Advanced Therapies in Crohn's Disease
Remicade®/Johnson & Johnson Innovative Medicine/BioAdvance® (CD 2003, UC 2006)
Remdantry®/Celltrion/Celltrion Connect (2014 previously Inflectra, 2025 renamed Remdantry)
Renflexis®/Organon/Harmony by Organon™ (2018)
Avsola®/Amgen/Entrust (2025)
Remsima™/Celltrion/Celltrion Connect™ (2024)
Ixifi®/Pfizer/PfizerFlex (2024)
Monoclonal antibody
Tumour necrosis factor (TNF) blocking agent
IBD causes the immune system to produce an excess amount of TNFα, which causes inflammation. Anti-TNFα is a protein that works to bind TNFα and block inflammation.
Humira®/AbbVie/AbbVie Care (2004)
Abrilada®/Pfizer/Pfizer Flex (2022)
Amgevita®/Amgen/Entrust (2025)
Hadlima®/Organon/Harmony by Organon™ (2021)
Hulio®/Biocon/My Biocon Biologics (2022)
Hyrimoz®/Sandoz/Xpose® (2021)
Idacio®/Fresenius Kabi/KabiCare® (2021)
Simlandi™/JAMP Pharma/JAMP Care (2022)
Yuflyma®/Celltrion/Celltrion Connect™ (2022)
Monoclonal antibody
Tumour necrosis factor (TNF) blocking agent
IBD causes the immune system to produce an excess amount of TNFα, which causes inflammation. Anti-TNFα is a protein that works to bind TNFα and block inflammation.
Stelara®/Johnson & Johnson Innovative Medicine/BioAdvance® (CD 2017, UC 2020)
Wezlana/Amgen/Entrust (2025)
Steqeyma/Celltrion/Celltrion Connect (2024)
Otulfi®/Fresenius Kabi/KabiCare® (2024)
Monoclonal antibody interleukin (IL)-12/23 inhibitor
Targets an overactive immune system by blocking two receptors called IL-12 and IL-23. By blocking these receptors, cells are slowed down, which reduces inflammation.
Monoclonal antibody integrin receptor blocker
Skyrizi®/AbbVie/AbbVie Care (2019)
Monoclonal antibody interleukin (IL)-23 inhibitor
Targets IL-23 protein receptor, which is one of the proteins responsible for inflammation. Blocking this receptor contributes to reducing inflammation.
Rinvoq/Abbvie/Abbvie Care (2023)
JAK Inhibitor
JAKs are intracellular enzymes that activate the body’s immune response causing inflammation. JAK inhibitors block this pathway. Works by attaching to the JAK enzyme to lower its activity and to decrease inflammation in the body.
Omvoh™/Eli Lilly and Company/LillyPlus® (2025)
Tremfya®/Johnson & Johnson Innovative Medicine/BioAdvance® (CD UC 2025)
Monoclonal antibody interleukin (IL)-23 inhibitor
Chest X-ray
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)
Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations: HAV, HBV, HPV, and Tdap
Refer to CANIBD Vaccination Guidelines for further information.12
Use with caution in patients with chronic or recurrent infection.
IV infusion
SC injection
Infusion centre
Home
Adult Dosing:
Weight-based dosing. Standard dose is 5 mg/kg. Dose escalation to 10mg/kg may be considered.
Induction: wk 0, wk 2, wk 6
Then maintenance every 8 wks*
Patients who experience a disease flare or are non-responsive, a shorter infusion interval may be considered.
Infliximab SC (Remsima™) – For patients who have completed an induction.
IV infliximab: Maintenance dosing regimen of 120 mg (given as one subcutaneous injection) once every 2 wks, starting 4 wks following completion of an induction regimen.
For patients already receiving intravenous infliximab maintenance therapy: Maintenance therapy with IV infliximab and who are switching to SC maintenance therapy, the first dose of may be administered 8 wks after the last infusion.
Paediatric Dosing:
(≥ 9 years of age) with moderately to severely active Crohn’s disease:
5 mg/kg given as an induction regimen at 0, 2 and 6 wks followed by a maintenance regimen of 5 mg/kg every 8 wks.
The safety and efficacy of Remicade® has not been established in paediatric patients with Crohn’s disease <9 years of age.
