The study aims to generate data related to Tremfya in people of color who have plaque psoriasis.
Janssen Pharmaceutical Companies of Johnson & Johnson has initiated a large-scale prospective trial to study Tremfya (guselkumab) in people of color living with moderate-to-severe plaque psoriasis.
Called VISIBLE, the trial is a randomized phase 3b multicenter, placebo-controlled study examining the efficacy and safety of Tremfya administered by subcutaneous injection in participants with moderate-to-severe plaque psoriasis and/or moderate to severe scalp psoriasis who self-identify as non-white. The study will recruit about 200 participants from the United States and Canada who will be treated and followed for two years.
“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,” Andrew Alexis, M.D., professor of clinical dermatology and vice-chair for diversity and inclusion at Weill Cornell Medicine in New York and lead study investigator of the study said in a press release.
Tremfya is 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 psoriasis and active psoriatic arthritis.
It is approved in the United States, Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate-to-severe plaque psoriasis.
Psoriasis is an immune-mediated disease that causes raised, red, scaly plaques that may be itchy or painful. It is estimated that more than 8 million Americans and more than 125 million people worldwide live with the disease.
Data on psoriasis among people of color are scarce. One study from 2014 found that psoriasis is affect about 1.9% African Americans and 1.6% of Hispanic populations. A more recent study found that racial/ethnic minority patients may be under treated, especially with biologics that treat more severe disease. In this study, investigators found that minorities are not familiar with biologics, prefer to avoid needles, and fear side effects. Additionally, people of color are less likely to see a dermatologist about their psoriasis.