Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, announced new Phase 3b topline Week 16 results from Cohort A of the VISIBLE trial, the first prospective, large-scale, randomized-controlled trial dedicated to patients across all skin tones with moderate to severe plaque psoriasis and scalp psoriasis to objectively measure clearance and other treatment outcomes with TREMFYA® (guselkumab). In the study, TREMFYA demonstrated significant skin clearance, rapid scalp psoriasis clearance, and improved health-related quality of life outcomes. In this previously understudied population, no new safety signals were reported through Week 16.1,2,3.
“VISIBLE reinforces that to overcome the barriers of underrepresentation, undertreatment, and lack of access to care that many people of color with plaque psoriasis face, additional data about the disease journey are needed to improve treatment outcomes and quality of life for people with skin of color,” said Mona Shahriari, M.D., Central Connecticut Dermatology and VISIBLE Steering Committee member.
“In addition to insightful data, VISIBLE has provided the medical community with key learnings around study design and representative clinical imagery that have the potential to tangibly address the unmet needs of the diverse psoriasis patient population.”
A first-of-its-kind study 100% dedicated to people of color living with moderate to severe plaque psoriasis (PsO) is redefining representation in clinical research and helping to bridge critical gaps in care. People of color with plaque PsO face challenges like misdiagnosis, delayed diagnosis, and advanced treatment access barriers at much higher rates, in part because they have been severely underrepresented in clinical research. This has created significant health disparities, especially within the dermatology field, where people of color have accounted for as low as 5% of participants in some PsO clinical studies.
Additionally, only 4-19% of images in dermatology textbooks show conditions on darker skin tones. This lack of representation has created barriers that have caused people of color to face delayed diagnoses, misdiagnoses, and limited access to advanced treatments. To address these challenges, Janssen is working alongside community-driven researchers on the VISIBLE study to highlight plaque PsO research history to study people of color across skin tones exclusively.
- The study demonstrated TREMFYA’s (guselkumab) well-established efficacy and safety profile across all skin tones.
- 74% of patients achieved cleared or minimal disease, and 57% achieved at least a 90% improvement (near complete skin clearance) at Week 16.
- At Week 16, 71.9% of patients achieved complete clearance in their scalp PsO.
- Patient-reported outcomes from the study showed improvement in itch, overall symptoms, post-inflammatory pigmentation, and quality of life.
- VISIBLE employed innovative strategies to remove barriers to clinical research that people of color often face, which can be broadly applied across the healthcare industry to create a more equitable research process and improve access to care for patients.
This study enrolled seven times faster than expected and is working to address these barriers by generating new insights around the psoriatic disease journey in people of color, as well as employing innovative strategies that can be implemented throughout the medical community to create a more equitable research process overall. In addition, the study is creating an expansive library of images showing PsO across skin tones that will help patients and physicians recognize the disease on the skin of color.