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Patient Baseline Characteristics in AD Tapinarof Clinical Trials

Opinion
Video

Expert dermatologists highlight the patient characteristics in the ADORING 1 and ADORING 2 trials, both focusing on tapinarof for the treatment of AD.

This is a video synopsis/summary of a panel discussion involving Raj Chovatiya, MD, PhD, and Adelaide A. Hebert, MD, FAAD.

The transcript discusses key aspects of a clinical trial, focusing on the design, patient demographics, and safety considerations for tapinarof in the treatment of atopic dermatitis. The limitations of assessing itch severity in younger individuals are acknowledged, but the speaker notes that data from older children, less than 12 years old, is reasonably reliable.

The strength of the trial lies in its balanced enrollment across age groups, addressing a common issue where trials claiming approval for various age ranges often have limited representation in younger cohorts. The pediatric dermatologist emphasizes the significance of FDA approval for pediatric indications, making a drug appealing to both pediatric and adult populations, thereby increasing the likelihood of insurance coverage.

The discussion highlights the trial's robust enrollment, particularly emphasizing the challenges of convincing parents to participate, even with the requirement for blood work. However, the rapid improvement observed in children using tapinarof fosters commitment to the study. The inclusion of a diverse patient population, reflective of the demographics of the U.S., is praised, acknowledging the commitment of pharmaceutical companies, the FDA, and the NIH (National Institutes of Health) to promote diversity in clinical trials.

The average age of participants, around 15 or 16, is noted, with a good balance in gender and reasonable BMI numbers, indicating a focus on younger individuals. The distribution of age groups in the trial, with a substantial representation of those under 18, is highlighted as a positive aspect. The racial diversity of the participants is also commended as closely aligning with the demographics of the U.S.

The transcript concludes with a discussion on the safety profile of tapinarof, citing data from a maximum use study that reassures about its systemic concentration. The expectation is that, following FDA approval, tapinarof may not necessitate ongoing lab work, making it a safe topical option, particularly beneficial for moderate to severe patients who typically require regular monitoring for many drugs.

Video synopsis is AI-generated and reviewed by Dermatology Times editorial staff.

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