3-4 hrs
Those who do not experience a reaction can be infused <2 hrs
SC Injection – 5 min
Cervical cancer screening – pap tests per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
Chest X-ray
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)
Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations: HAV, HBV, HPV, and Tdap
Refer to CANIBD Vaccination Guidelines for further information.12
Use with caution in patients with chronic or recurrent infection.
SC injection
Home
Infusion centre is also available
Adult Dosing:
Induction:
160 mg, 80 mg,
40 mg, wk 0, wk 2, wk 4
Then maintenance 40 mg every 2 wks*
Patients who experience a disease flare or are non-responsive, dose escalation may be considered.
Paediatric Dosing:
13 to 17 years of age
≥ 40 kg: 160 mg at Wk 0, 80 mg at Wk 2. Maintenance dose regimen is 20 mg every other week beginning at Wk 4.
For paediatric patients who experience a disease flare or non-response, dose escalation to 40 mg every other week may be considered.
<15 min
Cervical cancer screening – pap test as per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
Chest X-ray
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)
Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations: HAV, HBV, HPV, and Tdap
Refer to CANIBD Vaccination Guidelines for further information.12
Use with caution in patients with chronic or recurrent infection.
IV infusion x 1
Then SC injection
Infusion centre
Home
Induction:
weight based at 6mg/kg
up to 55kg- 260mg
>55kg-85kg- 390mg
>85 kg- 520mg
Then maintenance 90 mg SC every 8 wks*
Following the first SC dose at 8 wks, those with low inflammatory burden may receive 90mg SC every 12 wks at the discretion of the HCP.
Patients who experience a disease flare or are non-responsive, a shorter infusion interval (q 4 wks) may be considered.
1–2 hrs for initial IV infusion
SC injection <15 min
Cervical cancer screening – pap test as per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
TB screening should be considered.
Recommend all immunizations are current.
IV infusion or SC injection
Infusion centre or Home
Induction:
300 mg IV wk 0, wk 2, wk 6
Then maintenance 300 mg IV every 8 wks
OR
Following at least 2 IV infusions, 108 mg SC every 2 wks†
Patients who experience a disease flare or are non-responsive, a shorter infusion interval (q 4 wks) may be considered.
1–2 hrs for infusion
<5 min SC injection
Patients should be monitored for any new onset or worsening of neurological signs and symptoms
Liver enzymes – transaminases and bilirubin.
Cervical cancer screening – pap test as per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)
Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations HAV, HBV, HPV, and Tdap.
Refer to CANIBD Vaccination Guidelines for further information.12
Use with caution in patients with chronic or recurrent infection.
Liver tests as per routine patient management prior to initiating therapy.
IV infusion x 3 then on-body (SC) injector (OBI) with pre-filled cartridge
Infusion centre
Home
Induction:
600 mg IV at wk 0, wk 4 and wk 8
Then 360 mg subcutaneous (OBI) at wk 12 and every 8 wks thereafter.
Minimum 1 hr infusion
OBI injection <15 min
Cervical cancer screening – pap test as per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
Liver enzymes as part of your routine blood work.
TB skin test, blood work (baseline CBC, liver enzymes, lipids, CK, renal function, Hepatitis B serology)
Shingrix zoster, recommend receiving live vaccines prior to starting therapy.
Recommend all immunizations are current.
Oral
Home
Induction:
45mg once daily for 12 wks
Then maintenance 15mg or 30mg once daily.
5 mins
Baseline blood work – CBC
Liver enzymes, lipids, CK, renal function and Hepatitis B serology
Blood work q 3 months
Including CBC, liver enzymes, lipids, CK, and renal function
Cervical cancer screening – pap test as per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
TB skin test, blood work (baseline CBC, liver enzymes, lipids, CK, renal function, Hepatitis B serology)
Ensure all immunizations are current. Refer to CANIBD Vaccination Guidelines for further information.12
IV Infusion X3
Then SC injection
Infusion centre
Home
Induction:
900 mg IV mg wk 0, wk 4, wk 8
Then maintenance 300 mg SC every 4 weeks.
Minimum 30-min infusion
Self-injection 5 min
Evaluate liver enzymes and bilirubin at baseline and every 1–4 months during induction (including induction period, if applicable) and thereafter according to standard practice.
Cervical cancer screening – pap test as per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
TB skin test
Baseline blood work (baseline CBC, renal and liver enzymes, HBV)
Ensure all age appropriate immunizations are current.
