Yes, for the following indications: severe active Crohn’s disease that has not responded despite a full and adequate course of therapy with a corticosteroid or an immuno-suppressant and for fistulating Crohn’s disease which has failed to respond despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immuno-suppressive therapy).
NICE have approved up to 12 months treatment (in those that respond to induction – see below) and thereafter treatment will be considered only after re-assessment by a specialist.
Ideally patients should be treated with either mercaptopurine or methotrexate for the first 12 months of treatment with infliximab to decrease risk of forming antibodies to infliximab and also to improve the response (according to SONIC trial).
1. Patients with TB or other severe infections or abscesses
2. Possible bowel obstruction
3. Patients with multiple sclerosis or optic neuritis
4. Patients with moderate or severe heart failure
5. Patients with a history of hypersensitivity to infliximab
6. Towards end of pregnancy or breast feeding (stop infliximab before last trimester)
7. Patients with history of lymphoma or cancer
Treatment with corticosteroids may increase risk of infection or abscess formation
1. Induction: 5mg/kg given as an IV infusion over a 2 hour period followed by additional infusions of 5mg/kg at 2 and 6 weeks after the initial dose. If patient is NOT taking thiopurine or methotrexate, then pre-treat with IV hydrocortisone 100mg and oral chlorphenamine 4mg 30 minutes before starting infliximab infusion.
2. Maintenance treatment: every 8 weeks is indicated only if there is a response (based on symptoms, blood tests results, complete or incomplete mucosal healing) to induction treatment. The infusion may be given over 60 minutes followed by 60 minutes observation during maintenance phase of treatment.
3. Re-administration: infliximab can be administered within 16 weeks following the last infusion. After an interval of more than 16 weeks a significant number of patients will develop an allergic reaction that may be decreased by pre-treatment with prednisolone 40mg daily for 2 days before and for 7 days after infusion.
An alternative is to increase dose of infliximab to 10mg/kg and pre-treat with IV hydrocortisone 100mg and anti-histamine. Then decrease dose of infliximab to 7.5mg/kg for second dose and return to 5mg/kg for third and subsequent doses. This approach may be used also if a patient relapses whilst on maintenance treatment.
All patients should be observed for at least 1-2 hours post infusion for side effects:
1. Acute infusion reaction (4%). Usually occurs during first or second infusion. Discontinue infusion immediately if breathlessness or itchy rash occur
2. Other side-effects include headache, ENT infections, abdominal pain, nausea (20-30%)
3. Serious infections (4%), including TB