New phase 3 trial data was announced by Dermavant Sciences indicating strong results for both efficacy and safety of tapinarof treatment for atopic dermatitis.
Almost half of atopic dermatitis (AD) patients given tapinarof, 1% achieved improvement on the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM), according to a new assessment.1
In data that was announced by Dermavant Sciences, from the phase 3 ‘ADORING 2’ trial, investigators explored the efficacy and safety of topical tapinarof (VTAMA) cream, 1% for pediatric patients—as young as 2 years of age—and adults with AD.
“Atopic dermatitis can have a negative impact on the quality of life of diagnosed children as well as their families,” said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology of Rady Children’s Hospital in San Diego. “Both the efficacy and itch data from the ADORING 2 trial are highly encouraging in this regard, pointing to VTAMA cream as a potential non-steroidal topical treatment option for AD that is safe and well tolerated in children.”
The investigators noted that around half of patients who received VTAMA cream reported a response of either clear or almost clear. Additionally, they noted a 2-grade improvement from baseline on the Validated Investigator Global Assessment for Atopic Dermatitis at 8 weeks.
The research team’s findings for the drug were substantially higher than for those who were given a vehicle cream.
They also noted that tapinarof showed high statistical significance in all secondary endpoints, including a significant improvement in Eczema Area and Severity Index (EASI75) for 59.1% compared to 21.2% given the vehicle.
“When one considers this Phase 3 data alongside the recently reported pediatric maximal usage pharmacokinetic (MUPK) AD study, which in treated patients demonstrated minimal-to-no-systemic exposure despite heavy disease burden, (tapinarof) cream is positioning itself to be a potential two-in-one first-line topical treatment for both atopic dermatitis and plaque psoriasis,” said Linda Stein Gold, MD, Henry Ford Health System’s Director of Clinical Research and Division Head of Dermatology.
Those who used tapinarof were noted by the investigators as having had a substantial improvement in itch, measured by the Peak Pruritus Numeric Rating Scale.
Overall, the researchers noted that tapinarof cream was found to be both safe and tolerable in all age groups down to 2 years, with no reported safety or tolerability issues.
Additionally, any adverse events reported by patients were found to be mild or moderate, and there was a low study discontinuation rate due to treatment-emergent adverse events.
“The majority of patients diagnosed with atopic dermatitis suffer from severe itching and scratching resulting in skin redness, and damage to the skin barrier, which is why any effective therapeutic for AD needs to tackle the issue of pruritus, especially in a pediatric population,” stated Philip M. Brown, MD, JD, Dermavant’s Chief Medical Officer. “We now keenly anticipate topline data from our identically designed ADORING 1 trial in May 2023.”