Authors' objectives:

The objectives of the review were to address the following questions:

- How effective is infliximab as a second- or third-line treatment for severe active Crohn's disease in adults who have not responded to conventional treatment?

- How effective is infliximab at reducing the number of draining fistulae in adult patients with fistulising Crohn's disease who have not responded to conventional treatment?

- What is the frequency and severity of adverse effects associated with the use of infliximab?

- What adverse events are associated with repeated treatment with infliximab?

- How cost-effective is infliximab for the above indications compared with standard practice?

Authors' results and conclusions: The use of infliximab in chronic active Crohn's disease resistant to conventional treatment was evaluated in three trials involving 754 patients. Only the two smaller trials (n = 181) had been completed. The larger ACCENT I trial (n = 573) has yet to be fully reported. A single dose of infliximab was associated with significant treatment benefit at week 4 (number needed to treat (NNT) = 3 for response defined as a >= 70-point reduction in Crohn's Disease Activity Index), with approximately 30% of patients achieving remission of their symptoms at this time (NNT = 4). Benefit was, however, short-lived with the majority of patients relapsing beyond week 12. Data on repeated treatment were less clear. The evidence suggested that a positive treatment effect was seen, but current data were too limited to confirm this. The full results from the ACCENT I trial will address this. Only one trial evaluated the use of infliximab in fistulising Crohn's disease. A three-dose treatment course resulted in complete healing of perianal/abdominal fistulae for more than 21 days in 46% of patients treated with infliximab versus 13% treated with placebo (NNT = 4). Again, treatment benefit was short-lived, with a median duration of 3 months. Data on repeated treatment are not currently available but will be provided by the ACCENT II trial.

Authors' recommendations: Infliximab is a specialised treatment requiring intravenous administration. Patients being considered for infliximab treatment need to be fully assessed by specialists experienced in the management of severe Crohn's disease. These patients will have disease that is not amenable to conventional medical and surgical management. Use of infliximab is, therefore, likely to be limited to a small group of patients, in whom benefits over existing treatment can be expected.

Authors' methods: Systematic review, Economic evaluation

Project Status: Completed

URL for project: http://www.hta.ac.uk/1227

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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