Tremfya (guselkumab) demonstrates significant and rapid scalp psoriasis clearance in people of color in new large phase IIIb study

Topline data from Cohort B in the Phase IIIb VISIBLE study were presented today at the Maui Derm Hawaii 2024 conference.

VISIBLE is the first prospective, large-scale, randomized-controlled trial dedicated to people of color across all skin tones with moderate to severe plaque PsO and scalp PsO to objectively measure clearance and other treatment outcomes with Tremfya. The VISIBLE clinical program will produce an expansive longitudinal collection of more than 20,000 clinical images across all skin tones to support patients and providers with disease recognition and education. Cohort B of the study enrolled 108 people of color with scalp predominant moderate-to-severe PsO, a clinically proven difficult-to-treat area. Tremfya demonstrated significant and rapid scalp PsO clearance and improvement in scalp itch as well as patient-reported health-related quality of life (HRQoL) outcomes.

Guselkumab Significant and Rapid Scalp Clearance Data at Week 16 Poster: At Week 16, after three doses, patients receiving Tremfya achieved significantly greater improvements versus placebo: At Week 16, nearly 7 in 10 patients receiving TRemfya achieved the study’s co-primary endpoints, Scalp-Specific Investigator Global Assessment (ss-IGA) score of 0/1 (68.4% vs 11.5% placebo) and Psoriasis Scalp Severity Index (PSSI) 90 response (65.8% vs 3.8% placebo). Of note, ~90% of patients who met the study’s co-primary endpoints achieved complete scalp clearance (ss-IGA 0 or PSSI 100).Patients receiving Tremfya experienced nearly 90 percent improvement from baseline in PSSI (87.6% vs 37.8% placebo) and in Scalp Surface Area (SSA) (86.6% vs 33.4% placebo). In this previously understudied population, no new safety signals were reported through Week 16.

Guselkumab Patient-Reported Health-Related Quality of Life (HRQoL) Improvements Poster: Scalp PsO is often associated with bothersome symptoms such as intense pruritus and scaling. In some cases, it can even result in alopecia which, in most cases, is reversible with appropriate and timely treatment. At Week 16, nearly 7 in 10 patients receiving TREMFYA (69.4% vs 24% placebo) achieved a clinically meaningful improvement on the Scalp Itch Numeric Rating Scale (NRS). At Week 16, significantly greater improvements in the Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) were reported by patients receiving TREMFYA versus placebo across all skin tones.

Guselkumab Patient-Reported Post-Inflammatory Pigmentation Data Poster: i. Post-inflammatory pigment alteration (PIPA) refers to the skin discoloration that may occur after skin inflammation or injury, which is a part of the natural process of inflammatory diseases like psoriasis. PIPA can affect all skin tones and significantly impact quality of life, particularly for those with melanin-enriched skin types. ii. At baseline, mean score as assessed by the Skin Discoloration Impact Evaluation Questionnaire (SDIEQ) indicated patients were experiencing at least moderate impact of skin discoloration on their HRQoL. iii. At Week 16, patients treated with TREMFYA reported they have experienced improvements, with only a mild effect from skin discoloration on their HRQOL. TREMFYA is not intended to treat PIPA.

Cohort A of the VISIBLE study, announced in October 2023, focused on patients of color with skin predominant PsO and provided additional data on the safety and effectiveness of Tremfya across all skin tones. Coupled with the latest Cohort B findings, the collective data reinforces that the unique study design of VISIBLE is a successful model to enroll, retain and support people of color who have historically been undertreated and underrepresented in clinical trials, and an inclusive research process may create lasting impact on furthering medical education and patient education.

“Scalp psoriasis can be particularly burdensome to patients as it often impacts more visible areas of the body, including the hairline, forehead, neck, and around the ears, triggering feelings of self-consciousness that limit many people’s lifestyle choices,” said Jennifer Davidson, D.O., Vice President of Medical Affairs, Immunology, Johnson & Johnson Innovative Medicine. “The VISIBLE study suggests that people of color continue to experience undertreatment, with many participants not receiving a biologic option prior to this trial enrollment. The insights from the study aim to empower diverse patients with moderate to severe plaque and scalp psoriasis to learn more about their treatment options and initiate informed discussions with their providers.”

Tremfya is the first IL-23 inhibitor approved in the U.S. to treat both adults with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis (PsA).