PATIENTS WITH Crohn’s disease are less likely to be hospitalised if they are using Tysabri, according to figures produced by the drug’s developers, Irish biotech group Elan and US-based Biogen Idec.
Results released yesterday of a new analysis of three late-stage clinical trials showed Tysabri benefited patients with moderate to severe Crohn’s – an inflammatory disease of the intestine and bowel.
The data showed a 35 per cent drop in the need for hospitalisation during the initial treatment period and a 44 per cent fall in such a requirement for those on longer-term therapy.
Tysabri is marketed primarily as a treatment for multiple sclerosis (MS), where its efficacy has seen it take market share of over 10 per cent in the two years since it returned to market. It had earlier been withdrawn after being implicated in cases of progressive multifocal leukoencephalopathy (PML), a potentially fatal brain disease.
The US regulator, the Food and Drug Administration (FDA), licensed Tysabri for the treatment of Crohn’s in January 2008. The condition is said to affect as many as half a million patients in the US. There is no medical cure, and many patients struggle to find a consistently effective treatment.
“Hospitalisation accounts for a large proportion of the cost of Crohn’s disease management,” said Dr Corey Siegel, director, Inflammatory Bowel Disease Center, Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, who led the analysis.
“Therefore, we were encouraged to see that Tysabri reduced hospitalisation rates, particularly in the more difficult-to-treat subsets of patients.”
To date, Crohn’s has accounted for a very small part of the sales of Tysabri. The drug is under review by European regulators after it emerged last week that 23 patients have contracted PML since its introduction. Only last month, the FDA said there were only 13 instances of the disease.
The FDA and Biogen have accepted that the longer people are on Tysabri, the greater the risk of contracting PML. – (Additional reporting Bloomberg)
