Clinical Trial Addresses the Lack of Diversity in Dermatology Research

One of the biggest blindspots in American medicine has been the underrepresentation of people of color in clinical trials. Dermatology research is no exception, and the clinical trials of psoriasis treatments have had some of the lowest rates of enrollment of nonwhite participants.

A new study, called VISIBLE, may help change that.

It is a first-of-its-kind, large-scale prospective study in designed specifically to understand and characterize moderate-to-severe plaque psoriasis in Black, Hispanic, Asian, Indigenous and other populations. A poster discussing the study was presented at the annual meeting of the American Academy of Dermatology Association in New Orleans.

Andrew F. Alexis, M.D., M.P.H., of Weill Cornell Medicine is leading the VISIBLE study that is designed to make up for the underrepresentation of people of color in psoriasis studies.

The study is on track to complete enrollment this spring, which is six months ahead of schdule, Andrew F. Alexis, M.D., M.P.H., the lead investigator and professor of clinical dermatology and vice-chair for diversity and inclusion at Weill Cornell Medicine in New York told Managed Healthcare Executive. Johnson & Johnson is sponsoring the study.

“Our hope is that the VISIBLE study design will not only create impact within the psoriatic disease space but will have much farther reach and impact in helping inform the broader dermatology research community to onstruct more diverse and inclusive studies with strategies to identify and enroll patients from underrepresented communities who face significant barriers to care," Alexis said.

Because of the issue of significant underrepresentation, there is still a pressing need for additional data for psoriasis treatments in people of color, including treatment endpoints that are specifically relevant to patients with skin of color, such as postinflammatory dyspigmentation, Alexis noted.

For example, although Tremfya (guselkumab) already has a well-established safety and efficacy profile across a broad patient population of adults with moderate-to-severe psoriasis from its pivotal clinical trials, the VISIBLE study is designed to provide additional clinically relevant data to inform the optimal care for people of color with psoriasis, said Alexis. Johnson & Johnon is the marketer of Tremfya.

“We designed VISIBLE to address lower enrollment for people of color in psoriasis studies, through a number of unique approaches, including appointment of a diverse steering committee of dermatologists involved in protocol development, community engagement and awareness building, educational and cultural training support for investigators, intentional site selection within diverse communities based on demographic data and a unique approach to confirm PsO (psoriasis) diagnosis to ensure enrollment isn’t restricted for eligible patients who may have barriers to accessing care,” he said.

He said the study aims to help raise awareness about the differences people of color with skin conditions. They want to raise awareness to help shorten time to diagnosis, support more accurate diagnosis in all skin types, promote earlier treatment and build trust with people of color.

The VISIBLE study will generate a collection of clinical photos across varying skin tones, across various ethnic/racial backgrounds that will help advance community, patient and healthcare provider education on how psoriatic disease presents and evolves in people of color. “We also plan on contributing beyond psoriatic disease, and help better educate on other disease space as well,” he said.

VISIBLE will evaluate efficacy, safety, impact on quality of life of Tremfya in about 200 people of color with moderate-to-severe plaque psoriasis over two years. The study will use a combination of objective and self-reported parameters to broaden inclusion of people of color from various backgrounds. Additionally, the study will assess post-inflammatory pigment alteration natural history and improvements over-time using combined objective colorimetry/clinician-/patient-reported outcomes, as well as assess genetic and comorbidity biomarkers relevant to people of color.