Adalimumab (Humira) is an anti-tumor necrosis factor (TNF) agent that is approved for both inducing and maintaining remission in moderately to severely active Crohn’s disease. Small open-label trials and case reports suggest that it can induce responses in both patients who had been treated with this class of drugs and those who had not been so treated, and anti-TNF-treated patients with active ulcerative colitis. This led to a phase III trial sponsored by the pharmaceutical company Abott. In it, of the 248 patients treated with 40mg every other week, 16.5 percent achieved clinical remission compared to 9.3 percent on placebo at week 8 p=0.019). At week 52, 17.3 percent achieved clinical remission compared to 8.5 percent on placebo (p=0.004). These results were statistically significant compared to placebo. The safety results was as expected and known from other studies of Humira.
On April 11, 2012 the European Commission has approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy. In the USA, in May of 2012, Humira is approved for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Plaque Psoriasis but not for ulceratuve colitis.
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