atients in the UK with moderate-to-severe forms of psoriasis can now get treatment with Johnson & Johnson unit Janssen-Cilag’s novel biologic Stelara, following its market launch yesterday.
According to the firm, around 1.5 million people in the UK have psoriasis, and around 20%-30% of cases are classed as severe. Current therapies available for the treatment of the disease include Wyeth's Enbrel (etanercept), which dominates the psoriasis market, Abbott Laboratories’ Humira (adalimumab) and J&J’s own Remicade (infliximab).
But Stelara (ustekinumab) is the first in a new class of biologics targeting the cytokines interleukin-12 and -23. It won European approval last month for the treatment of adult patients who have failed to respond to other systemic therapies, after Phase III data showed that it induced a “visible improvement” in patients’ psoriasis and their quality of life, the firm said.
Specifically, in two Phase III studies submitted as part of the application, two-thirds of patients treated with Stelara experienced significant skin clearance (75%) by week 12 and sustained efficacy through at least week 76 with maintenance therapy every 12 weeks. Moreover, in a head-to-head Phase III trial with the market leader Enbrel, Stelera was shown to be more effective in reducing disease severity after 12 weeks of treatment.
Less frequent dosing
And as well as its proven effectiveness, the drug has the added advantage over its rivals on the market of a more convenient dosing regimen, as patients need just five doses a year compared to as many as 104 injections with current biologic therapies, a trait many analysts believe could help Stelara become a blockbuster.
“Two-thirds of patients taking Stelara in placebo-controlled trials saw a significant, visible improvement in their psoriasis in just 12 weeks” said Chris Griffiths, Professor of Dermatology at the University of Manchester, commenting on the drug’s benefits. “This improvement is sustained for up to a year-and-a-half with just five doses a year, allowing patients to get on with their lives,” he added.
A spokeswoman for the company told PharmaTimes UK News that the annual cost of treatment with Stelara is similar to that of the commonly used biologics in the UK, but, at around £9,300 per patient per year, it “provides significantly better outcomes for less cost compared with standard of care treatment”.