Humira: new treatment option for ulcerative colitis

Humira (adalimumab) can now be prescribed for the treatment and maintenance of remission in adults with moderate to severe active ulcerative colitis (UC), in addition to its use in Crohn's disease.

In addition to its gastrointestinal indications (including ulcerative colitis, pictured), Humira is also licensed for rheumatoid, psoriatic and juvenile idiopathic arthritis and severe chronic plaque psoriasis | SCIENCE PHOTO LIBRARY
In addition to its gastrointestinal indications (including ulcerative colitis, pictured), Humira is also licensed for rheumatoid, psoriatic and juvenile idiopathic arthritis and severe chronic plaque psoriasis | SCIENCE PHOTO LIBRARY

Humira can be considered as an option if the patient is unresponsive or intolerant to standard therapy, including corticosteroids and/or immunosuppressants (including 6-mercaptopurine and azathioprine).

Dose regimen

The induction dose regimen includes an initial dose of 160mg, which may be given as 4 injections in a single day or as 2 injections per day for 2 consecutive days, followed after 2 weeks by a single dose of 80mg. After a further 2 weeks, maintenance doses of 40mg are started and repeated every 2 weeks. All doses are given via subcutaneous injection, which may be self-administered following appropriate training. Treatment should be discontinued if there is no response within 8 weeks.

Phase III trial data

Approval follows the presentation of results from a phase III study at Digestive Disease Week 2011 in Chicago. The double-blind, placebo-controlled study enrolled 494 adults with moderate to severe UC previously treated with conventional therapy. Rates of clinical remission (defined as a Mayo Score of 2 or less with no individual subscore over 1) at weeks 8 and 52 were the co-primary endpoints.

At week 8, significantly more patients achieved clinical remission in the adalimumab group (n=248) than in the control group (n=246): 16.5% vs 9.3% (p=0.019). Similar remission rates were observed at week 52: 17.3% and 8.5%, respectively (p=0.004).

View Humira drug record

Further information: Abbott Laboratories Ltd

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