23 November 2017 - Janssen’s guselkumab is the first biologic to be approved that selectively blocks interleukin 23.

Janssen-Cilag announced today that the European Commission has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Guselkumab is the first biologic that selectively blocks interleukin 23, a key driver of the immune inflammatory response in psoriasis.

The EC approval is based on data from three Phase III clinical studies. The VOYAGE 1 and 2 trials, which compared guselkumab with placebo and Humira (adalimumab), showed high levels of skin clearance after just 16 weeks, with at least a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) in 73.3% and 70.0% of patients receiving guselkumab, compared with 49.7% and 46.8% in patients receiving adalimumab, respectively (P<0.001).

The NAVIGATE trial evaluated patients who did not achieve a response of cleared or minimal disease (Investigator's Global Assessment score of 0 or 1) by week 16 when treated with Stelara (ustekinumab), and were then randomised to either switch to guselkumab or continue on ustekinumab. The guselkumab group benefited significantly from the switch, with a significantly higher mean number of visits at which patients achieved an IGA score of 0 or 1 and at least a 2-grade improvement from week 28 through week 40 (relative to week 16), compared to the ustekinumab group (1.5 vs 0.7; P<0.001).

Read Janssen press release