Initiation of Immunomodulators

Objective: Appropriate initiation and use of immunomodulators (Thiopurines and Methotrexate)

Patient population: Individuals with a known diagnosis of IBD

Highlight Box

Methotrexate should not be used in females wanting to become pregnant (discuss alternate therapy prior to family planning).

Imuran and 6MP can be continued as ordered throughout pregnancy and breastfeeding.


This care protocol provides a general guideline for initiating immunomodulators (also called immunosuppressants) in adults with inflammatory bowel disease. 

IBD Provider:

1. Prior to starting an immunomodulator, consider TPMT testing, EBV IgG screening. It is important to remember that patients may need to switch to a different immunomodulator or require biologic therapy. Refer to the Induction of Advanced Therapy for pre-biologic work-up.

2. At the time of the medication initiation appointment, the patient is to be given:

a. A patient information sheet and instructions for taking the medication -  Thiopurines (Azathioprine or 6-mercaptopurine for IBD, Azathioprine Patient Instructions, 6-Mercaptopurine Patient Instructions); Methotrexate (Methotrexate Information sheet, Methotrexate Patient Instructions) (PACE QPI 22,23)

b. Bloodwork requisitions:

  • A new start immunomodulator lab requisition to be done every week for 1 month, monthly for the first 6 months, then 3-monthly thereafter. This should include CBC, CRP, liver biochemistry, +/- albumin  electrolytes and creatinine. (PACE QPI 12)
  • 6-TG and 6-MMP levels to be done at 3 months (physician discretion) 
  • Collection kit for fecal calprotectin at baseline, 3 months, 6 months, and then 6-monthly thereafter.

 3. After the patient has been on an immunomodulator for 3 months, assess for clinical, and biochemical (including fecal calprotectin response). (Harvey Bradshaw Index) (Partial Mayo Scoring Index). (PACE QPI 15)

4. If there is inadequate response (including the inability to wean corticosteroids), consider dose optimization (+/- with the assistance of 6-TG, 6-MMP levels), or switch to an alternative therapy. See Loss of Response of Partial Response Protocol

5. Skin cancer surveillance is to be performed by a family physician or dermatologist on an annual basis.

Support Staff:

6. Arrange a follow-up assessment (phone/clinic visit/telehealth) clinic appointment in 3-4 months.

Download PDF version

Go Back to IBD Clinical Care Pathways