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Results from a late-stage study of the fully human monoclonal antibody Humira� (adalimumab) reveal that the drug reduces hospitalisations for people with Crohn’s disease, manufacturer Abbott Laboratories claims.
In a presentation at the Digestive Disease Week meeting in Washington DC, USA, the company announced the results from a post-hoc analysis of the 854-patient phase III CHARM study, which showed that those with moderate to severely active Crohn’s treated with Humira were almost 60% less likely than patients on placebo to be hospitalised (5.9% versus 13.9%).
The firm noted that people with Crohn’s may be hospitalised for reasons ranging from fever and vomiting to intestinal obstruction and infections, while hospitalisation is responsible for some 60% of the disease’s cost, with the average stay costing some $37,000 per patient.
Crohn’s involves chronic inflammation of the gastrointestinal tract and affects some one million people in North America and Europe. The company said that because there is no medical or surgical cure, “maintenance of remission from disease flares is one of the primary goals of treatment”.
In February Humira became the first biological to receive FDA approval for treating Crohn’s in nine years and the only one patients can administer themselves. The drug is also approved for treating rheumatoid and psoriatic arthritis, as well as ankylosing spondylitis. Last month Abbott filed Humira with US and European regulators for psoriasis in a bid to gain approval for a fifth indication of the drug.
Belgian drug company UCB also presented data at the DDW meeting which demonstrated long-term response and remission in Crohn’s patients treated with its drug 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.
PharmaTimes 23/5/2007
