“In psoriasis, we have a significant need for effective topical therapies that do not restrict the amount of time we can apply them or the locations on the body where we can apply them,” stated Prof. Mark Lebwohl (Icahn School of Medicine at Mount Sinai, USA) [1]. He referred to restrictions of high-potent topical corticosteroids that cannot be used, for example, in the face or intertriginous sites.
Tapinarof is a first-in-class, non-steroidal topical aryl hydrocarbon receptor-modulating agent, which moderates pro-inflammatory pathways implicated in psoriasis (i.e. IL-17A, IL-17F) and atopic dermatitis (i.e. IL-4, IL-5, IL-13). “Tapinarof enters the cell where it binds to the aryl hydrocarbon receptor. That complex then enters the nucleus where it joins with the aryl hydrocarbon receptor nuclear translocator and that entire complex regulates gene expression, resulting in a reduction in inflammatory cytokines and an increase in barrier proteins,” Prof. Lebwohl explained the mode of action.
Tapinarof was evaluated in the identical multicentre PSOARING 1 (PSO1; NCT03956355) and PSOARING 2 (PSO2; NCT03983980). The studies included a total of 1,025 adults with a mean age between 49.1 and 50.0 years, the proportion of males was 50.6% and 62.2%, the mean weight was 89.6 kg and 92.9 kg, and the participants had a Physician Global Assessment (PGA) of 2-4, respectively. Roughly 80% had moderate disease and almost 10% mild or severe psoriasis, respectively. The mean Psoriasis Area Severity Index (PASI) ranged from 8.7 to 9.3. In both trials, patients were randomised 2:1 to either tapinarof 1% or vehicle once daily. The primary endpoint was a PGA response of 0 or 1 with a ≥2-grade improvement at week 12.
In PSO1 and PSO2, 35.4% and 40.2% in the tapinarof group achieved this PGA goal versus 6.0% and 6.3% in the vehicle group (P<0.0001 for both comparisons). At week 12, the results for the key secondary endpoint, defined as the rate of patients with PASI 75, were similar: 36.1% and 47.6% in the tapinarof group versus 10.2% and 6.9% in the vehicle group with again P<0.0001 for both differences.
The safety parameters of PSO1 and PSO2 were in line with previous studies [3,4]. Most adverse events (AEs) were mild or moderate in severity with a low study discontinuation rate due to AEs of 5.6% and 5.8% in PSO1 and PSO2 [1]. The most common treatment-related AEs were folliculitis, contact dermatitis, headache, and pruritus.
“Tapinarof has the potential to be a first-in-class topical therapeutic aryl hydrocarbon receptor modulating agent and will provide physicians with a novel non-steroidal topical treatment option that is highly effective and well-tolerated,” Prof. Lebwohl concluded.
- Lebwohl M, et al. Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Efficacy and Safety in Two Pivotal Phase 3 Trials. D3T03.3D, EADV 2020 Virtual Congress, 29-31 Oct.
- Menter A, et al. J Am Acad Dermatol. 2009;60:643-59.
- Robbins K, et al. J Am Acad Dermatol. 2019;80:714-721.
- Gold SL, et al. J Am Acad Dermatol. 2020 May 21: S0190-9622(20)30957-9. DOI: 1016/j.jaad.2020.04.181.
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Table of Contents: EADV 2020
Featured articles
Late-Breaking News
Selective IL-23 blocker shows potential in psoriasis treatment
Promising results with nanobody treatment in psoriasis
Light at the end of the tunnel for chronic hand eczema
Epidermolysis bullosa: Novel wound treatment on the horizon
Efficacious non-steroidal topical for psoriasis
Oral JAK 1 inhibitor leads to fast itch relieve and remarkable skin clearance in AD
COVID-19: What Dermatologists Need to Know
Biologic psoriasis treatment and COVID-19 risk: Contradictory results
Much to be learned about COVID-19 and the skin
JAK Inhibitors – A Fascinating Novel Drug Class
JAK inhibitors in AA: re-establishing the immune privilege of hair follicles
JAK1 inhibition successful in hidradenitis suppurativa
Topical JAK inhibition: a novel treatment option for patients with mild-to-moderate AD
Urticaria – What’s new
Chronic inducible urticaria can require some detective work
Chronic spontaneous urticaria: hives, wheals & biomarkers
Ligelizumab for chronic spontaneous urticaria: a new star on the horizon
Infectious Diseases: Novel Developments
Bacterial resistance in skin infections – a challenging threat
Borreliosis: A multifaceted disease
Scabies – A global health challenge
Upcoming Treatments
Meaningful sleep improvement with IL-13 inhibition
Preventing foot odour with zinc oxide coated socks
Baricitinib in AD: Efficacy paired with consistent long-term results
Best of the Posters
Real-world data on brodalumab affirms efficacy and fast onset of action
Heightened risk for psychiatric comorbidities in hidradenitis suppurativa patients
Effects IL-13 blocker improves with longer treatment duration
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December 18, 2020
Letter from the Editor
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