Andrew F. Alexis, MD, MPH: ADORING Trials, Tapinarof Cream, and Improving Skin of Color Research Representation

Andrew F. Alexis, MD, MPH

A new analysis from the pivotal phase 3 ADORING 1 and 2 clinical trials showed that a significantly greater proportion of patients to receive tapinarof cream 1% (VTAMA) were able to achieve 75% skin clearance for their eczema (EASI 75) versus a vehicle arm, regardless of skin color.¹

The data, presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego, CA, last week, was also highlighted for achieving an approximate 50% representation of atopic dermatitis patients with skin of color in the trial population.² What’s more, another 4 in 10 treated patients achieved clear skin per validated Investigators Global Assessment (vIGA) scores of 0.

In an interview with HCPLive during AAD 2024, trial author Andrew Alexis, MD, MPH, vice-chair for diversity and inclusion for the department of dermatology and professor of clinical dermatology at Weill Cornell Medical College, discussed the significance of the findings as they relate to the current state of clinical management of atopic dermatitis skin of color. Alexis additionally talked about what specific clinical and demographic challenges patients of color face in adequately treating chronic skin diseases, and what further steps may his peers take to further improve representation in research and care tailored to skin of color.

HCPLive: What are some of the key clinical differences we observe in skin of color affected by eczema?

Alexis: Atopic dermatitis (AD) impacts people across the diverse spectrum of skin types and racial/ethnic groups; however, there are variations in the epidemiology, clinical presentation, and impact of AD across diverse patient populations.

In the US, there is a higher prevalence of AD in Black children versus White children, and there are a number of racial/ethnic disparities in health care utilization, access, and impact of AD:

• Clinical nuances in AD among patients with skin of color include variations in erythema (which may have a violaceous, dark red-brown, or grayish hue depending on the skin type); follicular accentuation; papulonodular lesions; lichenoid morphology; and extensor involvement.
• Postinflammatory pigment alteration (hyper- or hypo-pigmentation) is a common sequela or associated feature of AD in patients with skin of color and contributes greatly to the psychosocial impact of the condition.
• Temporary hypopigmentation can also result from potent topical corticosteroids in patients with darker skin types.

HCPLive: What are some of the factors that which specifically limit the enrollment and participation of patients of color in dermatology clinical trials? And what effect does this have on our treatment outcomes in this population?

Alexis: Several barriers exist that disproportionately prevent individuals with skin of color from participating in clinical trials, including geographic distribution of trial sites, lack of awareness of relevant studies, language barriers and in some cases, general mistrust of research trials.

These factors contribute to the underrepresentation of these populations in clinical trials, leading to significant gaps in data and understanding regarding treatment efficacy in diverse groups.

This underrepresentation has prompted increased efforts to enhance the diversity within clinical trials to ensure the study populations more accurately mirror the real-world demographics of the U.S. Some of these efforts include raising awareness of trials in historically underserved communities, overcoming access barriers like language differences and travel distances to study sites, and rebuilding trust in research studies.

When studies enroll diverse patient populations—including those with skin of color—we are ultimately able to deliver better care by having data to support our treatment decisions across the diverse spectrum of patients that we see in our dermatology offices and clinics around the country.

HCPLive: What stands out to you as the most impactful finding from the ADORING data presented at AAD 2024? What do you derive from the significant disparities in skin color-related EASI outcomes?

Alexis: The findings from the ADORING clinical trial program highlight the ability of VTAMA (tapinarof 1%) cream, if approved by the U.S. Food and Drug Administration (FDA), to offer consistent and high efficacy across diverse populations 2 years of age and older with atopic dermatitis. With approximately 50% of the enrolled patients having skin of color, this study provides robust data supporting the safety and efficacy of tapinarofin this population, which has historically been underrepresented in clinical trials.

HCPLive:What are some feasible steps dermatology investigators and industry can begin taking right now to improve their representation in clinical trial populations?

Alexis: Increasing outreach and education efforts in communities of color to raise awareness about the value of clinical trials and the specific studies available. This can involve collaborating with community leaders, using local media and popular social media channels, and conducting educational workshops to demystify clinical research and address common concerns.

Clinical trial investigators can also help address logistical barriers to participation by offering solutions such as transportation assistance when needed, flexible scheduling and virtual study options (when possible) to accommodate the needs of a broader, more diverse population.

It’s also important to establish partnerships with healthcare providers serving diverse communities to facilitate clinical trial referrals and build trust.

Approaching the treatment of dermatologic diseases with empathy, cultural humility, and a commitment to providing the best care possible to all patients goes a long way to fostering inclusion of diverse populations in trials and patient care settings in general.

References

1. ^{Alexis A, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: An interim analysis of the open-label Phase 3b trial, ADmirable. Paper presented at: American Academy of Dermatology (AAD) 2024 Annual Meeting. March 8 – 12, 2024. San Diego, CA.}
2. ^{Kunzmann K. Tapinarof Cream Significantly Improves Atopic Dermatitis Regardless of Skin Color. HCPLive. Published March 10, 2024. https://www.hcplive.com/view/tapinarof-cream--improves-atopic-dermatitis-skin-color}