The psoriasis treatment landscape keeps changing for the better, with newer injectable and topical therapies available for patients with mild, moderate, and severe disease. Within the past 2 years alone, the FDA has approved some new indications for already existing therapies and new topical formulations.
In April 2019, a new formulation of halobetasol proprionate and tazarotene lotion 0.01%/0.045% (HP/TAZ;) was approved by the FDA.1 The advantage of this formulation is that it combines two older, but effective, psoriasis therapies—tazarotene and halobetasol (in lower concentrations than we currently have available)—into one topical using an elegant, high-tech vehicle. This gives our patients the best of both worlds. The new vehicle suspends these active ingredients in a moisturizing emulsion that reduces irritation associated with tazarotene while allowing for long-term use (up to 24 weeks of continuous use and 52 weeks as needed) of the topical steroid halobetasol without the risk of adverse events, such as stretch marks and skin thinning.2 In other words, this new option improves the efficacy of these two medications while minimizing their separate adverse effects. HP/TAZ lotion, with its lower concentration of active ingredients, was also found to be as effective as the higher strength, commercially available halobetasol.3 This therapy is particularly helpful for patients with thick plaques who may need more than 2 to 4 weeks of topical treatment to improve.
In March 2020, the FDA approved the expanded indication of ixekizumab for the treatment of pediatric patients aged 6 years or older.4 This is the first IL-17 to receive approval for pediatric patients. This approval not only gives us another option for pediatric patients beyond the use of certain FDA-approved tumor necrosis factor (TNF) inhibitors, but it adds another layer of safety and security for all of our patients, including adults. Even more recently, the European Union approved secukinumab for pediatric patients with psoriasis aged 6 years and older; the FDA approval for secukinumab to treat pediatric psoriasis is currently pending.5 In addition, ustekinumab was approved for pediatric patients in late July.6
Guselkumab also received approval for adult psoriatic arthritis (PsA) at the same dose approved for psoriasis in July 2020 and is the first IL-23 to be approved for this indication.7 This approval is an interesting one because IL-23 was not originally considered an effective treatment for PsA. However, the clinical trial data showed a greater percentage of participants in both studies achieved the primary end point (20% improvement in the American College of Rheumatology score) compared with placebo.8,9 The psoriasis dosing in PSA trended toward significant inhibition of structural damage of joint disease at week 24 vs placebo and less radiographic progression of joint disease through week 52. The approval of guselkumab opens up new thinking about the process and possible therapeutic options for the treatment of PsA.
Lastly, a new formulation of calcipotriene and betamethasone dipropionate was approved in late July 2020.10 This new formulation is exciting because it takes an established topical psoriasis therapy and uses a less greasy cream vehicle instead of the ointment. Additionally, the clinical trial data showed that the cream formulation was more effective than the ointment formulation, with a 14.6% difference in treatment success in favor of the cream formulation.11
Patients with psoriasis have more safe and effective treatment options than ever before, and our armamentarium will only continue to grow as more therapies in the pipeline are approved. In addition to being able to effectively treat psoriasis, we are also learning about how these treatments could possibly improve patients’ comorbidities and quality of life. Kristi Hawley, DO, contributing author for The Dermatologist’s Psoriasis Center of Excellence, has covered our understanding of the links between psoriasis and various comorbidities in her Psoriasis and Comorbidity Series, including obesity, diabetes, and cardiovascular disease.12,13 April Armstrong, MD, was featured in our podcast series Pearls in Psoriasis, where she discussed the impact of mental health on patients with psoriasis and their satisfaction with physicians (you can preview an excerpt of her episode on page 25).14
Thus far in 2020, we have seen some amazing advances, both approved and in the pipeline, for psoriasis. The next step for us is a cure. n
Dr Green is clinical professor of dermatology at George Washington University School of Medicine & Health Scieinces in Washington, DC.
Disclosure: Dr Green is an investigator, speaker, and/or consultant for Ortho Dermatologics, Eli Lilly and Company, Novartis, Janssen, and MC2 Therapeutics.
References
1. FDA approves Bausch Health’s Duobrii (halobetasol propionate and tazarotene) lotion o.01%/0.045% for plaque psoriasis in adults. News release. Bausch Health Companies Inc; April 25, 2019. Accessed August 3, 2020. https://www.prnewswire.com/news-releases/fda-approves-bausch-healths-duobrii-halobetasol-propionate-and-tazarotene-lotion-0-010-045-for-plaque-psoriasis-in-adults-300838534.html
2. 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
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. Lilly’s Taltz (ixekizumab) receives U.S. FDA approval for the treatment of pediatric patients with moderate to severa plaqye psoriasis. News release. Eli Lilly and Company; March 30, 2020. Accessed August 3, 2020. https://www.prnewswire.com/news-releases/lillys-taltz-ixekizumab-receives-us-fda-approval-for-the-treatment-of-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-301031305.html
5. Novartis Cosentyx receives EU approval for first-line systemic treatment in pediatric psoriasis. News Release. Novartis; August 3, 2020. Accessed August 4, 2020. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-eu-approval-first-line-systemic-treatment-pediatric-psoriasis
6. U.S. Food and Drug Administratino approves STELARA® *ustekinumab) for treatemtn of pediatric patients with moderate to severe plague psoriasis. News release. Janssen Pharmaceutical Companies; July 30, 2020. Accessed August 10, 2020. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-stelara-ustekinumab-for-treatment-of-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-301103505.html
7. Tremfya (guselkumab) approved by U.S. Food and Drug Administration as the first selective interleukin (IL)-23 inhibitor for active psoriatic arthritis. News release. Janssen Pharmaceutical Companies of Johnson & Johnson; July 14, 2020. Accessed August 3, 2020. https://www.prnewswire.com/news-releases/tremfya-guselkumab-approved-by-us-food-and-drug-administration-as-the-first-selective-interleukin-il-23-inhibitor-for-active-psoriatic-arthritis-301093009.html
8. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;369(10230):1115-1125. doi:10.1016/S0140-6736(20)30265-8
9. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136. doi:10.1016/S0140-6736(20)30263-4
10. MC2 Therapeutics announces U.S. Food and Drug Administration approval of Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for adults with plaque psoriasis. News release. MC2 Therapeutics; July 22, 2020. Accessed August 3, 2020. https://www.businesswire.com/news/home/20200722005313/en/MC2-Therapeutics-Announces-U.S.-Food-Drug-Administration
11. A clinical trial evaluating efficacy and safety of MC2-01 Cream. ClinicalTrials.gov
identifier: NCT03308799. October 29, 2019. Accessed July 23, 2020. https://clinicaltrials.gov/ct2/show/results/NCT03308799
12. Hawley K. The psoriasis and comorbidity series: an approach to cardiovascular risk. The Dermatologist. Published online March 3, 2020. Accessed August 3, 2020. https://www.the-dermatologist.com/article/psoriasis-and-comorbidity-series-approach-cardiovascular-risk
13. Hawley K. The psoriasis and comorbidity series: understand the link between psoriasis, diabetes, and obesity. The Dermatologist. Published online July 13, 2020. Accessed August 3, 2020. https://www.the-dermatologist.com/article/psoriasis-and-comorbidity-series-understanding-link-between-psoriasis-diabetes-and-obesity
14. Green L, Armstrong AW. Dr Armstrong on mental health, physician satisfaction, and psoriasis. Pearls in Psoriasis. July 10, 2020. Accessed August 3, 2020. https://www.the-dermatologist.com/news/pearls-psoriasis-dr-armstrong-mental-health-physician-satisfaction-and-psoriasis
