The Janssen Pharmaceutical Companies of Johnson and Johnson have announced the initiation of VISIBLE, a reportedly first-of-its-kind large-scale clinical study aimed at examining inequities in care among patients of color living with moderate to severe plaque or scalp psoriasis.
According to the company, psoriasis impacts more than 8m people in America living with the disease and can take) can take a physical, psychological, and emotional toll on such patients—especially those from non-white racial groups. In addition to challenges associated with limited medical research and education, as well as underrepresentation in clinical studies, it can present with less-noticeable skin reddening on darker skin tones, making it harder to identify and easier to misdiagnose.
The company reports the VISIBLE study will evaluate the efficacy and safety of Tremfya (guselkumab) in people of color to generate additional data and provide information about disease burden and the psoriatic disease journey among patients from this population. Tremfya reportedly has an established safety and efficacy profile across a broad patient population of adults with moderate to severe psoriasis, but there is still a need for more data in non-white patients, especially considering the majority of studies have enrolled a predominantly white patient population.
"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 healthcare disparities in populations with skin of color, so it is imperative that we have more diverse representation in clinical studies," said Andrew Alexis, professor of clinical dermatology and vice-chair for diversity and inclusion at Weill Cornell Medicine in New York and lead study investigator. "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 healthcare professionals and their patients so that, together, they can make the best treatment decisions."
Biologics are a class of prescription treatments that block specific parts of the immune system responsible for inflammation and causing plaque psoriasis and its symptoms when overactive in the body. Biologics have been increasingly used over the course of the past 20+ years to treat autoimmune disease patients.
According to company representatives, the VISIBLE study findings (along with other industry efforts to address education and research gaps in dermatology) will help foster a greater understanding of how biologic treatment may help improve health outcomes in people of color living with moderate to severe plaque and/or scalp psoriasis.
Additionally, Janssen is partnering with community health centers, retail clinics, and local and national organizations to support communities in raising disease awareness and reducing potential obstacles to clinical study enrollment. Because psoriasis presents differently in people of color, the company is offering training support for study investigators and taking a unique approach to confirm a diagnosis.
What’s more, the VISIBLE study will endeavor to generate a collection of clinical photos across varying skin tones that will help advance patient and healthcare provider education on how psoriatic disease presents in people of color.
"We are proud to be working to set a new standard where diversity in clinical studies is both expected and necessary to relentlessly advance care for all patients who carry the burden of disease as we continue to confront underrepresentation in clinical research," said David Jimenez, president of Janssen Immunology, Janssen Biotech. "Janssen is committed to supporting providers in their efforts to connect with their patients on a more personal level, better meet individual patient needs, and ensure optimal care that helps alleviate inequities in their healthcare."