Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent

Strober, Bruce; Gold, Linda Stein; Bissonnette, Robert; Armstrong, April W.; Blauvelt, Andrew; Brown, Philip King; Kircik, Leon; Tallman, Anna M.; Lebwohl, Mark

doi:10.25251/skin.5.supp.35

Cited by 4 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Overall, a low incidence of AEs was reported across the trials and none was considered related to tapinarof. This is consistent with the safety profile observed in 18 tapinarof clinical trials in over 2200 participants, including the phase 2b psoriasis 15 and atopic dermatitis 7 trials, two 12-week pivotal psoriasis trials (PSOARING 1 and 2), 10 and the PSOARING 3 long-term extension trial, 11 in which tapinarof cream 1% QD was well tolerated and showed no increased risk of AEs with long-term use. 11 Notably, the dermal safety trials reported here found no evidence of drug sensitization.…”

Section: Discussionsupporting

confidence: 83%

“…This is consistent with the safety profile observed in 18 tapinarof clinical trials in over 2200 participants, including the phase 2b psoriasis 15 and atopic dermatitis 7 trials, two 12-week pivotal psoriasis trials (PSOARING 1 and 2), 10 and the PSOARING 3 long-term extension trial, 11 in which tapinarof cream 1% QD was well tolerated and showed no increased risk of AEs with long-term use. 11 Notably, the dermal safety trials reported here found no evidence of drug sensitization. In phase 3 pivotal trials conducted in adults with psoriasis, treatment-related TEAE of contact dermatitis was reported in 3.8% (PSOARING 1) and 4.7% (PSOARING 2) of adults receiving tapinarof cream 1%.…”

Section: Discussionsupporting

confidence: 83%

“…2,3 In adults with plaque psoriasis, tapinarof cream 1% QD demonstrated highly statistically significant and clinically meaningful efficacy in two identical, double-blind, randomized, controlled, phase 3 trials (PSOARING 1 and 2), 10 and a long-term, open-label, phase 3 trial (PSOARING 3). 11 A clinical program comprising 2 pivotal phase 3 trials (ADORING 1 and 2) and a long-term extension trial (ADORING 3) is planned to evaluate the safety and efficacy of tapinarof cream 1% QD in children and adults with AD.…”

Section: Discussionmentioning

confidence: 99%

“…[4][5][6][7] Tapinarof specifically binds to and activates the aryl hydrocarbon receptor, a ligand-dependent transcription factor with roles in the regulation of cytokine and skin barrier protein expression, and antioxidant activity. 4,8,9 The efficacy and safety of tapinarof cream 1% QD have been demonstrated in a comprehensive phase 3 psoriasis pivotal trial program (PSOARING 1, 2, and 3), 10,11 and are being further evaluated in a pivotal clinical trial program in adults and children with AD (ADORING 1, 2, and 3).…”

mentioning

confidence: 99%

See 3 more Smart Citations

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials

Jett¹,

McLaughlin²,

Wilson³

et al. 2022

JDD

View full text Add to dashboard Cite

Background: Tapinarof (VTAMA ® ; Dermavant Sciences, Inc.) is a novel, non-steroidal, topical, aryl hydrocarbon receptor agonist, FDA approved for psoriasis treatment and under investigation for atopic dermatitis treatment as a 1% cream formulation for once-daily (QD) application. Objective: Evaluate cumulative skin irritation, sensitization, and photoallergic and phototoxic potential of tapinarof cream 1% across a range of dosing frequencies and conditions. Methods: We conducted 4 randomized, controlled, phase 1 trials of topical tapinarof cream 1% vs vehicle or other appropriate controls in healthy adults. Cumulative skin irritation was assessed following QD application for 21 days under fully occlusive patch conditions. Contact sensitization, photoallergenicity, and phototoxicity were assessed under semi-occlusive patch conditions. The contact sensitization and photoallergenicity trials used an induction phase of repeated applications followed by a 2-week rest period and a 1-time challenge, with rechallenge if responses indicated sensitization/photosensitization; the phototoxicity trial comprised a single application. Ultraviolet A and B irradiation was used to assess photoallergenicity/toxicity. Results: 376 participants were randomized across the 4 trials. In the cumulative irritation trial, tapinarof cream 1% QD was classified as having a slight potential for very mild cumulative irritation under the exaggerated test conditions of repeated dosing for 21 days. There was no evidence of sensitization, photosensitization, or phototoxicity. Tapinarof was well tolerated and there was a low discontinuation rate across all trials. Conclusions: Tapinarof cream 1% was well tolerated, non-sensitizing, non-phototoxic, and non-photoallergic, with no evidence of clinically meaningful cumulative skin irritation in 4 dermal safety trials in healthy adults.

