What to Know About the Latest Topical Therapy Approved for Psoriasis

In April 2019, the FDA approved a new topical therapy for psoriasis—Duobrii (halobetasol propionate tazarotene 0.01%/0.045% lotion).¹ This therapy will offer patients a new option for controlling plaque psoriasis, particularly ones with mild disease. According to Lawrence Green, MD, this new therapy appears to be comparably effective as any class I steroid cream with much less of the risks associated with steroid use.

“I think it is a great addition to our ability to treat mild plaque psoriasis,” Dr Green said.

Maximizing Efficacy, Improving Safety

According to Dr Green, tazarotene has been approved for psoriasis for years but is known for the potential to cause irritation among patients with plaque psoriasis. The combination of tazarotene with the topical steroid, halobetasol, reduces the potential for irritation and decreases the risk of steroid-induced atrophy, while also maximizing efficacy.

Several clinical trials demonstrated the safety and efficacy of combination topical tazarotene and halobetasol, with significant results seen as early as 2 weeks among 47.5% of participants in clinical studies.² Trials also showed the combination of both agents was more effective than either part on its own or vehicle at achieving skin clearance after 8 weeks, and were sustained during the 4-week posttreatment phase.^3,4

In clinical trials, halobetasol propionate tazarotene 0.01%/0.045% lotion showed continued efficacy and favorable safety profile, with contact dermatitis (6.3%), application site pain (2.6%), and pruritis (2.2%) being the most commonly reported adverse events.⁵ A study that assessed the potential of contact sensitization of topical halobetasol 0.01%/tazarotene 0.045% lotion found no evidence of contact sensitization and that it only caused minimal skin irritation, particularly when compared with tazarotene alone.⁶

In addition, the topical therapy was studied for a year in participants who did not achieve treatment success after 8 weeks. The researchers observed adverse events that were similar to those reported in the shorter phase 2 and 3 trials, with no new safety signals.⁷

“Even though these participants could apply daily medication for about 6 months, no signals for local or systemic adverse events were noted,” said Dr Green. “If a topical steroid alone was used for 6 months, we would expect cutaneous adverse events like atrophy.”

The long-term safety of this therapy suggests that patients who may require longer treatment durations to see results will not experience steroid-related atrophy and telangiectasia.

Areas of Future Research

Patients with mild psoriasis in general or who have only mild psoriasis remaining following systemic treatment with a biologic may benefit from this new therapy. Patients with thick, stubborn plaques may also benefit from this therapy. However, Dr Green does not recommend prescribing this or any topical product for patients with psoriasis on larger percentages of their body.

“It is not meant to replace a systemic therapy like oral agents or biologics,” he added.

In addition, he cautions the use of this agent on the face, groin, or intertriginous areas as there are no studies evaluating the safety and efficacy of this therapy in those areas at this time.

—Melissa Weiss

References

1. Ortho Dermatologics receives FDA approval of Duobrii (halobetasol proprionate and tazarotene lotion 0.01%/0.045% for plaque psoriasis in adults [press release]. Raleigh, NC: Ortho Dermatologics; April 25, 2019. Accessed April 26, 2019.

2. Stein Gold L, Kircik LH, Pariser D, Sugarman JL, Lin T, Kang R, Pillai R. Rapid Onset of Action in Patients With Moderate-to-Severe Plaque Psoriasis With Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination. J Drug Dermatol. 2018;17(8):863-868.

3. Sugarman JL, Gold LS, Lebwohl MG, Pariser DM, Alexander BJ, Pillai R. A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis. J Drugs Dermatol. 2017;16(3):197-204.

4. Pariser DM, Green LJ, Stein Gold L, Sugarman JL, Lin T, Pillai R. Halobetasol 0.01%/Tazarotene 0.045% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Maintenance of Therapeutic Effect After Cessation of Therapy. J Drug Dermatol. 2018;17(7):723-726.

5. Sugarman JL, Weiss J, Tanghetti EA, et al. Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies. J Drug Dermatol. 2018;17(8):855-861.

6. Del Rosso J, Kircik L, Lin T, Pillai R. Halobetasol 0.01%/Tazarotene 0.045% Fixed-combination Lotion in the Treatment of Plaque Psoriasis: Sensitization and Irritation Potential. J Clin Aesthet Dermatol. 2019;12(1):11-15.

7. Lebwohl MG, Sugarman JL, Stein Gold L, et al. Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2019;80(1):282-285.