New Phase 3b Findings Show Guselkumab Leads to Significant Skin Clearance for Psoriasis

Linda Stein Gold, MD

Credit: Henry Ford Health

On October 25, it was announced by Johnson & Johnson that treatment with guselkumab (Tremfya) led to clear or almost clear skin for the majority of adult patients who failed topical therapy and had low body surface area (BSA) moderate plaque psoriasis and special site involvement.¹

These new phase 3b findings from the SPECTREM study were presented at the 2024 Fall Clinical Dermatology Conference in Las Vegas. The research was authored by such investigators as Linda Stein Gold, MD, vice president of the American Academy of Dermatology and the head of the division of dermatology at the Henry Ford Health System.²

"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," Stein Gold said in a statement.¹

Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease which results in inflamed and scaly plaques and is known to impact approximately 125 million people globally.³ Areas of the body considered “special sites” include sensitive or highly visible regions affected by psoriasis, including patients’ face, scalp, skin folds and genital area.

Systemic treatment is infrequently provided to those with special site involvement and this group of psoriasis patients is known to be largely undertreated. Guselkumab, a biologic therapy option, was previously approved for adult patients with diagnoses of moderate to severe psoriasis who may require systemic treatment (oral or injectable therapies) or may require phototherapy.

The phase 3b SPECTREM trial had a prospective, randomized, double-blind, and placebo-controlled study design. It was notable given that it was the first large-scale clinical investigation evaluating skin clearance and treatment outcomes for individuals with low BSA moderate psoriasis specifically impacting difficult-to-treat regions.²

In SPECTREM, researchers evaluated guselkumab compared to a placebo for the treatment of moderate plaque psoriasis with low BSA and special site involvement. There were 338 subjects recruited for the study who were randomized approximately 2:1 to be treated with 100 mg subcutaneous guselkumab at the initiation and at the 4-week mark.

This was then followed by administration every 8 weeks. If not, they were given placebo at Weeks 0 and 4, and there was a crossover to guselkumab at the 16-week mark. Those assessed had psoriasis with 2-15% BSA and at least a single plaque outside their special sites, with moderate severity or higher in at least 1 special site as determined through an Investigator’s Global Assessment (IGA).

"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 (guselkumab) achieved clear or almost clear skin,” Stein Gold said in a statement.¹

The primary outcome of the analysis indicated that a significantly higher percentage of individuals in the guselkumab cohort reached an IGA score of “cleared” or “minimal” compared to those in the placebo cohort (74.2% versus 12.4%; P < .001). The investigators found that site-specific rates of disease clearance for those on guselkumab versus placebo had been notably higher as well.

They highlighted scalp results for the drug compared to placebo (75.0% versus 14.5%), intertriginous areas (86.5% versus 28.8%), face (87.8% versus 28.6%), and genital region (78.0% versus 37.5%) (P < .001).

The research team highlighted the fact that at each site, complete clearance was achieved in the majority of guselkumab-treated subjects, noting the rates specifically for face (75.7% versus 23.9%), intertriginous areas (76.6% versus 24.2%), scalp (60.3% versus 9.3%),and genitals (72.7% versus 32.7%).

References

1. ^{New SPECTREM study findings reveal TREMFYA® (guselkumab) effectively clears overlooked and undertreated plaque psoriasis. Johnson & Johnson. October 25, 2024. https://www.prnewswire.com/news-releases/new-spectrem-study-findings-reveal-tremfya-guselkumab-effectively-clears-overlooked-and-undertreated-plaque-psoriasis-302287251.html. Date accessed: October 25, 2024.}
2. ^{Stein Gold L, Strober B, Armstrong AW, et al. SPECTREM: Guselkumab Demonstrates Consistent Significant Clearance at Week 16 Across the Full Range of Low Body Surface Area, Moderate Psoriasis with Special Sites Involvement. Poster presented at: 2024 Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV.}
3. ^{National Psoriasis Foundation. Psoriasis statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed October 23, 2024.}