News

Janssen's psoriasis jab launched in UK

Amy Schofield 24 November 2017

Janssen's Tremfya® (guselkumab) is now available in the UK for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Guselkumab is the first biologic to selectively target interleukin (IL)-23, a key protein that initiates a specific immune inflammatory response.

Guselkumab is an injectable treatment for psoriasis and can be self-administered following training. Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks (q8w) thereafter.

Psoriasis affects up to 3% of the UK population, an estimated 1.8 million people. It can cause great physical and psychological burden with approximately one third of people with psoriasis experiencing depression and anxiety.

The marketing authorisation and subsequent UK launch are based on data from three Phase 3 clinical studies.

The VOYAGE 1 and 2 trials, which compared guselkumab with placebo and HUMIRA® (adalimumab), showed high levels of skin clearance after 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 [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 had a significantly higher mean number of visits with patients achieving 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).

During the clinical development programme for guselkumab in psoriasis there were no clear signals of increased risk of malignancy, major cardiovascular events or serious infections, including tuberculosis and re-activation of latent tuberculosis.

Dr Frank Wiegand, Medical Director, Janssen UK, said: “At Janssen, we are committed to bringing innovative new therapies that help to improve the lives of those living with these debilitating diseases. The availability of guselkumab in the UK provides an innovative new option to help address the continued needs of people living with plaque psoriasis.”

 

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