Clinical Insights Into the Topical Treatment of Psoriasis
Topical therapy plays an essential role in the treatment of psoriasis when used alone or even when patients are on systemic therapy. Clinical considerations for the use of topical therapy in plaque psoriasis were discussed at the 2023 Fall Clinical Dermatology Conference.
Following these proceedings, featured expert Bruce E. Strober, MD, PhD, was interviewed by Conference Reporter Medical Writer Rick Davis. Dr Strober’s clinical perspectives on this topic are presented here.
Topical therapy plays an essential role in the treatment of psoriasis. For many patients, initial treatment decisions after a diagnosis of psoriasis will include discussions regarding the use of topical and/or systemic therapy. However, even patients on systemic therapy will likely continue to use some topical agents, and topical therapy may be used to provide symptomatic relief. In some instances, effective topical therapy can reduce the doses of systemic drugs, but this is not a universally agreed upon goal of topical therapy. Most biologic medications, for instance, have fixed doses that should not be altered.
The mainstay of topical therapy for psoriasis is still topical corticosteroids, likely because of their generic status, low cost, and relative ease of access at the pharmacy level. However, their continued use can be laden with issues, including long-term adverse events and eventual loss of treatment response. Patients with plaque psoriasis may also be prescribed topical vitamin D analogues such as calcipotriene and calcitriol. They are also easily accessible topicals but are of lower potency than topical corticosteroids. A variety of other topical agents may also be considered in patients with psoriasis and are generally used only for the face and intertriginous areas. Because adherence to topical therapy can be a substantial clinical challenge, keeping the treatment regimen simple and using treatment vehicles that the patient finds acceptable are often the most beneficial approach.
The newer nonsteroidal topical therapies that are now approved by the US Food and Drug Administration for the treatment of psoriasis include tapinarof and roflumilast. They have different mechanisms of action from the previously available agents. Tapinarof is an AhR-modulating agent. Roflumilast is a PDE4 inhibitor. Based on available clinical trial data, there appears to be similar clinical efficacy with these 2 once-daily topical medications over the course of 8 to 12 weeks of treatment, as discussed at the 2023 Fall Clinical Dermatology Conference in presentations from Bunick and colleagues and Del Rosso and colleagues. Because both options are nonsteroidal, patients could potentially use them long-term without the known side effects of steroids. That is a real clinical benefit.
Some patients who are taking tapinarof after achieving disease clearing may maintain that clearance for a period of time after the discontinuation of therapy. So, it can have a remittive effect. On the other hand, tapinarof has demonstrated a folliculitis-like adverse effect that occurred in approximately 20% of patients in phase 3 trials. It is a keratosis pilaris–like outbreak that can occur not only on the areas where the topical has been applied but also on other parts of the body—sometimes distant areas.
In clinical trials, roflumilast has not demonstrated this folliculitis effect. One of the most common side effects found in clinical trials with roflumilast is diarrhea, and this is seen in approximately 3% of patients in the phase 3 trials. If any systemic absorption occurs with a PDE4 inhibitor, particularly this type of PDE4 inhibitor, we expect to see adverse events such as diarrhea because the drug is highly potent and highly selective, so the occurrence of this adverse event is not surprising.
One interesting development is that roflumilast is progressing toward approval of a new foam-based formulation, and this will hopefully be approved for not only psoriasis but also seborrheic dermatitis, which primarily affects the face and scalp. A foam-based formulation would be more spreadable and would allow ease of application to hair-bearing sites, which is something that can be challenging with creams.
Both of these drugs can be used on multiple parts of the body (eg, intertriginous areas, face, genitals, elbows, or knees). Their ability to be used on a wide area of the body, without the concerns that we have when using some other topical therapies, in my opinion, is a major paradigm shift in topical therapy for psoriasis. The targeted topical therapies that are entering our treatment armamentarium will give us more choices beyond corticosteroids for our patients. Making sure that all patients have access to these therapies will be key to ensuring optimal patient outcomes.
Bewley A, van de Kerkhof P. Engaging psoriasis patients in adherence and outcomes to topical treatments: a summary from the Symposium ‘Tailoring topical psoriasis treatments to patients’ needs and expectations’ of the 30th EADV Congress 2021. J Eur Acad Dermatol Venereol. 2023;37(suppl 1):9-13. doi:10.1111/jdv.18751
Bunick C, Bhatia N, Del Rosso J, et al. Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. Poster presented at: 2023 Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV.
Del Rosso JQ, Hong HC-ho, Kircik L, et al. Roflumilast cream 0.3% in patients with chronic plaque psoriasis: individual patient response from the pooled DERMIS-1 and DERMIS-2 phase 3 trials. Poster presented at: 2023 Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV.
Drakos A, Vender R, Torres T. Topical roflumilast for the treatment of psoriasis. Expert Rev Clin Immunol. 2023;19(9):1053-1062. doi:10.1080/1744666X.2023.2219897
Lebwohl MG, Kircik LH, Moore AY, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials. JAMA. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632
Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229. doi:10.1056/NEJMoa2103629
Nogueira S, Rodrigues MA, Vender R, Torres T. Tapinarof for the treatment of psoriasis. Dermatol Ther. 2022;35(12):e15931. doi:10.1111/dth.15931
Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: results from the PSOARING 3 trial. J Am Acad Dermatol. 2022;87(4):800-806. doi:10.1016/j.jaad.2022.06.1171
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