Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials.

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes. Patients received Tapinarof or vehicle cream QD for 8 weeks.

Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children.

Introduction: Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with AD. Here, we evaluate patient-reported outcomes (PROs), including family impact, with tapinarof in ADORING 1 and 2.

Treat-to-Target Outcomes With Tapinarof Cream 1% in Phase 3 Trials for Plaque Psoriasis.

The National Psoriasis Foundation (NPF) treatment targets aim to achieve 1% or lower body surface area (BSA) affected after 3 months of treatment. European psoriasis treatment guidelines aim to achieve similar goals based on improvements in Psoriasis Area and Severity Index (PASI) scores. We performed pooled analyses of the PSOARING phase 3 program, which evaluated treat-to-target outcomes for patients treated with tapinarof cream 1% once daily (QD) for up to 52 weeks.

Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis.

Introduction: Patients with psoriasis report pruritus as their most bothersome symptom. Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild to severe plaque psoriasis in two 12-week trials: PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980). Here, we present patient-reported pruritus outcomes from these trials.

Tapinarof cream 1% once daily for the treatment of plaque psoriasis: Patient-reported outcomes from the PSOARING 3 trial.

Background: Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in two 12-week, phase 3 pivotal trials in adults with mild-to-severe plaque psoriasis.

Objective: To assess long-term, health-related quality of life and patient satisfaction with tapinarof.

Methods: Patients completing the 12-week trials were eligible for 40 weeks of open-label tapinarof based on Physician Global Assessment score in PSOARING 3, with a 4-week follow-up.

One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial.

Background: Tapinarof cream 1% once daily, an aryl hydrocarbon receptor-modulating agent, was significantly more efficacious than vehicle and well tolerated in two 12-week phase 3 trials in adults with mild to severe plaque psoriasis.

Objective: To assess long-term safety, efficacy, remittive effect, durability of response, and tolerability of tapinarof.

Methods: Patients completing the 12-week trials were eligible for 40-weeks' open-label treatment and 4-weeks' follow-up.

Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis.

Background: Tapinarof cream is a topical aryl hydrocarbon receptor-modulating agent under investigation for the treatment of psoriasis. Tapinarof modulates the expression of interleukin-17 and the skin-barrier proteins filaggrin and loricrin.

Methods: We conducted two identical phase 3 randomized trials of tapinarof in patients with mild-to-severe plaque psoriasis.

Development and Content Validation of Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) in Adolescents and Adults with Moderate-to-Severe AD.

Introduction: Most patient-reported outcome (PRO) instruments that measure atopic dermatitis (AD) symptoms do not have sufficient documented evidence of content validity to satisfy regulatory agency guidance for inclusion in product-labelling claims in the USA or Europe. The objective of this study was to develop a PRO instrument in accordance with regulatory agency guidance to assess daily AD symptoms during the course of therapy and to establish its content validity and psychometric properties.

Methods: The Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) daily diary was developed based on qualitative interviews with US adolescents and adults with mild-to-severe AD.

Tapinarof in the treatment of psoriasis: A review of the unique mechanism of action of a novel therapeutic aryl hydrocarbon receptor-modulating agent.

Tapinarof, a novel, first-in-class, small-molecule topical therapeutic aryl hydrocarbon receptor (AhR)-modulating agent, is in clinical development for the treatment of psoriasis and atopic dermatitis. The efficacy of tapinarof in psoriasis is attributed to its specific binding and activation of AhR, a ligand-dependent transcription factor, leading to the downregulation of proinflammatory cytokines, including interleukin 17, and regulation of skin barrier protein expression to promote skin barrier normalization. AhR signaling regulates gene expression in immune cells and skin cells and has critical roles in the regulation of skin homeostasis.

Efficacy and patient-reported outcomes from a phase 2b, randomized clinical trial of tapinarof cream for the treatment of adolescents and adults with atopic dermatitis.

Background: Tapinarof is a topical therapeutic aryl hydrocarbon receptor modulating agent under investigation for atopic dermatitis (AD) and psoriasis treatment.

Methods: A phase 2b, double-blind, vehicle-controlled study randomly assigned adolescents and adults with AD to receive tapinarof cream 0.5%, 1%, or vehicle, once or twice daily, for 12 weeks with a 4-week follow-up.

A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes.

Background: Tapinarof cream is a topical therapeutic aryl hydrocarbon receptor modulating agent under investigation for treatment of psoriasis and atopic dermatitis.

Methods: In a phase 2b, double-blind, vehicle-controlled study, adults with plaque psoriasis were randomized to tapinarof cream 0.5% or 1% once or twice daily or vehicle once or twice daily for 12 weeks with 4-week follow-up.

Evaluating the Efficacy of Crisaborole Using the Atopic Dermatitis Severity Index and Percentage of Affected Body Surface Area.

Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis. This post hoc analysis pools results from 2 phase 3 studies (ClinicalTrials.gov, NCT02118766 [AD-301]; NCT02118792 [AD-302]) to evaluate crisaborole efficacy in patients ≥ 2 years with mild-to-moderate atopic dermatitis (per Investigator's Static Global Assessment) using the Atopic Dermatitis Severity Index (ADSI) and percentage of treatable body surface area (%BSA).

Topical Agents for the Treatment of Atopic Dermatitis.

Approval of the new topical phosphodiesterase 4 inhibitor crisaborole ointment, 2%, to treat mild-to-moderate atopic dermatitis (AD) warrants careful consideration of available efficacy and safety data for topical therapies to contribute to a better understanding of the role of crisaborole in the treatment of mild-to-moderate AD. A literature review was conducted to identify results of randomized, blinded, vehicle-controlled trials of topical agents for the treatment of AD published from January 1, 1997 to April 30, 2018. This review summarizes the efficacy and safety data of topical therapies including corticosteroids, calcineurin inhibitors, and crisaborole and it shows that comparison among available agents is difficult because of differing methodologies used across clinical trials and that there is considerable variability in safety reporting among AD trials.

Epidemiology, Diagnosis, and Treatment of Atopic Dermatitis in the Developing Countries of Asia, Africa, Latin America, and the Middle East: A Review.

Atopic dermatitis (AD), the leading cause of skin-related burden of disease worldwide, is increasing in prevalence in developing countries of Asia, Africa, Latin America, and the Middle East. Although AD presents similarly across racial and ethnic groups as chronic and relapsing pruritic eczematous lesions, some features of the disease may be more or less prominent in patients with darker skin. Despite a similar presentation, consistent diagnostic criteria and consistent treatment guidelines are lacking.

Burden of atopic dermatitis in Asia.

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense pruritus and eczematous lesions. It is considered one of the most common chronic conditions, with an estimated global prevalence of nearly 230 million. As in the rest of the world, prevalence of atopic dermatitis has been increasing in Asian countries over the last few decades.