show abstract

Section: Discussionsupporting

confidence: 83%

Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials

Jett¹,

McLaughlin²,

Wilson³

et al. 2022

JDD

View full text Add to dashboard Cite

show abstract

New topical therapies for psoriasis

Buechler

Veenstra

Gold

2021

Dermatological Reviews

View full text Add to dashboard Cite

Background Psoriasis is a debilitating autoimmune condition that causes red scaly plaques of the skin with potential to produce systemic inflammation affecting multiple organ systems. While the majority of patients can be managed with topical therapy, no one topical medication is right for everyone, and the therapeutic armamentarium continues to expand with improved delivery vehicles and new active ingredients. This review will discuss recently approved and upcoming topical medications for psoriasis. Recent advances The past several years have seen the advent of novel lotion and cream vehicles as well as new options for spray or foam application, fixed‐dose combined medications, and nonsteroidal options. New corticosteroid topical monotherapies in improved vehicles include halobetasol propionate (HP) 0.05% foam, HP 0.01% lotion, clobetasol propionate 0.025% cream, and betamethasone dipropionate (BD) 0.05% spray. Fixed‐dose combination topical therapies include calcipotriene 0.005% plus BD 0.064% (Cal‐BD) foam, Cal‐BD cream, and HP 0.01% plus tazarotene 0.045% lotion. Numerous nonsteroidal offerings are poised to enter the market, most notably tapinarof 1% cream, roflumilast 0.3% cream, and roflumilast 0.3% foam. Summary Recent advancements in both delivery vehicles and medications available for topical treatment of psoriasis have the potential to allow better control of disease and increase treatment satisfaction among patients.

show abstract

Tapinarof Cream 1% for Extensive Plaque Psoriasis: A Maximal Use Trial on Safety, Tolerability, and Pharmacokinetics

et al. 2021

View full text Add to dashboard Cite

Background Tapinarof is a novel topical therapeutic aryl hydrocarbon receptor modulating agent in development for the treatment of psoriasis and atopic dermatitis. Objective This multicenter, open-label trial assessed the safety, tolerability, pharmacokinetics (PK), and efficacy of tapinarof cream 1% once daily (QD) under maximal use conditions in extensive plaque psoriasis. Methods Adults with a baseline Physician Global Assessment (PGA) score of ≥ 3 and body surface area (BSA) involvement ≥ 20% received tapinarof cream 1% QD for 29 days. Safety and tolerability assessments included adverse events (AEs) and local tolerability scales. PK parameters were calculated using non-compartmental analysis. Efficacy assessments included change in PGA, Psoriasis Area and Severity Index score, and %BSA affected. Results Twenty-one patients were enrolled. Common AEs were folliculitis, headache, back pain, and pruritus (none led to discontinuation). Tapinarof plasma exposure was low, with the majority of concentrations being below detectable limits. At day 29, 14 patients (73.7%) had a ≥ 1-grade improvement in PGA score and six patients (31.6%) had a ≥ 2-grade improvement; four patients (21.1%) achieved treatment success (PGA 0 or 1 and ≥ 2-grade improvement). Conclusion Tapinarof cream 1% QD was well tolerated, with limited systemic exposure and significant efficacy at 4 weeks in patients with extensive plaque psoriasis. ClinicalTrials.gov Identifier NCT04042103. Supplementary Information The online version contains supplementary material available at 10.1007/s40257-021-00641-4.

show abstract

Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent

Abstract: N/A

Cited by 4 publications

References 0 publications

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials

New topical therapies for psoriasis

Tapinarof Cream 1% for Extensive Plaque Psoriasis: A Maximal Use Trial on Safety, Tolerability, and Pharmacokinetics

Contact Info

Product

Resources

About