EU approves Tremfya for plaque psoriasis

Guselkumab is the first biologic that selectively blocks interleukin (IL)-23, a key driver of the immune inflammatory response in psoriasis.Guselkumab is a self-injectable (following training) treatment for psoriasis. Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks (q8w) thereafter.

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.

The NAVIGATE trial evaluated patients who did not achieve a response of cleared or minimal disease (Investigator's Global Assessment [IGA] 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). Adverse events reported in at least 5% of guselkumab-treated patients during the first 16 weeks in the VOYAGE 1 and 2 trials included: nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain.