Janssen Initiates First-of-its-Kind Clinical Study to Bridge Critical Gaps in Care for People of Color with Moderate to Severe Plaque Psoriasis

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color
Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities

Psoriasis (PsO) can take a physical, psychological, and emotional toll on the more than 8 million Americans living with the disease; and for people of color, there are additional challenges due to limited medical research and education, as well as underrepresentation in clinical studies.1,2,3 This has led to a lack of data and barriers to optimal care for diverse patient populations.2 PsO may also present with less noticeable skin reddening on darker skin tones, which can make it harder for healthcare providers to identify and lead to misdiagnoses in people of color. To help address these health inequities, the Janssen Pharmaceutical Companies of Johnson & Johnson today announced the initiation of VISIBLE, a first-of-its-kind, large-scale prospective clinical study dedicated to people of color living with moderate to severe plaque and/or scalp PsO.

VISIBLE 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. TREMFYA has a well-established safety and efficacy profile across a broad patient population of adults with moderate to severe PsO. However, there is still a pressing need for more data in people of color,4 given that over the course of about 20 years, the majority of Phase 3 PsO clinical trials (across topical, oral, and biologic therapies) have enrolled predominantly white participants (86 percent).5 The VISIBLE study is guided by the company’s strong commitment to bioethicsa and designed to help promote more diverse, equitable and inclusive clinical research in PsO through new approaches to enrollment and retention, broader community engagement and new data components.

“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, M.D., M.P.H., professor of clinical dermatology and vice-chair for diversity and inclusion at Weill Cornell Medicine in New York and lead study investigator.b “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 PsO and its symptoms when overactive in the body.6 For more than 20 years, biologics have been increasingly used to treat patients with autoimmune diseases, and these medications have been particularly effective in helping patients living with more severe forms of disease.

In line with its commitment to expanding inclusive clinical research, 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 PsO presents differently in people of color,7,8 the company is also offering training support for study investigators and taking a unique approach to confirm diagnosis.

About Psoriasis (PsO)
PsO is an immune-mediated disease resulting in an overproduction of skin cells, which causes raised, red, scaly plaques that may be itchy or painful.9 It is estimated that more than 8 million Americans and more than 125 million people worldwide live with the disease.3 Nearly one-quarter of all people with PsO have cases that are considered moderate to severe.3 Living with PsO can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life.2 Data on the clinical presentation of PsO amongst people of color are scarce, and there have been no large-scale prospective studies to date that evaluate the use of biologics exclusively in patients from diverse racial and ethnic backgrounds.2 People of color often are misdiagnosed or experience a delay in diagnosis, and they are less likely to receive treatment with more advanced and effective therapies, which can have negative effects on their physical health and quality of life.7,10

About TREMFYA® (guselkumab)
Developed by Janssen, TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque PsO and active psoriatic arthritis (PsA).11 TREMFYA is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque PsO who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA. It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

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