This guidance relates only to the use of infliximab within its marketing authorisation, for the treatment of acute exacerbations of severely active ulcerative colitis. It relates to an induction course of three doses of infliximab.
Infliximab is recommended as an option for the treatment of acute exacerbations of severely active ulcerative colitis only in patients in whom ciclosporin is contraindicated or clinically inappropriate, based on a careful assessment of the risks and benefits of treatment in the individual patient.
In people who do not meet the criterion in 1.1, infliximab should only be used for the treatment of acute exacerbations of severely active ulcerative colitis in clinical trials.