Guselkumab Clears Skin in Psoriasis Resistant to Topicals

Today, Johnson & Johnson unveiled groundbreaking results from the phase 3b SPECTREM trial (NCT06039189) in guselkumab (Tremfya) at the 2024 Fall Clinical Dermatology Conference.¹

New phase 3b data reveal significant skin clearance in historically underserved patients with moderate plaque psoriasis, offering hope for improved treatment outcomes. | Image credit: luchschenF - stock.adobe.com

"People who have special site plaque psoriasis with lesions that cover a smaller total area of their body are often only prescribed topical treatments and not considered candidates for advanced therapies, as treatment decisions are often driven by body surface area coverage and not symptomatic burden," said Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health, and study investigator, in a statement. "Results of the SPECTREM study could represent a new approach to care for patients with low body surface area psoriasis, as the majority of patients treated with Tremfya achieved clear or almost clear skin."

The study, focusing on adults with moderate plaque psoriasis and special site involvement, who had previously failed topical treatments, found that guselkumab achieved clear or almost clear skin in 74.2% of patients compared with 12.4% on placebo. This patient population has often been overlooked due to outdated clinical guidelines, but the trial highlights the potential for biologic therapies to transform care.

Earlier this year at the Maui Derm Hawaii 2024 Conference, Johnson & Johnson presented topline data from the phase 3b VISIBLE study (NCT05272150), showing that guselkumab demonstrated rapid and significant clearance in patients of color with moderate to severe scalp psoriasis and significant improvement in scalp itch, as well as patient-reported health-related quality of life outcomes.²

“Scalp psoriasis is highly prevalent and can present unique challenges across diverse populations,” said lead investigator, Andrew Alexis, MD, MPH, professor of clinical dermatology and vice chair for diversity and inclusion at Weill Cornell Medicine, in a statement. “In patients of color, cultural factors related to hair care practices and post-inflammatory pigment changes contribute to the burden of scalp psoriasis. These findings from VISIBLE are key to broadening our understanding of scalp psoriasis, and the role Tremfya can have in treating all patients with this disease.”

By week 16, significantly higher site-specific Investigator’s Global Assessment responses (score of 0/1) were observed with guselkumab compared with placebo: scalp (75.0% vs 14.5%), face (87.8% vs 28.6%), intertriginous (86.5% vs 28.8%), and genital (78.0% vs 37.5%), with all differences reaching statistical significance (P < .001).¹ Complete clearance was also consistently higher with guselkumab across these sites, with significant clearance rates seen for the scalp (60.3% vs 9.3%) and face (75.7% vs 23.9%).

Improvements extended across secondary measures, with 52.9% achieving Psoriasis Area Severity Index (PASI) 90, and average improvements exceeding 80% in body surface area and PASI. Patients treated with guselkumab also reported significant quality of life improvements, with 48.9% achieving Dermatology Life Quality Index scores of 0/1, and 62.7% noting a 4-point improvement in Psoriasis Symptoms and Signs Diary itch scores, highlighting its impact on both clinical and quality of life outcomes.

"The results from this study are aligned with our commitment to elevate the standard of care for the millions of adults impacted by moderate to severe plaque psoriasis, many of whom are currently overlooked and undertreated," said Brandee Pappalardo, PhD, MPH, vice president of dermatology and rheumatology medical affairs, Immunology, Johnson & Johnson Innovative Medicine, in a statement. "The positive SPECTREM data and Tremfya Clearance Photo Library both reinforce the significance of Tremfya as the only biologic treatment to demonstrate robust and clinically significant data across a broad range of patients, including those with low body surface area or special site plaque psoriasis, as well as patients of color."

References

1. New SPECTREM study findings reveal Tremfya (guselkumab) effectively clears overlooked and undertreated plaque psoriasis. Johnson & Johnson. News release. October 25, 2024. https://www.jnj.com/media-center/press-releases/new-spectrem-study-findings-reveal-tremfya-guselkumab-effectively-clears-overlooked-and-undertreated-plaque-psoriasis

2. Tremfya (guselkumab) demonstrates significant and rapid scalp psoriasis clearance in people of color in new large phase 3b study. Johnson & Johnson. News release. January 22, 2024. Accessed October 25, 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-demonstrates-significant-and-rapid-scalp-psoriasis-clearance-in-people-of-color-in-new-large-phase-3b-study