The journey to improved treatments for psoriasis, a challenging skin condition, has been long and complex. Despite advances, some patient groups have remained underrepresented in clinical trials. Johnson & Johnson recognized this disparity and embarked on a groundbreaking endeavor, the VISIBLE study, which stands as the first major psoriasis trial exclusively focused on individuals of color. In this pivotal phase 3b trial, Johnson & Johnson evaluated the effectiveness of its psoriasis medication, Tremfya, in patients who self-identified as nonwhite, dealing with moderate to severe plaque psoriasis or scalp psoriasis.
The results of the VISIBLE study are indeed noteworthy. They showcase Tremfya as a safe and effective treatment for patients of all skin tones. Among participants with plaque psoriasis, 57% achieved a remarkable skin clearance of at least 90% by Week 16, satisfying one of the study’s primary objectives. In parallel, a remarkable 71.9% of those with scalp psoriasis experienced complete skin clearance within the same time frame. It’s important to note that the study is still ongoing to amass more valuable data.
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Clinical research has often fallen short in ensuring diversity in its study populations. In the realm of psoriasis, this gap has been compounded by a limited understanding of how the disease manifests across various skin tones, leading to inaccurate diagnoses or missed cases. Johnson & Johnson highlighted that the impact of psoriasis tends to be more severe among Black, Asian, and Hispanic patients. In fact, a striking 72% of these patients report a negative impact on their quality of life, as opposed to 54% of their white counterparts.
Compounding the issue is the fact that individuals of color are 69% less likely to be prescribed biologic treatments. The consequences of such disparities are significant, influencing treatment outcomes and taking a toll on the psychological well-being of these patients.
Historical factors have contributed to the challenge of achieving diverse enrollment in clinical trials, including medical mistrust and a lack of formal diagnoses.
Johnson & Johnson tackled these issues with a “holistic, community-driven” approach to design the VISIBLE study. The company selected research sites and investigators from diverse communities and established a steering committee that embraced racial and ethnic diversity. These efforts paid off, as full trial enrollment occurred more rapidly than anticipated.
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Furthermore, Johnson & Johnson is actively working to create a library of clinical images that accurately represent the disease across different skin tones. Currently, fewer than 20% of images in dermatology textbooks depict the condition in individuals with darker skin tones.
While Johnson & Johnson was the pioneering force behind such a groundbreaking trial in psoriasis, it aims to inspire others to follow suit. Beyond proving Tremfya’s safety and efficacy, the broader mission of the VISIBLE study is to set a precedent for conducting inclusive and diverse research. In doing so, it aspires to open new doors for equitable access to cutting-edge treatments in the field of dermatology and beyond.
