FDA OKs Tapinarof Cream, 1% for Atopic Dermatitis In Patients Aged 2 Years and Older: Daily Dose

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On December 16, 2024, we reported on on the US FDA approval of tapinarof cream, 1% (Vtama; Organon) for patients aged 2 years and older with atopic dermatitis (AD).

The approval

The FDA's decision is supported by positive data stemming from the phase 3 ADORING 1 and 2 studies, a pharmacokinetics trial in children, and interim results from the ongoing ADORING 3 trial.

The ADORING 1 and ADORING 2 twin trials evaluated the efficacy and safety of tapinarof cream, 1%, in adults and children as young as 2 years old with moderate to severe AD. The endpoints were achieved by close to half of participants in each study, ie, in ADORING 1 by 45.4% and in ADORING 2 by 46.4% compared with 18% of participants treated with vehicle (P <.001).

ADORING 3 was a 48-week open-label, long-term extension (LTE) study and enrolled participants from the ADORING 1 and 2 trials, the 4-week maximal usage pharmacokinetics study, and tapinarof cream-naive children aged 2 to 17 years with either mild, moderate or severe AD that did not meet inclusion in the earlier studies. Slightly more than one-half (51.9%) entered with complete disease clearance or achieved that status at least once during the 48 weeks. Among those 378 participants, the average length of the first treatment-free interval was approximately 80 consecutive days—or, nearly 3 months. For any participant whose condition returned to a vIGA-AD score of 2 or higher, tapinarof treatment was reintroduced until they achieved complete disease clearance again or the study concluded. Researchers reported that the tapinarof safety profile with long-term use in ADORING 3 was consistent with the profile seen at week 8.

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