• A new study from pharmaceutical company Janssen has announced a clinical trial of its biologic treatment Tremfya, a formulation of the drug guselkumab.
• The clinical trial, called VISIBLE, aims to expand psoriasis research in people of color, who’ve been traditionally underrepresented in that area of study.
• The historical lack of diversity in dermatology research has had a measurable negative impact on how people of color with skin condition such as psoriasis have been diagnosed and treated.

People of color have long been underrepresented in clinical studies, medical research, and education in the field of dermatology. A new study by Johnson & Johnson subsidiary Janssen is looking to expand psoriasis research in people of color. The company recently announced its plans for VISIBLE, a clinical trial that will study the safety and effectiveness of the biologic drug Tremfya — a formulation of guselkumab — in approximately 200 Black, Hispanic, Asian, Indigenous, and other people of color living with moderate to severe plaque and/or scalp psoriasis.

Tremfya is a biologic disease-modifying antirheumatic drug (DMARD) administered as a subcutaneous (under the skin) injection. Tremfya was approved by the U.S. Food and Drug Administration (FDA) in 2017 to treat moderate to severe plaque psoriasis and psoriatic arthritis.

The VISIBLE trial will “further evaluate the efficacy and safety of Tremfya (guselkumab) in people of color to generate additional data and provide valuable information about disease burden and the psoriatic disease patient journey in this population,” according to a press release from Janssen.

VISIBLE is part of Johnson & Johnson’s Our Race to Health Equity (ORTHE) efforts, dedicated to promoting diversity and improving research, care, and health equity for people of color. “By collecting additional safety, efficacy, biomarker, and disease progression data that are specific to people of color, we can put more information in the hands of health care providers and their patients so that, together, they can make the best treatment decisions,” said Dr. Andrew Alexis, a professor of clinical dermatology at Weill Cornell Medicine and principal investigator of the VISIBLE study.

Clinical Trials in Dermatology Lack Diversity

More than 80 million people in the United States are living with a skin-related disease. Of these, about 7.5 million people have psoriasis. A review of randomized dermatology clinical trials from 2010 to 2015 found that nearly 75 percent of study participants were white in trials that reported participants’ race. The same review noted that there was room for improvement when reporting the number of participants of color in dermatology trials in general.

A later review (from 2015 to 2020) showed a 12 percent increase — from 59.8 percent to 71.9 percent — in the number of studies reporting race and ethnicity. However, study populations in dermatology trials did not appear to become more diverse, with non-white participants holding steady at just over one-third of the total recruited. Moreover, studies on psoriasis were considered the least diverse, with a little more than 12 percent reporting at least one-fifth of participants as non-white.

How Lack of Diversity in Clinical Trials Affects Care and Outcomes for People of Color

Several challenges arise from the limited number of participants of color in clinical trials in dermatology. Here are the most prevalent issues and how they affect care.

Presentation and Diagnosis

The lack of diversity in clinical trials studying skin-related diseases has resulted in health care professionals having less available information for understanding, properly diagnosing, and treating conditions like psoriasis in people of color. In fact, psoriasis presents differently in people with darker skin. Erythema (patches of discolored skin) and thicker, scaly lesions on the skin appear differently in people of color than in white people.

Learn more about how signs of psoriasis can vary between skin tones.

In an episode of the National Psoriasis Foundation podcast “Psound Bytes,” Dr. Seemal Desai — a dermatologist at Innovative Dermatology in Plano, Texas — confirmed, "Diagnosing and treating psoriasis in skin of color can be a challenge for even the most astute dermatologists. And a lot of that lies in the fact that psoriasis in skin of color doesn't always follow the same morphologic and clinical clues as in lighter skin tones."

This can lead to incorrect diagnoses and untreated psoriasis and psoriatic arthritis for those with darker skin tones.

Disparities in Treatment and Severity

People of color often experience delays in treatment due to lack of understanding among health care providers in how psoriasis presents on a variety of skin tones. In fact, misdiagnosis of psoriasis in people with darker skin is more prevalent than in those with lighter skin.

Doctors who are unfamiliar with how psoriasis presents in people with darker skin often mistake psoriasis for hyperpigmentation, a usually harmless condition where some areas of a person’s skin take on a different color. This misdiagnosis can lead to delayed care and greater disease severity.

Dr. Desai said, “In my practice, my patients with psoriasis skin of color, in general, tend to come in when the disease is more moderate to severe.”

“Many of our patients in our skin-of-color and underrepresented communities don’t even know what psoriasis is,” Dr. Desai said. “They’ve never been to a board-certified dermatologist, a skin-of-color expert, or a psoriasis expert. They’ve never even heard of the disease. And so, a lot of times, many of my patients come in and have been told for years, ‘Oh, it’s just dry skin,’ or ‘It’s just flaky skin,’ or ‘It’s ashy skin.’ I hear all of those terms, and a lot of times when these patients do come to see me, they’re dealing with more severe disease because they haven’t been treated or addressed early on."

When it comes to treatment, many people of color only receive treatment with topical medications for their skin conditions, while others may not be treated at all. They may also lack access to more powerful drugs that could improve their condition. Panelists at the 2022 American Academy of Dermatology Annual Meeting shared that Black people living with psoriasis are almost 70 percent less likely to be treated with a biologic.

Learn more about biologics for psoriasis.

Quality of Life and Health Outcomes

The impact of psoriasis on quality of life and poor health outcomes is also greater for people of color. A study by the National Psoriasis Foundation looked at the psychosocial impacts on 4,725 participants with psoriasis. Nearly three-fourths of non-white participants noted that psoriasis impacted their quality of life, compared to 54 percent of white respondents.

Participants reported feeling self-conscious, embarrassed, angry, frustrated, and helpless. Dr. Desai noted, “I do think that my patients with psoriasis and skin of color have more psychological impact because I’ve seen that in my practice on a daily or weekly basis.”

With delayed treatment and misdiagnoses, many people of color deal with more severe psoriatic disease, which leads to more complications.

Underrepresentation in Training

The lack of diversity can also be seen in dermatology classrooms and clinics. A recent review of dermatology literature showed that an average of 81 percent of images in major dermatology textbooks depicted light or white skin. One study reviewed various types of training materials and found that only 14.9 percent of the 1,123 images of dermatologic lesions in textbooks, medical school curriculum, and internet materials were of skin of color.

In addition, dermatology is considered the second least diverse specialty in medicine, making it less common for people of color living with psoriasis to be treated by physicians who look like them and who fully understand the challenges they face.

As more researchers, educators, and health care providers become aware of the lack of race-related data in the treatment of psoriasis, there is an increasing demand for greater diversity in training materials and clinical studies.

Dr. Alexis, the principal investigator of the VISIBLE study, said, “There are racial and ethnic variations in the prevalence, quality of life impact, and clinical presentation of psoriasis. Limited research data, gaps in medical education, and access barriers to advanced treatments may also contribute to health care disparities in populations with skin of color, so it is imperative that we have more diverse representation in clinical studies.”

Talk With Others Who Understand

MyPsoriasisTeam is the social network for people living with psoriasis and psoriatic arthritis and their loved ones. On MyPsoriasisTeam, more than 105,000 members come together to ask questions, give advice, and share their stories with others who understand life with psoriatic disease.

Are you a person of color who has experienced disparities in treatment or an impact on your quality of life due to psoriasis? Share your experience in the comments below, or start a conversation by posting on your Activities page.