAZ-treated participants achieved ≥2-grade improvement in erythema (47.4%), plaque 
elevation (66.4%), and scaling (65.4%) compared with vehicle (14.0% [P=0.016], 14.8% [P<0.001], and 14.7% [P<0.001], 
respectively) 

• Participants treated with HP/TAZ lotion achieved a 32.8% mean reduction from baseline in BSA, compared with a 39.6% 
increase with vehicle (P=0.013)

 ◾ HP/TAZ lotion demonstrated significantly greater reduction in IGAxBSA compared to vehicle from Week 2 onward 
(P<0.001; Figure 2)

• By Week 8, the mean reduction in IGAxBSA in HP/TAZ-treated participants was 52.9% compared with a mean increase 
of 17.5% in vehicle-treated participants (P<0.001)

• Most participants treated with HP/TAZ lotion achieved a clinically meaningful response (IGAxBSA-50) 

Efficacy, Safety, and Tolerability of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination in the  
Treatment of Severe Plaque Psoriasis: Post Hoc Analysis of Two Phase 3 Randomized Controlled Trials

Mark G Lebwohl, MD1; Jeffrey L Sugarman, MD, PhD2; Linda Stein Gold, MD3; Tina Lin, PharmD4; Gina Martin, MOT5
1Icahn School of Medicine at Mount Sinai, New York, NY; 2University of California, San Francisco, CA; 3Henry Ford Hospital, Detroit, MI; 4Ortho Dermatologics, Bridgewater, NJ; 5Bausch Health Americas, Inc, Petaluma, CA

FIGURE 1:  Percentage of Participants With Severe Psoriasis Achieving Treatment Successa by Study Visit (ITT Population; Pooled Data)

0%

30%

20%

10%

40%

50%

60%

Study Visit (Weeks)

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

Baseline 2 4 6 8 12

Treatment Posttreatment

HP/TAZ (n=39)
Vehicle (n=23)

 *P<0.05 vs vehicle; **P<0.01 vs vehicle. 
a Treatment success was defined as ≥2-grade improvement from baseline in IGA score and a score of ‘clear’ or ‘almost clear’. 
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent-to-treat.

FIGURE 2:  Mean Percent Change in IGAxBSA by Study Visit in Participants With Severe Psoriasis (ITT Population; Pooled Data)

-60%

-20%

-40%

-50%

0%

10%

20%

Study Visit (Weeks)

P
e
rc

e
n
t 

C
h
a
n
g

e
 F

ro
m

 B
a
se

lin
e

Baseline 2 4 6 8 12

Treatment Posttreatment
HP/TAZ (n=39)
Vehicle (n=23)

-30%

-10%

**P<0.01 vs vehicle; ***P<0.001 vs vehicle. 
BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent-to-treat.

 ◾ One participant (2.6%) treated with HP/TAZ lotion discontinued due to AEs

 ◾ The most frequently reported treatment-related TEAEs with HP/TAZ were application site pain (7.9%), contact dermatitis 
(5.3%) and pruritus (5.3%; Table 1)

TABLE 1:  Summary of Treatment-Emergent Adverse Events in Participants with Severe Psoriasis 
Through Week 8 (Safety Population; Pooled Data)

n (%) HP/TAZ Lotion (n=38) Vehicle Lotion (n=23)

 Participants reporting any TEAEs 18 (47.4) 8 (34.8)
 Participants reporting any SAEs 0 0 
 Deaths 0 0
 Participants discontinuing due to TEAEs 1 (2.6) 1 (4.3)
Severity of TEAEs
 Mild 8 (21.1) 2 (8.7)
 Moderate 9 (23.7) 5 (21.7)
 Severe 1 (2.6) 1 (4.3)
Relationship to study drug
 Related 8 (21.1) 3 (13.0)
 Unrelated 10 (26.3) 5 (21.7)
Treatment-related TEAEs reported in ≥2% of participants
 Application site pain 3 (7.9) 0
 Pruritis 2 (5.3) 1 (4.3)
 Contact dermatitis 2 (5.3) 0
 Rash 1 (2.6) 0
 Skin atrophy 1 (2.6) 0
 Skin lesion 1 (2.6) 0
 Telangiectasia 1 (2.6) 0
 Wound secretion 1 (2.6) 0
 Skin irritation 0 1 (4.3)
 Peripheral swelling 0 1 (4.3)
 Pain in extremity 0 1 (4.3)
 Burning sensation 0 1 (4.3)
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; SAE, serious adverse event; TEAE, treatment-emergent adverse event.

CONCLUSION
 ◾ In patients with severe localized plaque psoriasis, HP/TAZ lotion provides rapid and sustained efficacy 
with good tolerability and safety over 8 weeks of once-daily use

REFERENCES
1. Nestle FO, et al. N Engl J Med. 2009;361(5):496-509.
2. Cohen SN, et al. Clin Exp Dermatol. 2012;37 Suppl 1:13-18.

3. Menter A, et al. J Am Acad Dermatol. 2009;60(4):643-659.
4. Sugarman JL, et al. J Drugs Dermatol. 2018;17(8):855-861.

AUTHOR DISCLOSURES
M Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie, Amgen, Arcutis, AstraZeneca, Boehringer Ingelheim, Celgene, Clinuvel, Eli Lilly, Incyte, Janssen Research & Development, LLC, 
Kadmon Corp., LLC, Leo Pharmaceuticals, Medimmune, Novartis, Ortho Dermatologics, Pfizer, Sciderm, UCB, Inc., and ViDac.; is a consultant for Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., 
Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika 
Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Theravance, and Verrica. J Sugarman is a consultant for Ortho Dermatologics, Bausch Health, Regeneron, Sanofi, and Pfizer. L Stein Gold 
is an investigator/consultant or speaker for Ortho Dermatologics, LEO, Dermavant, Incyte, Novartis, AbbVie, and Lilly. T Lin is an employee of Ortho Dermatologics. G Martin is an employee of Bausch Health Americas Inc.