Topline results from week 16 of a phase 3b trial demonstrated the efficacy and safety of Tremfya across all skin tones.
Tremfya (guselkumab) can clear plaque psoriasis and scalp psoriasis in patients across skin tones, according to topline data from a phase 3b trial. In the study, Tremfya demonstrated significant skin clearance, rapid scalp psoriasis clearance and improvement in health-related quality of life outcomes.
Developed by Janssen Pharmaceuticals, Tremfya is the first approved fully human monoclonal antibody that inhibits IL-23, which is an important driver of inflammation in moderate-to-severe plaque psoriasis and active psoriatic arthritis.
In a press release, Janssen reported week 16 results from Cohort A of the VISIBLE trial, the first prospective, large-scale trial dedicated to patients across all skin tones in patients with plaque psoriasis and scalp psoriasis. The study enrolled 211 patients and was designed to evaluate the efficacy and safety of Tremfya in patients who self-identified as non-White. The study consisted of two cohorts. Cohort A included patients with moderate-to-severe plaque psoriasis and Cohort B included patients with moderate-to-severe scalp psoriasis. Investigators also collected clinical photographs, colorimetry measures, clinician reported outcomes and patient reported outcomes.
“VISIBLE reinforces that to overcome the barriers of underrepresentation, undertreatment, and lack of access to care that many people of color with plaque psoriasis face, additional data about the disease journey are needed to improve treatment outcomes and quality of life for people with skin of color,” Mona Shahriari, M.D., Central Connecticut Dermatology and VISIBLE Steering Committee member, said in the press release.
After only three doses, patients taking Tremfya saw significantly greater improvements in disease signs and symptoms and significantly greater improvements in body surface area. At week 16, about one-third of patient achieved complete skin clearance base on the Psoriasis Area Severity Index (PASI 90).
As early as week 4, after only one dose of Tremfya, patients saw improvement from baseline on the Psoriasis Scalp Severity Index, and 26.3% of participants achieved complete scalp clearance at week 4. At week 16, 71.9% of patients achieved complete scalp clearance.
The VISIBLE study is ongoing with an active treatment period from week 16 to week 48 and a long-term extension through week 112.