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Recently announced trial results demonstrate the efficacy of the biologic in multiple disease indications.
Recent clinical trial data regarding guselkumab (Tremfya; Johnson & Johnson) indicate the effectiveness of the biologic interleukin-23 (IL-23) inhibitor in clearing overlooked and undertreated plaque psoriasis, in addition to helping patients with Chron disease manage their symptoms and achieve clinical remission.1,3
Guselkumab has shown effectiveness in treating a variety of diseases and conditions. | Image Credit: © luchschenF | stock.adobe.com
The phase 3b SPECTREM trial (NCT06039189) is the first prospective, large-scale, randomized-controlled clinical trial to measure skin clearance and other treatment outcomes in adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment.1,2
“Special sites” are sensitive or highly visible areas affected PsO; these include the face, scalp, skin folds, and genitals. They often have a significant impact on the daily lives of patients; however, systematic treatment is often not provided, and these patients remain undertreated. This trial sought to evaluate the effects of guselkumab on these patients, specifically regarding the primary end point of an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) compared to placebo.1
Results indicated that a significantly greater proportion of patients who received guselkumab achieved the optimal IGA scores (74.2%), compared with placebo (12.4%). In each special site examined at week 16—scalp (75.0% versus 14.5%), face (87.8% versus 28.6%), intertriginous (86.5% versus 28.8%) and genital (78.0% versus 37.5%)—improvements were seen with guselkumab compared with placebo.1
Trial Name: Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis (SPECTREM)
ClinicalTrials.gov ID: NCT06039189
Sponsor: Janssen Research & Development, LLC
Estimated Completion Date: May 26, 2025
“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,” Linda Stein Gold, MD, SPECTREM investigator, said in the news release. “Results of the SPECTREM study could represent a new approach to care for patients with low body surface area psoriasis.”1
Guselkumab was also evaluated in the phase 3 GRAVITI study (NCT05197049). Investigators sought to evaluate the effects of subcutaneous induction and maintenance therapy with guselkumab in adults with moderately- to severely-active Crohn disease (CD). Results of this trial were presented at the American College of Gastroenterology 2024 meeting.3,4
Over half of patients treated with guselkumab 400 mg, administered subcutaneously at weeks 0, 4, and 8, achieved clinical remission (56.1%) compared with individuals receiving placebo (21.4%). In 41.3% of patients treated with guselkumab SC induction therapy, an endoscopic response was achieved, compared with 21.4% in the placebo group. Importantly, improvements in clinical remission were seen as early as week 4 in some patients, demonstrating the drug’s rapid onset of action.3
Trial Name: A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease (GRAVITI)
ClinicalTrials.gov ID: NCT05197049
Sponsor: Janssen Research & Development, LLC
Estimated Completion Date: March 31, 2025
Longer-term follow-up data at week 48 was also found. Clinical remission rate was more than 3 times higher with both maintenance doses of guselkumab versus placebo (60.0% for 100 mg SC every 8 weeks, 66.1% for 200 mg SC every 4 weeks, vs 17.1%). Again, a robust endoscopic response was observed, for patients receiving both 100 mg and 200 mg guselkumab.3
These trial results follow guselkumab’s regulatory approval by the FDA for the treatment of moderate-to-severe ulcerative colitis in September 2024, becoming the first and only approved fully human and dual-acting monoclonal antibody.5
Based on the positive results of SPECTREM and GRAVITI, guselkumab could receive consideration by the FDA for regulatory approval to treat other conditions, like Crohn disease and plaque psoriasis, soon.
