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).
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).
Further information: Abbott Laboratories Ltd