TREMFYA (Guselkumab) Improves PsO Symptoms Across All Skin Tones

The VISIBLE study is the first-of-its-kind, fully inclusive study in plaque PsO research history to exclusively study people of color across skin tones.

TREMFYA demonstrated significant skin clearance, rapid scalp psoriasis clearance and improvement in health-related quality of life outcomes in psoriasis patients across all skin tones, according to results from Cohort A of the VISIBLE trial. 

This study, which was presented at the 2023 Fall Clinical Dermatology Conference in Las Vegas, included patients with all skin tones who had moderate to severe plaque psoriasis and scalp psoriasis.

In this previously understudied population, no new safety signals were reported through Week 16. 

“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 in people with skin of color,” says Mona Shahriari, MD, Central Connecticut Dermatology and VISIBLE Steering Committee member, in a news release. “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 a diverse psoriasis patient population.”

At a Glance: Guselkumab Skin Clearance Data at Week 16

• At Week 16, 74% of patients receiving TREMFYA achieved an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) and 57.1% achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) response (near complete skin clearance), successfully meeting the study’s co-primary endpoints versus placebo (0% and 3.8%, respectively).
• After only three doses, significantly greater improvements in disease signs and symptoms (e.g., change from baseline in PASI scores) were observed in patients receiving TREMFYA (84.5%) versus placebo (8.3%). Significantly greater improvements in body surface area (BSA) involvement were observed in patients receiving TREMFYA (77.9%) versus placebo (0.9%).
• Approximately one-third of patients receiving TREMFYA achieved complete skin clearance (IGA 0 and PASI 100 versus placebo (0%) at week 16.

Guselkumab Rapid and Significant Scalp Psoriasis Clearance Data at Week 16

• As early as Week 4, after only one dose of TREMFYA, the mean percentage improvement from baseline Psoriasis Scalp Severity Index (PSSI) was 53.8% in patients treated with TREMFYA versus placebo (12.3%).
• After one dose of TREMFYA, 26.3% of participants achieved complete scalp clearance (ss-IGA 0) versus placebo (0%) at Week 4.
• At Week 16, 71.9% of patients receiving TREMFYA achieved complete scalp clearance versus placebo (10%).

Guselkumab Health-Related Quality (HRQoL) of Life and Post- Inflammatory Pigmentation Data

• At baseline, VISIBLE participants reported disease signs and symptoms have significant impact on HRQoL. They also reported moderate effect of skin discoloration on HRQOL. Post-inflammatory pigmentation is part of the natural history of psoriasis and is known to be a key factor impacting quality of life.
• VISIBLE was prospectively designed to also collect clinical photographs, colorimetry measures, clinician reported outcomes and patient reported outcomes.
• At Week 16, improvements in the Psoriasis Symptoms and Signs Diary (PSSD), Dermatology Life Quality Index (DLQI) and Skin Discoloration Impact Evaluation Questionnaire (SDIEQ) were significantly greater in patients receiving TREMFYA versus placebo across all skin tones.

VISIBLE will continue to expand understanding of plaque PsO by aiming to generate an expansive, longitudinal library of thousands of clinical images capturing the disease’s presentation across all skin tones. Only 4-19% of images in dermatology textbooks showcase conditions in darker skin tones, illustrating the opportunity for VISIBLE to contribute to medical education to help clinicians recognize clinical presentation across all skin tones and patients better understand their diagnosis with images of other patients who look like them.

The study used a holistic, community-driven approach that leads with intentional site and investigator selection from diverse communities, involvement of a racially and ethnically diverse steering committee of dermatologists involved in protocol development and study execution, community engagement and awareness building, as well as educational and cultural training support for clinical investigators. Colorimetry was utilized as an objective method to determine baseline skin tone and track progress of psoriatic lesions to help minimize potential investigator subjectivity and bias.

“The VISIBLE study is a direct representation of where scientific innovation meets inclusivity as it will continue to generate new data and imagery to help create a world where people of color living with plaque psoriasis, and their providers, can have more informed discussions about treatment options,” says Jennifer Davidson, DO, Vice President, Medical Affairs, Immunology, Janssen Scientific Affairs, LLC. “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. Our aim is for VISIBLE to help transform research processes, which will help to increase treatment options for so many more patients.”

The VISIBLE Study

VISIBLE (n=211) is a phase 3b, multicenter, randomized, double-blind, placebo- controlled (Weeks 0-16) trial in adult patients (≥18 years of age) with moderate to severe body and/or scalp psoriasis. Patients were randomized to TREMFYA® 100 mg subcutaneous injection at Weeks 0, 4, and 12, then q8w; placebo at Weeks 0, 4, and 12, followed by crossover to TREMFYA at Week 16, Week 20, and q8w. The study was designed to evaluate the efficacy and safety of TREMFYA in skin of color patients (self-identify as non-white) across the entire spectrum of the Fitzpatrick scale (I-VI). The study consisted of 2 cohorts, Cohort A: moderate to severe plaque psoriasis (IGA ≥3, PASI ≥12, and body surface area involvement of ≥10%) and Cohort B: moderate to severe scalp psoriasis (SSA ≥30%, PSSI ≥12, ss-IGA ≥3, and ≥1 plaque outside the scalp) for at least 6 months before study administration, or central photo review expert confirmed psoriasis diagnosis, or biopsy confirmed psoriasis. The VISIBLE study is still ongoing with an active treatment period from Weeks 16-48 and long-term extension through Week 112 where patients continued receiving TREMFYA q8w.

The study will evaluate approximately 211 participants from the U.S. and Canada who will be treated and followed for approximately two years.