Johnson & Johnson (J&J) has shared positive results from a late-stage study of its dual-acting IL-23 inhibitor Tremfya (guselkumab) in plaque psoriasis patients.
The phase 3b SPECTREM trial has been evaluating the drug in adults with low body surface area (BSA) moderate plaque psoriasis with special site involvement who had failed topical treatment.
Affecting more than 125 million people worldwide, plaque psoriasis is an immune-mediated disease characterised by inflamed, scaly plaques that may be itchy or painful.
Sensitive or highly visible areas affected by the condition, including the scalp, face and genitals, are considered ‘special sites’ and can have significant impact on patients’ daily lives. Despite this, these patients remain largely under-treated, J&J outlined.
Already holding approvals to treat certain cases of plaque psoriasis, active psoriatic arthritis and ulcerative colitis, Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and bind to the CD64 receptor.
Data presented at this year’s Fall Clinical Dermatology Conference showed that a significantly greater proportion of patients who received Tremfya in SPECTREM achieved the primary endpoint of an Investigator’s Global Assessment (IGA) score of zero or one (clear/almost clear skin) compared to those who received placebo, at 74.2% versus 12.4%.
In scalp, facial, intertriginous and genital areas, IGA scores of zero or one were achieved by 75%, 87.8%, 86.5% and 78% of Tremfya-treated patients, and complete clearance of each special site was consistently achieved in the majority of patients who received Tremfya versus placebo.
Statistically significant improvements were also achieved across all major secondary endpoints, with 52.9% of Tremfya-treated patients achieving a Psoriasis Area Severity Index of 90 compared to 6.2% of those who received placebo.
SPECTREM investigator, Linda Stein Gold, Henry Ford Health, said: “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.
“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.”