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The Pharmaceutical Journal
Vol 268 No 7197 p633-640
11 May 2002

Related websites
NICE (www.nice.org.uk)
The Lancet (www.thelancet.com)

NICE recommends use of infliximab for patients with severe active Crohn's

Maintenance infliximab of benefit in Crohn's disease

Infliximab (Remicade) should be made available to some patients with severe active Crohn's disease, the National Institute for Clinical Excellence has recommended.

The guidance, which was issued to the National Health Service in England and Wales last week, states that for treatment to be recommended:

The patient must have severe active Crohn's disease (a score of 300 or more on the Crohn's Disease Activity Index or at least eight to nine on the Harvey-Bradshaw Index)
The patient's condition must be refractory to treatment with immunomodulators and corticosteroids or the patient must be intolerant of, or experienced toxicity from, these treatments
Surgery must be inappropriate for the patient

NICE recommends that infliximab should not be used to treat patients with fistulising Crohn's disease who have not fulfilled all the other criteria for severe active Crohn's disease.

The guidance adds that treatment with infliximab can be repeated for those patients who match the criteria and who have responded to initial treatment but whose condition then relapses.

It notes that delayed hypersensitivity reaction has been observed in 25 per cent of patients with Crohn's disease who were retreated with infliximab after a two- to four-year treatment-free period. However, the risk of hypersensitivity reaction following readmission after a drug-free period of 15 weeks to two years is unknown.

NICE says that, on the basis of its guidance, around 1,050 patients would be eligible for treatment. Assuming that the drug and treatment costs for an average patient (60kg) is around £1,457, the average number of episodes of treatment in one year is 2.2 and the response rate is 48 per cent, the cost of treatment for people who currently have severe chronic active Crohn's disease is estimated to be around £2.5m for the first year.

NICE suggests that further studies are required to investigate the role of infliximab in long-term prevention of surgery for patients with Crohn's disease.

Copies of the full guidance are available on the NICE website (www.nice.org.uk).

Infliximab is a monoclonal antibody that inhibits the activity of tumour necrosis factor alpha, a pro-inflammatory mediator thought to play a central role in the pathogenesis of Crohn's disease.

Maintenance infliximab of benefit in Crohn's disease

Patients with Crohn's disease treated with maintenence infliximab (Remicade) therapy are more likely to remain in remission after a year of treatment than those given placebo, researchers report. Infliximab is not currently licensed in the United Kingdom for maintenance treatment of Crohn's disease.

Dr Stephen Hanauer, University of Chicago Medical Centre, and colleagues assigned 573 patients with a Crohn's disease activity index score of at least 220 to receive an infusion of infliximab 5mg/kg. Those patients responding to treatment (58 per cent) after two weeks were randomly assigned to receive either infliximab or placebo at weeks two and six and then every eight weeks thereafter. The researchers say that maintenance treatment with infliximab infusions every eight weeks was more effective than subsequent treatment with placebo among patients who responded to a single infusion of infliximab. Patients assigned to maintenance infliximab were more likely to maintain clinical responses for a longer period, remain in remission and to discontinue corticosteroids. More than twice as many patients in the infliximab maintenance group remained in remission from weeks 14 to 54 than those maintained on placebo. Maintenance therapy with infliximab was also well tolerated.

The researchers comment that failure of other treatments had occurred in many of the patients who participated in the study and conclude: "Patients thought previously to be refractory have an additional therapeutic option."

The study is published in The Lancet (2002;359:1541).