ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics; Ortho Dermatologics is a division of Bausch Health US, LLC | 2020 Fall Clinical Dermatology Conference® for PAs & NPs • April 3-5, 2020 • Orlando, FL

SYNOPSIS

 ◾ Psoriasis is a chronic, immune‑mediated disease that can have exacerbations and 
remissions1

 ◾ Topical therapy is the mainstay of treatment for patients with localized psoriasis2; 
however, long‑term continuous use of topical corticosteroids is not recommended due 
to the potential for local adverse events1

 ◾ Though applying topicals to large areas in more severe disease may not be practical for 
patients with very high affected body surface area (BSA), there is limited data on the 
efficacy of topical treatments in more localized severe plaque psoriasis 

 ◾ Data from phase 3 clinical trials have shown the ef ficacy and tolerability of a fixed 
combination lotion containing halobetasol propionate 0.01% and tazarotene 0.045% 
(HP/TAZ; Duobrii® Ortho Dermatologics, Bridgewater, NJ) over 8 weeks in participants 
with localized moderate‑to‑severe plaque psoriasis3,4

OBJECTIVE

 ◾ To investigate long‑term maintenance of treatment effect following cessation of 
once‑daily HP/TAZ lotion in a subgroup of participants with higher levels of affected  
BSA (6 –12%)

METHODS

 ◾ This was a 1‑year multicenter, open‑label study (NCT02462083) in participants aged 
≥18 years with moderate‑to‑severe plaque psoriasis

• Investigator’s Global Assessment (IGA) score of 3 or 4 and an affected BSA of 3 –12% 
were required for study enrollment

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

 ◾ Participants were treated with HP/TAZ lotion once‑daily for 8 weeks and intermittently in 
4‑week intervals for a maximum continuous exposure of 24 weeks (Figure 1)

• At week 8, participants who achieved treatment success stopped treatment; those who 
did not achieve treatment success were treated for 4 additional weeks

• All participants were re‑evaluated at week 12; those demonstrating ≥1‑grade 
improvement in baseline IGA continued the study and were subsequently managed in 
4‑week cycles

• If they had not achieved treatment success, they were treated once daily with  
HP/TAZ lotion 

• If they had achieved treatment success, they received no treatment until the next 
evaluation 

 ◾ A post hoc analysis was conducted to investigate maintenance of effect with HP/TAZ 
lotion in a subgroup of participants with higher baseline BSA (6 –12%); results from the 
overall study population (BSA 3 –12%) were included for comparison

Long-Term Management of Moderate-to-Severe Plaque Psoriasis: Maintenance of Treatment Success Following 
Cessation of Fixed Combination Halobetasol Propionate 0.01% and Tazarotene 0.045% (HP/TAZ) Lotion in 
Patients with Baseline Body Surface Area of 6 -12%

FIGURE 1. Open-Label Study Design

Screening

Successa

Treatment
stopped
for 4 weeks

No success
Continued
once-daily
HP/TAZ
for 4 weeks

Improvementb

Continued study and managed in 4-week cycles for up to 1 year,
with patients re-evaluated every 4 weeks for treatment successa

No improvement
Discontinued
from study

Once-
daily
HP/TAZ

1 YearWeek 24
If continuous treatment was received,
IGA score of 0 or 1 needed to continue study 
 

Day 0 Week 12 
Evaluated for ≥1-grade
improvement from
baseline IGA

Week 8
Evaluated for
treatment
successa

Maximum continuous exposure was 24 weeks. 
aTreatment success defined as score of 0 or 1 on IGA (clear or almost clear).
bImprovement defined as ≥1-grade improvement from baseline IGA. 
HP/TAZ, halobetasol propionate 0.01%/tazarotene 0.045%; IGA, Investigator’s Global Assessment.

RESULTS

 ◾ A total of 555 participants were included in the study, of which 210 (37.8%) had baseline 
BSA levels of 6 –12% (Figure 2)

FIGURE 2. Baseline BSA in Participants Treated with HP/TAZ (N=555)

4% (n=103)

5% (n=97)

6% (n=51)

7% (n=30)

8% (n=36)

10% (n=45)

12% (n=23)
11% (n=12)

9% (n=13)

3% (n=145)
3–5%
BSA

6–12%
BSA

BSA, body surface area; HP/TAZ, halobetasol propionate 0.01%/tazarotene 0.045%.

 ◾ At week 8, BSA ≤5% was achieved by 79% of the overall study population 
(baseline BSA 3 –12%) and 50% of participants with baseline BSA 6 –12% 

 ◾ This reduction in BSA was maintained in those who participated in the study for at least 
1 year (Figure 3) 

Linda Stein Gold1; Jonathan S Weiss2; Lawrence Green3; Leon Kircik4,5,6; Lauren Miller7; Abby Jacobson8; Susan Harris9
1Henry Ford Hospital, Detroit, MI; 2Georgia Dermatology Partners, and Gwinnett Clinical Research Center, Inc., Snellville, GA; 3 George Washington University School of Medicine, Washington, DC; 4Indiana University School of Medicine, Indianapolis, IN; 5Physicians Skin Care, PLLC, Louisville, KY
6Icahn School of Medicine at Mount Sinai, New York, NY; 7Dermatology Specialists of Alabama, Gadsden, AL; 8Ortho Dermatologics*, Bridgewater, NJ; 9Bausch Health US, LLC*, Bridgewater, NJ 
*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

