Guidance 1.1 Infliximab is recommended for the treatment of patients with severe Crohn's disease who fulfil all three of the following criteria:
- Patients who have severe active Crohn's disease. These patients will already be in very poor general health with weight loss and sometimes fever, severe abdominal pain and usually frequent (34 or more) diarrhoeal stools daily. They may or may not be developing new fistulae or have extra-intestinal manifestations of the disease. This clinical definition normally corresponds to a Crohn's Disease Activity Index (CDAI) score of 300 or more and a Harvey-Bradshaw Index of 8/9 or above.
- Patients whose condition has proved to be refractory to treatment with immunomodulating drugs (e.g. azathioprine or 6-mercaptopurine, methotrexate) and corticosteroids, or who have been intolerant of, or experienced toxicity from, these treatments.
- Patients for whom surgery is inappropriate (e.g. because of diffuse disease and/or a risk of short bowel syndrome).
1.2 Treatment can be repeated for those patients who match the above criteria and have responded to the initial treatment course, but then relapsed. A decision about whether or not to re-administer infliximab after the first course or subsequently should be made only after discussion with the patient who has been fully informed of the potential risks and benefits of repeated therapy (episodic treatment).
1.3 Infliximab should be prescribed by a gastroenterologist experienced in the management of Crohn's disease.
1.4 Infliximab is not recommended for patients with fistulising Crohn's disease who do not have the other criteria for severe active Crohn's disease.