pharmaceufical-technologyNovember 27, 2017
Tag: Janssen , Tremfya , psoriasis
Janssen has announced the availability of Tremfya (guselkumab) in the UK for adults with moderate-to-severe plaque psoriasis.
Psoriasis, which affects up to 3% of the country’s population, can cause physical and psychological burdens.
Guselkumab is an injectable treatment for psoriasis and selectively targets interleukin (IL)-23, a key protein that initiates a specific immune inflammatory response.
Janssen UK medical director Dr Frank Wiegand 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."
"The availability of guselkumab in the UK provides an innovative new option to help address the continued needs of people living with plaque psoriasis."
The marketing authorisation and subsequent launch of guselkumab in the UK are based on data from three Phase III clinical studies.
The VOYAGE 1 and 2 trials compared guselkumab with placebo and HUMIRA (adalimumab).
The results 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 those receiving adalimumab, respectively.
No clear signals of increased risk of malignancy, major cardiovascular events or serious infections were reported during the clinical development programme for guselkumab in psoriasis.
Nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain were some of the adverse events reported in at least 5% of guselkumab-treated patients during the first 16 weeks in the trials.
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