Abbott Laboratories has presented results from a late-stage study of its fully human monoclonal antibody Humira which reveals that the drug reduces hospitalisations for people with Crohn's disease.
The company announced the results from a post-hoc analysis of the 854-patient Phase III CHARM study at the Digestive Disease Week meeting in Washington DC which showed that those with moderate to severely active Crohn's disease treated with Humira (adalimumab) were almost 60% less likely than patients on placebo to be hospitalised (5.9% versus 13.9%). Abbott noted that people with Crohn's disease may be hospitalised for a variety of reasons, from fever and vomiting to intestinal obstruction and infections, and hospitalisation is responsible for approximately 60% of the disease’s cost, with the average stay working out at about $37,000 per patient.
Crohn's disease, which involves chronic inflammation of the gastrointestinal tract, affects more than one million people in North America and Europe and “there is no medical or surgical cure,” noted Abbott, so “maintenance of remission from disease flares is one of the primary goals of treatment”.
The data is not going to harm sales of Humira, which in February became the first biologic to receive US Food and Drug Administration approval for the treatment of Crohn's disease in nine years and the only one that patients can administer themselves. It is also approved for the treatment of both rheumatoid and psoriatic arthritis, as well as ankylosing spondylitis, an arthritis of the spine and last month Abbott has filed Humira with US and European regulators for psoriasis in a bid to get approval for a fifth indication of the drug.
Promising data for UCB’s Cimzia
Meantime, UCB also presented data at the DDW meeting which demonstrated long-term response and remission in Crohn's disease patients treated with the Belgian firm’s Cimzia (certolizumab pegol).
At week 80, the study showed that more than 85% of the patient subgroup who continuously received Cimzia 400mg subcutaneously every four weeks maintained clinical response, with nearly 74% of these achieving remission. The compound was well-tolerated throughout the study, UCB noted.
However Cimzia is still playing catch-up with Humira and has much ground to make up in terms of Crohn’s disease. A US launch could be delayed by up to two years as the FDA has insisted on the need to carry out an additional trial, the results of which will only be available near the end of 2008.