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New Treatments for Plaque Psoriasis
Psoriasis continues to be a significant cause of morbidity in the United States. According to the most recent estimates, psoriasis affects roughly 0.91% to 8.5% of the global population, with estimates ranging from 2.2% to 3.15% for individuals in the United States.1 Approximately 17% of patients have moderate to severe psoriasis, requiring systemic treatment, typically biologics.2
The mainstay treatments for plaque psoriasis include topical therapies, phototherapy, systemics, anti-tumor necrosis factor inhibitors, and anti-IL-12/IL-23, anti-IL-17, and anti-IL-23 agents. Despite the development of these agents, a significant portion of patients still do not obtain adequate control of their psoriasis or they develop eventual resistance to therapy via induction of neutralizing antidrug antibodies.3
Adequate control of psoriasis is essential not only due to the primary disease, but also comorbidities including psoriatic arthritis and mental health conditions, which have a significant impact on the short- and long-term health of patients. Two new drugs, likely to be approved by the FDA soon, may offer dermatologists new therapeutic options to control and maintain plaque psoriasis—topical halobetasol/tazarotene (Duobrii) lotion and risankizumab.
Topical Halobetasol/Tazarotene Lotion
Topical combination of halobetasol and tazarotene resulted in encouraging results for the treatment of plaque psoriasis. Early studies showed that topical corticosteroids have a synergistic effect when paired with tazarotene in efficacy and safety compared with each agent alone.
The results of 2 randomized phase 3 trials supported the efficacy of halobetasol/tazarotene lotion among a total of 418 participants (registered on ClinicalTrials.gov as NCT02462070 and NCT02462122).4 Significant primary outcome successes were met compared with the vehicle, defined as a 2-grade improvement from the baseline on Investigator’s Global Assessment score and a score of almost clear or clear.4 At week 8, 35.8% of participants in study 1 and 45.3% of participants in study 2 achieved the primary outcome compared with 7.0% and 12.5% of those in the control group in study 1 and 2, respectively. Participants treated with halobetasol/tazarotene also maintained treatment success over the 4-week posttreatment period compared with vehicle (33.3% and 33.4% vs 8.5% and 8.8% in study in 1 and 2, respectively).4
In addition, the studies also showed good tolerance and safety of topical halobetasol/tazarotene lotion. The most common adverse effects were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).4,5 Only 7.5% of participants discontinued the medication due to adverse effects. In addition, serious adverse effects during treatment were noted to not be treatment-related and no association was seen with other cutaneous adverse effects including skin atrophy, folliculitis, telangiectasia, and striae.5
The manufacturer of halobetasol/tazarotene lotion, Ortho Dermatologics, submitted the drug for FDA approval in 2018. It was not approved at that time due to questions regarding the pharmacokinetics of the product. However, there were no issues regarding its efficacy or safety. After addressing the concerns of the FDA, the manufacturer resubmitted halobetasol/tazarotene for approval. If approved, halobetasol/tazarotene may be a promising topical treatment for those living with plaque psoriasis.
Risankizumab
Risankizumab is another therapy for the treatment of plaque psoriasis that has the potential to change the treatment landscape for this immune-mediated disease. The biologic is a monoclonal inhibitor of IL-23, a cytokine that has been found to stimulate the survival and proliferation of TH17 cells involved in cytokine secretion that drives keratinocyte hyperproliferation.6 Two phase 3 trials, UltIMMa-1 and UltIMMa-2, compared the efficacy and safety of risankizumab with ustekinumab (Stelara).7
At week 16, the UltIMMa-1 study showed 75.3% of participants treated with risankizumab achieved Psoriasis Area and Severity Index of 90 compared with 47.5% of those treated with ustekinumab. In UltIMMa-2, 83.7% of participants on risankizumab achieved a static Physician’s Global Assessment of 0 or 1 at week 16 compared with 61.6% on ustekinumab. In both studies, risankizumab showed superior efficacy when compared with ustekinumab.7
Risankizumab had a safety profile similar to ustekinumab. In UltIMMa-1 and UltIMMa-2, risankizumab had an adverse event rate of 49.7% and 45.6% vs 50% and 53.5% for ustekinumab, respectively.7 Based on these results, risankizumab has the potential to be the preferred biologic for moderate to severe plaque psoriasis based on efficacy and maintenance dosing of every 12 weeks.
Mr Zang is with the Keck School of Medicine at the University of Southern California in Los Angeles, CA.
Mr Kearns is with the Loma Linda School University School of Medicine in Loma Linda, CA.
Ms Chat is with the Medical College of Georgia at Augusta University in August, GA.
Dr Wu is with the Dermatology Research and Education Foundation in Irvine, CA.
Disclosures: Dr Wu is an investigator for AbbVie, Amgen, Eli Lilly, Janssen, Novartis; a consultant for AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Promius Pharma, Regeneron, Sun Pharmaceutical, and UCB, Valeant Pharmaceuticals North America LLC; and a speaker for AbbVie, Celgene, Novartis, Regeneron, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America LLC.
Other authors report no relevant financial relationships.
References
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2. Mrowietz U, Kragballe K, Reich K, et al. Definition of treatment goals for moderate to severe psoriasis: A European consensus. Arch Dermatol Res. 2011;303(1):1-10. doi: 10.1007/s00403-010-1080-1
3. Jullien D, Prinz JC, Nestle FO. Immunogenicity of biotherapy used in psoriasis: The science behind the scenes. J Invest Dermatol. 2015;135(1):31-38. doi:10.1038/jid.2014.295
4. Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-293. doi:10.1016/j.jaad.2018.03.040
5. Lebwohl MG, Sugarman JL, Gold LS, 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. doi:10.1016/j.jaad.2018.09.002
6. Fitch E, Harper E, Skorcheva I, Kurtz SE, Blauvelt A. Pathophysiology of psoriasis: Recent advances on IL-23 and Th17 cytokines. Curr Rheumatol Rep. 2007;9(6):461-467.
7. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): Results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661. doi:10.1016/S0140-6736(18)31713-6
