Raj Chovatiya, MD, PhD, and Adelaide A. Hebert, MD, FAAD, comment on the tolerability and low discontinuation rates of tapinarof for patients in AD clinical trials, as well as discuss the adverse events associated with the drug.
This is a video synopsis/summary of a panel discussion involving Raj Chovatiya, MD, PhD, and Adelaide A. Hebert, MD, FAAD.
The speaker addresses the crucial aspect of tolerability and safety in relation to tapinarof during clinical trials for atopic dermatitis. Emphasizing the significance of patient concerns about tolerability and safety, the speaker discusses the low incidence of treatment-related adverse events. Discontinuation rates for tapinarof were notably lower than the vehicle, ranging from 1.5% to 2%, suggesting a favorable safety profile and patient adherence to the therapy.
The discussion delves into three treatment-emergent adverse events of special interest: contact dermatitis, follicular events, and headaches. Despite the approval of tapinarof for psoriasis in patients aged 18 years and above, the speaker notes the careful consideration of previous psoriasis trial data when designing the atopic dermatitis trials. Contact dermatitis, at 1.5%, was surprisingly higher in the vehicle group. Follicular events, associated with psoriasis trials, were more prevalent in the tapinarof group, but the speaker underscores the manageable nature of mild folliculitis. Headaches, a common clinical trial occurrence, were more frequent in the tapinarof group without a clear explanation.
The speaker acknowledges the transparency in presenting the data, emphasizing the absence of an attempt to hide any information. Despite the challenges posed by follicular events and headaches, the overall low discontinuation rates indicate that these events did not significantly impact participants' ability to continue the therapy. The discussion concludes with a recognition of the need for further investigation into these adverse events, particularly the follicular events, and an emphasis on understanding patient profiles to glean more insights.
Video synopsis is AI-generated and reviewed by Dermatology Times editorial staff.