Janssen announces Phase 3b Week 16 results from Cohort A of VISIBLE trial

Janssen Pharmaceuticals, a Johnson & Johnson company, announced new Phase 3b topline Week 16 results from Cohort A of the VISIBLE trial. These data will be presented today at the 2023 Fall Clinical Dermatology Conference in Las Vegas, Nevada. Guselkumab Skin Clearance Data at Week 16 Poster: At Week 16, 74% of patients receiving TREMFYA achieved an Investigator’s Global Assessment score of cleared or minimal disease and 57.1% achieved at least a 90% improvement in the Psoriasis Area Severity Index response, successfully meeting the study’s co-primary endpoints versus placebo. After only three doses, significantly greater improvements in disease signs and symptoms were observed in patients receiving TREMFYA versus placebo. Significantly greater improvements in body surface area involvement were observed in patients receiving TREMFYA versus placebo. Approximately one-third of patients receiving TREMFYA achieved complete skin clearance PASI 100, IGA 0 versus none for placebo at week 16. Guselkumab Rapid and Significant Scalp Psoriasis Clearance Data at Week 16 Poster: As early as Week 4, after only one dose of TREMFYA, the mean percentage improvement from baseline Psoriasis Scalp Severity Index was 53.8% in patients treated with TREMFYA versus 12.3% for placebo. After one dose of TREMFYA, 26.3% of participants achieved complete scalp clearance versus none for placebo at Week 4. At Week 16, 71.9% of patients receiving TREMFYA achieved complete scalp clearance versus 10% for placebo. Guselkumab Health-Related Quality of Life and Post-Inflammatory Pigmentation Data Poster: At baseline, VISIBLE participants reported disease signs and symptoms have significant impact on HRQoL. They also reported moderate effect of skin discoloration on HRQOL. At Week 16, improvements in the Psoriasis Symptoms and Signs Diary, Dermatology Life Quality Index and Skin Discoloration Impact Evaluation Questionnaire were significantly greater in patients receiving TREMFYA versus placebo across all skin tones.