Vtama cream results are ‘fully replicable’ in second of two phase 3 studies
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Key takeaways:
- 45.4% of children and adults receiving Vtama improved to clear or almost clear in validated IGA for atopic dermatitis response.
- 91% of phase 3 subjects elected to enroll in ADORING 3, an extension study.
The second of two phase 3 studies evaluating Vtama cream 1% in adults and children aged as young as 2 years with atopic dermatitis showed consistent safety and efficacy results, Dermavant Sciences announced in a press release.
Vtama (tapinarof) cream 1%, a nonsteroidal, aryl hydrocarbon receptor agonist, was approved by the FDA for adults with plaque psoriasis in May 2022. Since then, the drug has been evaluated for the treatment of AD in children and adults in two identical phase 3 studies, ADORING 1 and ADORING 2.
Following results from ADORING 2 that were announced in March, results from ADORING 1 have confirmed that Vtama cream 1% is safe, effective and well-tolerated among this population.
“The results are fully replicable,” Todd Zavodnick, CEO at Dermavant Sciences, told Healio. “ADORING 1 confirmed that we have a [supplemental new drug application]-ready product to submit in the first quarter of 2024.”
Consisting of 407 patients that received identical doses of the cream or vehicle once daily for 8 weeks, ADORING 1 achieved its primary and all secondary endpoints.
The primary endpoint, achieved by 45.4% of patients receiving Vtama cream, was a 0/1 (clear/almost clear) validated IGA for atopic dermatitis response with an improvement of at least two grades by week 8. In comparison, this was achieved by only 13.9% of those receiving vehicle cream (P < .0001).
Secondary endpoints were also achieved, according to the press release. This included 55.8% of Vtama-treated subjects vs. 22.9% of vehicle-treated subjects reaching EASI 75 (P < .0001).
Results also showed a significant improvement in itch, with 55.8% of patients aged 12 years or older treated with the study drug experiencing at least a 4-point reduction on the peak pruritus numerical rating scale compared with 34.2% of vehicle-treated subjects (P < .0366). Across the entire patient population, 61.1% of those patients treated with Vtama experienced this reduction in itch (P < .0001), according to the press release.
The study reported no safety or tolerability signals among patients, with more patients experiencing adverse events in the vehicle arm (3.6%) compared with the Vtama cream arm (1.9%).
At the end of the trial, 91% of participants from both ADORING 1 and ADORING 2 chose to continue treatment in Dermavant’s long-term safety study, ADORING 3, which will last 48 weeks.
“Patient satisfaction is really read in our rollover,” Zavodnick told Healio. “People do not want to leave this study.”
With Vtama being the No. 1 branded, psoriatic topical, Zavodnick added that the data is even better with AD when it comes to onset speed, efficacy, itch and safety.
“When looking at AD, 95% of the market is topical steroids,” Zavodnick said. “There is a lot of want from patients and their parents for a nonsteroidal option and we are going to work as fast and as hard as we can with the agency to see how soon we can get approval.”