Guselkumab Demonstrates Significant Improvements in People of Color With Scalp Psoriasis

Guselkumab (Tremfya) showed rapid and significant clearance in patients of color with moderate-to-severe scalp psoriasis, as well as significant improvement in scalp itch and patient-reported health-related quality-of-life outcomes, including post-inflammatory pigmentation at 16 weeks.

Woman with scalp itch | Small fish - stock.adobe.com

This first-of-its-kind phase 3b study adds to growing evidence that guselkumab is effective for adults with moderate to severe plaque psoriasis across all skin tones.

These topline data findings were presented today at the Maui Derm Hawaii 2024 conference.

"It is believed that scalp psoriasis is more common and more severe in people of color, especially among Asian and Black patients," Andrew Alexis, MD, MPH, professor of Clinical Dermatology and vice chair for diversity and inclusion at Weill Cornell Medicine and lead study investigator, said in a statement. “These findings from VISIBLE are key to broadening our understanding of scalp psoriasis, and the important role Tremfya can have in effectively treating all patients with this disease.”

Scalp psoriasis is known to cause great physical and social distress, with up to 97% of affected individuals reporting that their condition interferes with their daily life. Additionally, scalp psoriasis is often associated with intense pruritis and scaling and can even result in alopecia.

In VISIBLE Cohort B, the researchers identified 108 individuals with moderate to severe psoriasis, with the aim of measuring clearance and treatment outcomes with guselkumab compared with placebo.

The researchers included measures based on Psoriasis Scalp Severity Index (PSSI), Scalp Surface Area (SSA), and scalp-specific Investigator's Global Assessment (ss-IGA).

At Week 16, patients experienced nearly 90% improvement from baseline after 3 doses of guselkumab, compared with placebo (PSSI 100, 65.8% vs 3.8%; SSA, 86.6% vs 33.4%). Complete scalp clearance was achieved in most patients receiving guselkumab compared with placebo (PSSI 100, 59.2% vs 3.8%; ss-IGA 0, 57.9% vs 3.8%). No new safety signals were reported in this previously understudied patient population throughout the study period.

Additionally, nearly 7 in 10 patients receiving guselkumab achieved a clinically meaningful improvement on the Scalp Itch Numeric Rating Scale compared with placebo (69.4% vs 24%). Significantly greater improvements were reported in the Psoriasis Symptoms and Signs Diary and Dermatology Life Quality Index by patients across all skin tones compared with placebo.

Furthermore, the researchers assessed post-inflammatory pigment alteration (PIPA) using Skin Discoloration Impact Evaluation Questionnaire scores. At baseline, patients were experiencing at least moderate or greater impact of skin discoloration on their health-related quality of life. At Week 16, patients who received guselkumab reported mild improvements on their health-related quality of life from skin discoloration. However, guselkumab is not indented to treat PIPA.

"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, said Jennifer Davidson, DO, vice president of medical affairs, immunology, Johnson & Johnson Innovative Medicine, in a following statement. “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."

Reference

Tremfya (guselkumab) demonstrates significant and rapid scalp psoriasis clearance in people of color in new large phase 3b study. Johnson & Johnson. New release. January 22, 2024. Accessed January 19, 2024.