The VISIBLE study, investigating the efficacy of guselkumab (Tremfya) in patients with skin of color suffering from moderate to severe plaque and scalp psoriasis, has yielded promising 48-week results. The findings, presented at the 2024 Skin of Color Update, indicate significant skin clearance, with over 70% of participants achieving clear or minimal disease and more than half reaching complete clearance.
Rapid Enrollment and High Retention
Notably, the VISIBLE study enrolled participants seven times faster than anticipated and maintained a retention rate exceeding 90%. According to Amy McMichael, MD, a professor of dermatology at Wake Forest University and a member of the VISIBLE Steering Committee, this success stemmed from Janssen's proactive engagement with leaders in the field and a commitment to training new investigators. The study also addressed logistical barriers by providing car services, at-home dosing, and translated materials in eight languages.
Clinical Significance of Guselkumab
Dr. McMichael emphasized the clinical significance of these findings, stating, "This trial has allowed us to actually say: This drug works for psoriasis, both scalp and body, in patients with skin of color." She highlighted that psoriasis in individuals who self-identify as Black or African American tends to be more hypertrophic and harder to treat. The VISIBLE study demonstrated that guselkumab was effective across all skin types, challenging previous assumptions about treatment efficacy in diverse populations.
Addressing Post-Inflammatory Pigmentation
A key concern in treating psoriasis in patients with skin of color is post-inflammatory pigmentation. The VISIBLE study addressed this by creating an extensive photographic library documenting the effects of treatment on pigmentation over time. This resource will be invaluable for understanding and managing post-inflammatory hyperpigmentation in diverse skin types.
The Need for Inclusive Clinical Trials
Dr. McMichael stressed the importance of including patients with skin of color in future clinical trials. She urged dermatologists, patients, and other stakeholders to demand greater representation in research. "If investigators demand that patients of color are included, and that they're given the things, the tools, that they need to actually recruit these patients before they start the trial, it's going to happen. But we all have to band together to do that," she stated.
Implications for Clinical Practice
For clinicians not directly involved in clinical trials, Dr. McMichael recommends increasing their knowledge base by paying attention to studies like VISIBLE. She aims to dispel the misconception that biologics are not effective in patients with skin of color, emphasizing that "these drugs can work. We just have to get them in the trials to show that people with skin of color do actually respond."
