The Pharmaceutical Journal
Vol 268 No 7196 p597-604
4 May 2002

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Oral cytokine inhibitor effective as anti-inflammatory agent in rheumatoid arthritis

An oral cytokine inhibitor, pralnacasan, has been shown to have anti-inflammatory effects in rheumatoid arthritis. The drug is being developed by Aventis Pharma and Vertex Pharmaceuticals.

Pralnacasan inhibits interleukin-1 beta converting enzyme. This enzyme regulates the production of interleukin-1 beta and interleukin-18, both of which are involved in initiating and sustaining the progression of inflammation. Aventis Pharma says that inhibition of this enzyme may be useful in a number of acute and chronic conditions.

In a phase II trial of patients diagnosed with mild to moderate rheumatoid arthritis, 224 were randomly assigned to receive one of two doses of pralnacasan and 55 were assigned to placebo. Approximately 80 per cent were taking concomitant disease-modifying anti-rheumatic drugs (DMARDs) and 55 per cent were taking corticosteroids at study entry.

Patients receiving pralnacasan showed a trend towards a dose-dependent improvement in signs and symptoms of the disease after 12 weeks. An analysis of those not concomitantly receiving DMARDs or cortico-steroids showed similar trends, indicative of pralnacasan's anti-inflammatory effect.

The drug had good tolerability, both alone and in combination with other drugs for rheumatoid arthritis, when administered for up to 24 weeks, the company says.