Released 01 July 2009

New psoriatic arthritis drug shows positive results in Phase II trial

Apremilast has shown good results for the treatment of psoriatic arthritis in a Phase II clinical trial.

The drug works by suppressing the effect of proteins known as cytokines, overproduction of which has been found to cause inflammatory diseases like rheumatoid arthritis.

In the new clinical trial, more than 200 patients were randomly assigned to receiving either 20mg of apremilast, 40mg of apremilast or a placebo.

The treatment was given orally twice a day for a period of 12 weeks.

Results at the end of the study showed that at least a 20 per cent improvement was enjoyed by 43.5 per cent of patients in the first group, 35.8 per cent of those in the second and just 11.8 per cent of people taking the placebo.

Most likely side effects were found to be nausea, headache, diarrhoea, fatigue and nasopharyngitis (the common cold).

Dr Randall Stevens, vice-president and head of immunology and inflammation clinical development at drug manufacturer Celgene, said: "The positive data from this Phase II study are encouraging indicators of the potential of apremilast as an innovative oral treatment that may fill a significant unmet need in this debilitating disease.

"The activity of apremilast has now been demonstrated in studies of both psoriasis and psoriatic arthritis including a favourable safety and tolerability profile. Based on these results, we plan to actively pursue registration studies in psoriatic arthritis as a part of our larger development plan in inflammatory diseases."

Psoriatic arthritis is a type of arthritis that usually occurs in people with the skin disease psoriasis. The condition can affect any of the body's 78 joints and causes pain and inflammation in sufferers.

A spokesman for the Arthritis Research Campaign said that the early indications looked interesting and that further trials would reveal the drug’s potential.


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