Remicade approved for use in ulcerative colitis

The monoclonal antibody Remicade (infliximab) has been approved for the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapies.

The extension to Remicade's licence follows the results of two randomised, double-blind, placebo-controlled trials in which it was shown that the group receiving Remicade as part of a combination regimen had a greater proportion of patients in clinical response, in sustained response, in sustained remission and experiencing mucosal healing than the placebo group. Quality of Life scores were also significantly improved in the Remicade group.

The recommended dosage for the treatment of ulcerative colitis in adults is 5mg per kg as an intravenous infusion over two hours, followed by an additional 5mg per kg infusion at two weeks and
six weeks after the first infusion, then every eight weeks thereafter. Clinical response is usually achieved within 14 weeks (ie, after three doses).

Remicade is not recommended for use in patients younger than 17 years.

Further information: Schering-Plough Ltd, Schering-Plough House, Shire Park, Welwyn Garden City, Herts, AL7 1TW. Tel: (01707) 363636.
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