Phase III VOYAGE 1 study of Tremfya shows efficacy in plaque psoriasis.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new long-term data from the open-label period of the Phase III VOYAGE 1 clinical trial. These data showed that 82 percent of patients receiving Tremfya (guselkumab) in the combined group of patients initially randomized to Tremfya or to placebo with crossover to Tremfya at week 16 achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) response and an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 204 (4 years). Tremfya is the first monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor to have been approved by the FDA.

Additional results from the open-label extension of the VOYAGE 1 Phase III clinical study showed that PASI 100, IGA 0/1, and IGA 0 clear skin responses were consistent at week 52 and week 204 in the combined group of patients initially randomized to Tremfya or to placebo with crossover to Tremfya at week 16. Proportions of patients with Psoriasis Symptoms and Signs Diary (PSSD) symptom scores of 0 (no symptoms of psoriasis) were consistent at week 76 and week 204. No new safety signals were identified. The data are being presented at the 39th Fall Clinical Dermatology Conference.