Data show most patients maintained mild disease for over two months without treatment following initial clearance in a 48-week extension trial.
Healthcare company Organon announced results from an analysis of its Phase 3 ADORING 3 open-label, long-term extension study evaluating VTAMA (tapinarof) cream, 1% once daily for treatment in adults and children 2 years of age and older with atopic dermatitis (AD), also known as eczema.
The findings demonstrate that AD disease activity remained mild in patients who had achieved treatment success and subsequently entered a treatment-free interval lasting on average 80 days.
“For patients with atopic dermatitis, the benefits of many topical treatments are often short-lived, and for some patients, their disease rapidly reappears after taking a break from topical treatments,” says Jonathan Silverberg, MD, PhD, MPH, George Washington University School of Medicine and Health Sciences, in a release. “As a physician, I’m encouraged that at the end of a break from treatment with VTAMA cream, patients’ AD remained mild. I’m excited to see these data support the use of VTAMA cream to potentially provide lasting results for itch, which is the universal and most burdensome symptom of AD.”
Study Details and Findings
ADORING 3 (N=728) was a 48-week open-label, long-term extension study that enrolled eligible patients from the pivotal Phase 3 ADORING 1 and ADORING 2 trials, patients from a four-week maximal usage pharmacokinetics study, and VTAMA cream-naive patients 2-17 years of age with either mild, moderate, or severe AD that did not meet inclusion criteria in ADORING 1 and ADORING 2.
In ADORING 3, those who entered with or achieved completely clear skin (n=378), defined as a validated Investigator Global Assessment for AD (vIGA-AD) score of 0, stopped using VTAMA cream and were assessed for maintenance of vIGA-AD of 0 (clear) or 1 (almost clear) off-treatment. Patients whose AD returned to a vIGA-AD of 2 or higher (mild or above) were retreated with VTAMA cream until complete disease clearance was achieved again or until study completion.
The new results demonstrate that, at the end of the first treatment-free interval, which lasted an average of 79.8 consecutive days, 84% of patients had a vIGA-AD score of 2 (mild). Itch, which was assessed with the patient-reported Peak Pruritus Numerical Rating Scale (PP-NRS) score ranging from 0 to 10, remained low with a mean weekly PP-NRS score of 2.9. The mean Eczema Area and Severity Index (EASI) score was 3.4, indicating mild disease.
The most frequent treatment-emergent adverse events (TEAEs) in ADORING 3 included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%); trial discontinuations due to TEAEs were low (2.6%). Adverse events of special interests including follicular events, contact dermatitis, and headache were mostly mild or moderate and associated with low discontinuation rates (1.0%, 0.4%, and 0%, respectively).
“These data reinforce the efficacy of VTAMA cream in atopic dermatitis, including the durability of effect among patients in the study, including children as young as two years old,” says Juan Camilo Arjona Ferreira, MD, head of research and development and chief medical officer at Organon, in a release. “Knowing the profound impact that atopic dermatitis can have on the lives of patients, and oftentimes their caregivers, the possibility to receive over two months of relief without needing to reapply treatment is meaningful and speaks to our mission of creating a healthier every day.”
In December 2024, the US Food and Drug Administration (FDA) approved VTAMA (tapinarof) cream, 1%, for the topical treatment of AD in adults and pediatric patients 2 years of age and older. VTAMA cream was also approved by the FDA on May 24, 2022, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults.
