The first biologic to win approval to treat moderate to severe psoriasis was Astellas’ now-discontinued Amevive (alefacept) in 2003, paving the way for significant progress in the disease space. But despite the decades of research in psoriasis, some patients haven't been meaningfully represented in trials.
Johnson & Johnson’s VISIBLE study sought to address that disparity and was the first large psoriasis study to test a drug only in people of color. In the phase 3b, placebo-controlled trial, the company evaluated its psoriasis medicine Tremfya in patients who identified as nonwhite with moderate to severe plaque psoriasis or scalp psoriasis.
With the results, J&J can tout its drug as safe and effective across all skin tones. In the study, 57% of participants with plaque psoriasis reached skin clearance of at least 90% by Week 16, meeting one of the study's co-primary endpoints. Meanwhile, 71.9% of those with scalp psoriasis saw complete skin clearance at the same time point.
The study remains ongoing to collect more data.
It’s no secret that clinical research often misses the mark on diversity. In psoriasis specifically, a lack of medical knowledge about how the disease presents across different skin tones often leads to missed or incorrect diagnoses, according to J&J.
To make matters worse, the condition is often more detrimental to Black, Asian and Hispanic patients. Among them, 72% report that the disease affects quality of life, according to a numbers provided by J&J. That compares with 54% for white patients.
Still, people of color are 69% less likely to be prescribed biologic treatments, the company said.
One can “only imagine what that would do” to patients in terms of both treatment outcomes and psychological impacts, Janssen Dermatology’s head of medical affairs, Daphne Chan, Ph.D., said in an interview earlier this year.
There are several historic factors that make diverse enrollment in clinical trials a hurdle, including medical hesitancies and a lack of formal diagnoses.
To address these, J&J took a “holistic, community-driven” approach to planning the study, the company said. For example, J&J selected sites and investigators from diverse communities and built a racially and ethnically diverse steering committee.
The efforts resulted in full trial enrollment much faster than originally anticipated, the company said.
Meanwhile, J&J is also building a library of clinical images depicting the disease across skin tones. As it stands, fewer than 20% of images in dermatology textbooks demonstrate the condition in darker skin tones.
While the company was the first to run such a trial in psoriasis, it doesn’t want to be the only one to do so.
Beyond demonstrating the safety and efficacy of Tremfya, the larger mission for the study is to “set an example” of how to conduct inclusive research, Chan said.