**Organon has shared positive results from a long-term extension (LTE) study of its Vtama (tapinarof) cream, 1% in atopic dermatitis (AD) patients aged as young as two years.**
Findings from the phase 3 48-week ADORING 3 trial, presented at this year’s American Academy of Dermatology (AAD) annual meeting, showed that disease activity remained mild in patients who achieved treatment success with the non-steroidal topical therapy and then entered into a treatment-free interval.
Commonly referred to as eczema, AD is one of the most common inflammatory skin diseases, affecting over 26 million people in the US alone. Patients can experience itchy, red, swollen and cracked skin, often on the folds of their arms, backs of their knees, hands, face and neck.
Vtama is an aryl hydrocarbon receptor agonist that received approval from the US Food and Drug Administration in December to treat AD in adults and children aged from two years.
Patients who entered ADORING 3 with completely clear skin or achieved this during the LTE, defined as a validated Investigator Global Assessment for AD (vIGA-AD) score of zero, stopped using Vtama and were assessed for maintenance of vIGA-AD scores of zero (clear) or one (almost clear) off-treatment. Those whose AD returned to a vIGA-AD score of two or higher (mild or above) were retreated until complete disease clearance was achieved again or until the study was completed.
At the end of the first treatment-free interval, which lasted for an average of 79.8 consecutive days, 84% of patients had a vIGA-AD score of two. Additionally, itch, which was evaluated with the patient reported Peak Pruritus Numerical Rating Scale, remained low and the mean Eczema Area and Severity Index score indicated mild disease.
Juan Camilo Arjona Ferreira, head of research and development and chief medical officer at Organon, said: “Knowing the profound impact that AD 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.”
Organon gained access to Vtama in October last year, when it completed its acquisition of Dermavant Sciences for approximately $1.2bn. Beyond AD, the drug also holds approvals to treat plaque psoriasis, an immune-mediated disease characterised by inflamed, scaly plaques that may be itchy or painful.