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J&J's Stelara proves effective in psoriatic arthritis

An approval in this new indication would bring it level with Enbrel and Humira

Johnson & Johnson's psoriasis drug Stelara is also effective in cases of psoriatic arthritis, according to a phase III trial presented at the European League against Rheumatism (EULAR) meeting in Berlin this week.

The results of the 615-patient study showed that Stelara (ustekinumab) achieved significant reductions in joint symptoms after 24 weeks' treatment in psoriatic arthritis, a condition which occurs in around 15 per cent of psoriasis patients.

"This is a challenging disease that causes great distress for those afflicted, for which we currently have too few treatment options," said the lead investigator in the study, Iain McInnes of the University of Glasgow in Scotland.

Stelara is a first-in-class interleukin-12/23 inhibitor and has been showing robust growth since it was launched onto the psoriasis market in 2009, with sales almost doubling last year to reach $738m. 

The product's closest competitors in the $5.4bn psoriasis market are Amgen/Pfizer's Enbrel (etanercept) and Abbott/Eisai's Humira (adalimumab), both tumour necrosis factor (TNF) inhibitors, which have roughly a third of the market apiece. 

Stelara has been gaining ground however, thanks to a sizeable proportion of patients who do not respond to TNF blockers and a favourable administration regimen that requires only five doses a year. Approval in psoriatic arthritis would help J&J grow sales and market share, with Datamonitor predicting that the product will be pulling in more than $1.5bn by 2016. Enbrel and Humira are both already approved for psoriatic arthritis. 

The results of the latest PSUMMIT 1 trial indicated that between 42 and 40 per cent of Stelara-treated patients achieved a 20 per cent or greater improvement in arthritis symptoms using the American College of Rheumatology (ACR) scale - depending on the dose used - compared to 23 per cent of the placebo group.

J&J's drug was also significantly more effective at achieving 50 per cent and 70 per cent ACR scale improvement rates compared to placebo, according to the investigators.

J&J is conducting a second phase III study of Stelara in psoriatic arthritis and - if the results of the second trial are positive - will press ahead with regulatory filings in the new indication.

"We look forward to additional data from the phase III psoriatic arthritis clinical development programme to allow us to more fully assess the efficacy and safety of Stelara in the treatment of this complex inflammatory disease," said McInnes.

7th June 2012

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