Janssen-Cilag's Stelara backed by UK's NICE for moderate-to-severe plaque psoriasis

Janssen-Cilag, a Johnson & Johnson company, says that its Stelara (ustekinumab) has today been approved by the UK's National Institute for Health and Clinical Excellence (NICE) as a treatment option under the National Health Service in England and Wales for adults with moderate-to-severe plaque psoriasis, a notoriously difficult-to-treat skin condition for which many patients report feeling dissatisfied and frustrated with existing treatment options.

Stelara, the first in a new class of biologics for the treatment of psoriasis, works by targeting interleukin-12 (IL-12) and IL-23. It provides visible and significant improvements in psoriasis severity, and has the added advantage of a convenient dosing regimen for patients - just five injections per year in comparison to a possible 104 injections with etanercept, a widely-prescribed biologic therapy.

Psoriasis, a chronic, non-contagious autoimmune disease resulting in the overproduction of skin cells, affects around 1.5 million people in the UK; up to 20%-30% of whom suffer from the severe form of the disease. Psoriasis can have both a significant physical and psychological impact on patients. Low self-confidence, depression, anxiety and sexual problems are all common, and the impact on quality of life in people with psoriasis is comparable to other chronic illnesses such as heart disease, hypertension, diabetes and cancer, the company noted. In addition, researchers have shown that patients with psoriasis have an increased risk of developing other serious conditions such as cardiovascular disease, diabetes and obesity.

"Psoriasis is an incurable chronic skin condition and many patients hate the way they look and are clinically depressed," said Dony Downs, Consultant Dermatologist, Royal Devon and Exeter NHS Foundation Trust. "Stelara offers both physicians and patients an alternative treatment choice, which is important because psoriasis is not a straightforward disease. Its severity can wax and wane, it can become resistant to any treatment and patients can develop side effects to many of the current alternative treatment options. In clinical practice I have found Stelara to be effective in patients that have failed on other systemic therapies," Dr Downs added.

In clinical studies, treatment with the drug demonstrated a significant, visible improvement in patient's psoriasis with convenient 12 weekly maintenance dosing. This has the potential to give patients with psoriasis greater freedom to live their lives with a significantly reduced burden of disease and without the inconvenience of frequent injections.

"Two-thirds of patients taking Stelara in placebo-controlled trials saw a significant, visible improvement in their psoriasis in as little as 12 weeks," said Christopher Griffiths, Professor of Dermatology at the University of Manchester. "This is reflective of what I have seen in clinical practice, with patients experiencing considerable improvements in skin clearance with the added benefit of a convenient dosing regimen," he noted.