FIGURE 3. Maintenance of ≤5% or ≤3% Affected BSA From Week 8 to End of 
Study (Safety Population)

68.7%

74.6%

36.2%

44.2%

0%

20%

40%

60%

80%

100%

43.1%

50.0%

17.7%
21.4%

0%

20%

40%

60%

80%

100%

P
e
rc

e
n
ta

g
e
 o

f 
P
ar

ti
ci

p
an

ts

Overall Study Population: Baseline BSA 3–12%a  Post Hoc Analysis: Baseline BSA 6–12%a

Subjects Participating
for ≥6 Months (n=390)

Subjects Participating
for ≥1 Year (n=42)

Subjects Participating
for ≥6 Months (n=130)

Subjects Participating
for ≥1 Year (n=138)

≤5% BSA
≤3% BSA

aOnly BSA records considered as occurring on treatment were used in assessing if the percent BSA was maintained. 
BSA, body surface area; HP/TAZ, halobetasol propionate 0.01%/tazarotene 0.045%.

 ◾ Of the participants who achieved treatment success during the study (IGA score of clear 
or almost clear), approximately one‑third had BSA ≤1% at treatment success, regardless 
of BSA severity at baseline (Figure 4) 

FIGURE 4. Body Surface Area at Treatment Successa (Safety Population)

0%

20%

40%

60%

80%

100%

P
e
rc

e
n
ta

g
e
 o

f 
P
ar

ti
ci

p
an

ts

91.2%

75.2%

55.7%

35.5%

≤5% ≤3% ≤2% ≤1%

74.5%

59.8%

46.1%

33.3%

≤5% ≤3% ≤2% ≤1%

Body Surface Area Body Surface Area

Overall Study Population: Baseline BSA 3–12%b (n=318) Post Hoc Analysis: Baseline BSA 6–12%b (n=102)

0%

20%

40%

60%

80%

100%

aTreatment success defined as score of 0 or 1 on IGA (clear or almost clear).
b BSA assessments at the Treatment Success visit were included. All BSA assessments included regardless of whether they were 
on treatment or not.

BSA, body surface area; HP/TAZ, halobetasol propionate 0.01%/tazarotene 0.045%; IGA, Investigator’s Global Assessment.

 ◾ In those participants who stopped HP/TAZ therapy after achieving treatment success, 
maintenance of therapeutic benefit is demonstrated by the extended time to 
retreatment (Table 1)

TABLE 1. Time to Retreatment With HP/TAZ Lotion (Safety Population)

Percentage of participants

Overall Study 
Population:

Baseline BSA 3 –12% 
(n=226a) 

Post Hoc 
Analysis:

Baseline BSA 6 –12%  
(n=70a)

No retreatment (did not relapse) 6.6% 5.7%

No retreatment for ≥85 days 19.5% 12.9%

No retreatment for ≥57 days 28.3% 21.4%

No retreatment for ≥29 days 55.3% 44.3%

a Participants still enrolled post 8 weeks in the study and who stopped therapy after achieving treatment success 
(defined as a score of 0 or 1 on IGA).

BSA, body surface area; HP/TAZ, halobetasol propionate 0.01%/tazarotene 0.045%; IGA, Investigator’s Global Assessment.

CONLUSIONS
 ◾ In participants with moderate‑to‑severe psoriasis and a baseline BSA 
of 6 –12%, HP 0.01%/TAZ 0.045% lotion provided rapid and 
sustained treatment success, with nearly 45% of participants 
followed for 1 year not requiring retreatment for ≥1 month

REFERENCES

1. Weigle N, et al. Am Fam Physician. 2013;87(9):626-633.

2. Torsekar R, et al. Indian Dermatol Online J. 2017;8(4):235-245.

3. Stein Gold L, et al. J Am Acad Dermatol. 2018;79(2):287-293.

4. Sugarman JL, et al. J Drugs Dermatol. 2018;17(8):855-861.

AUTHOR DISCLOSURES

Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO, Dermavant, 
Incyte, Novartis, AbbVie, and Lilly. Jonathan S Weiss is a consultant, speaker, advisor, and/or researcher for 
Abbvie, Ortho Dermatologics, Jansen Biotech, Dermira, Almirall, Brickell Biotech, DermTech, Scynexis. 
Lawrence Green has served as consultant, speaker, and/or investigator for Arcutis, Abbvie, Amgen, Celgene, 
Dermavant, Jannsen, Lilly, MC2, Novartis, OrthoDerm, Sienna, SunPharma, UCB. Leon Kircik has acted as an 
investigator, advisor, speaker, and consultant for Ortho Dermatologics. Lauren Miller is speaker for Lilly, 
Novartis, Amgen, and Pfizer. Abby Jacobson is an employee of Ortho Dermatologics and may hold stock and/or 
stock options in its parent company. Susan Harris is an employee of Bausch Health US, LLC and may hold stock 
and/or stock options in its parent company.