Abbott's marketed anti-inflammatory drug Humira (adalimumab) has been successful in a phase III study testing the product as a therapy for ulcerative colitis (UC), according to the company.
The study results, which were presented this week at the Digestive Disease Week scientific conference in Chicago, showed that Humira met the primary endpoint of clinical remission in adults with moderate to severe forms of the chronic autoimmune disease.
Abbott recently submitted US and European marketing applications seeking approval for Humira for the treatment of UC, which is characterised by inflammation and ulceration in the lining of the colon or large intestine that results in symptoms including abdominal cramping, rectal bleeding, increased bowel movements and diarrhoea. The condition affects about 700,000 people in the US. Current therapies include corticosteroids, immunosuppressants and surgery.
Abbott's phase III Humira study enroled 494 adults with UC who had not responded well to conventional therapy. Of the 248 patients treated with Humira, 16.5 per cent achieved clinical remission, compared to 9.3 per cent on placebo at week eight. At week 52, 17.3 per cent of patients in the treatment group achieved clinical remission compared to 8.5 per cent on placebo.
Humira, a fully human monoclonal antibody, is already approved for moderate to severe rheumatoid arthritis; moderate to severe polyarticular juvenile idiopathic arthritis in children four years of age and older; psoriatic arthritis; ankylosing spondylitis; moderate to severe Crohn's disease in adults who have not responded well to other treatments; and chronic plaque psoriasis.
In the first quarter of 2011, global Humira sales totalled more than $1.6bn, an increase of nearly 18 per cent on the prior year and ahead of analyst expectations. The drug competes with Centocor's Remicade (infliximab) and Amgen and Pfizer's Enbrel (etanercept).