Topline results from the phase 3b trial revealed significant improvements in patients with skin of color whose psoriasis was treated with guselkumab.
Janssen Pharmaceuticals, Inc., has announced1 significant findings from the phase 3b VISIBLE trial, a pioneering study dedicated to patients with skin of color. The study sought to objectively measure clearance and other treatment outcomes with guselkumab (TREMFAYA).
The VISIBLE trial's week 16 topline results, to be unveiled today at the 2023 Fall Clinical Dermatology Conference in Las Vegas, have demonstrated an exceptional level of skin clearance and rapid scalp psoriasis improvement while enhancing health-related quality of life for people with skin of color.
Mona Shahriari, MD, Central Connecticut Dermatology and VISIBLE Steering Committee member, stressed the significance of a study of this nature.
"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,” Shahriari said.1
At week 16, 74% of patients treated with guselkumab achieved an Investigator's Global Assessment score of cleared (0) or minimal disease (1). Additionally, 57.1% of patients witnessed at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) response, representing near complete skin clearance. Both measures surpassed those of patients who were treated with a placebo.
Scalp psoriasis saw equally significant improvements. As early as week 4, after only one dose of guselkumab, patients experienced a 53.8% mean improvement from baseline in the Psoriasis Scalp Severity Index. By week 16, 71.9% of patients achieved complete scalp clearance, while only 10% of patients in the placebo achieved the same improvement.
The impact of plaque psoriasis and its associated skin discoloration on HRQoL was a key aspect of the VISIBLE trial. At baseline, participants reported a significant impact of disease signs and symptoms on HRQoL. Post-inflammatory pigmentation was shown to be a significant factor affecting quality of life. Guselkumab outperformed the placebo in improving HRQoL, as evidenced by measures such as the Psoriasis Symptoms and Signs Diary, Dermatology Life Quality Index, and Skin Discoloration Impact Evaluation Questionnaire.
VISIBLE is not only generating clinical data but also an expansive library of clinical images capturing the disease's presentation across all skin tones. This effort responds to the stark underrepresentation of darker skin tones in dermatology textbooks and aims to bridge the gap in medical education, enabling clinicians to recognize clinical presentations in diverse populations.
Jennifer Davidson, vice president of medical affairs at Janssen Scientific Affairs, said,1 "As a medical community, partnering alongside community-driven clinicians and researchers is critical to create new research standards where diversity is both expected and necessary to represent the communities we all serve."