Infusion centre
Home
Adult Dosing
Induction:
200mg IV over one hour at wk 0,4 and 8
Or
400mg SC injection at wk 0, 4 and 8. Each 400mg dose is given as two injections of 200mg
Then maintenance 100mg SC at week 16 and every 8wks thereafter
A dose of 200mg SC at wk 12 and every 4 wks thereafter may be considered for patients who do not show adequate therapeutic benefit or according to clinical judgement.
No dose adjustment is needed in the elderly.
Minimum 1 hour infusion and < 5 min SC injection
Blood work q 3 months including CBC, liver enzymes, lipids, and renal function
Cervical cancer screening – pap test as per provincial guidelines
Annual skin exam – skin malignancies
Influenza vaccine recommended
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
*Dose and frequency adjustments can be made at the discretion of the practitioner.
†Frequency of infusions can be adjusted at the discretion of the practitioner.
TB: Tuberculosis, CBC: complete blood count, HBV: hepatitis B virus, HAV: hepatitis A virus, HPV: Human papillomavirus, Tdap: tetanus, diphtheria, and pertussis, IV: intravenous, SC: subcutaneous, wk: week, hrs: hours, min: minutes.
IV: intravenous, wk: week, TB: tuberculosis, CHF: congestive heart failure, Anti-TNF: Anti-tumour necrosis factor, HBV: hepatitis B virus, NMSC: non-melanoma skin cancer, CPK: Creatine phosphokinase
Approved for use in paediatric patients.
Data supporting the efficacy of anti-TNF therapy in the elderly is limited with some studies showing similar results in elderly and younger onset IBD and others suggesting lower efficacy.
Caution should be used when treating the elderly.
Data on safety of anti-TNF therapy reports increased rates of adverse events in elderly patients.
Anti-TNF therapy is not suitable for patients with history of either CHF and recent malignancy (< 2 years).
The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend:13
Women with IBD who are pregnant or attempting conception should continue biosimilar to existing biologics.
In women with IBD who are pregnant or attempting conception, we recommend continuing maintenance anti-TNF therapy throughout pregnancy.
In women with IBD who are pregnant or attempting conception, we suggest continuing maintenance combination therapy with an anti-TNF and thiopurine therapy throughout pregnancy.
In women with inflammatory bowel disease who are pregnant or attempting conception, we suggest continuing maintenance thiopurine therapy as data do not demonstrate an increased risk of congenital malformation or infant infections.
Please refer to the original publication for additional information.13
The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend: 13
Mothers with IBD currently on anti-TNF agents may breastfeed.
Please refer to the original publication for additional information.13
Approved for use in paediatric patients.
Data supporting the efficacy of anti-TNF therapy in the elderly is limited with some studies showing similar results in elderly and younger onset IBD and others suggesting lower efficacy.
Caution should be used when treating the elderly.
Data on safety of anti-TNF therapy reports increased rates of adverse events in elderly patients.
Anti-TNF therapy is not suitable for patients with history of either CHF and recent malignancy (< 2 years).
The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend:13
Women with IBD who are pregnant or attempting conception should continue biosimilar to existing biologics.
In women with IBD who are pregnant or attempting conception, we recommend continuing maintenance anti-TNF therapy throughout pregnancy.
In women with IBD who are pregnant or attempting conception, we suggest continuing maintenance combination therapy with an anti-TNF and thiopurine therapy throughout pregnancy.
In women with inflammatory bowel disease who are pregnant or attempting conception, we suggest continuing maintenance thiopurine therapy as data do not demonstrate an increased risk of congenital malformation or infant infections.
Please refer to the original publication for additional information.13
The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend: 13
Mothers with IBD currently on anti-TNF agents may breastfeed.
Please refer to the original publication for additional information.13
Not currently approved for paediatric use.
At present, there is not enough data to determine the safety in the elderly.
In women with IBD who are pregnant or attempting conception, we suggest continuing maintenance ustekinumab therapy throughout pregnancy.
Women with IBD who are pregnant or attempting conception should continue biosimilar to existing biologics.13
Not currently approved for paediatric use.
Clinical trials of vedolizumab did not include sufficient numbers of subjects aged 65+ to determine whether they respond differently from younger subjects.
Not currently approved for paediatric use.
Clinical trial analysis in this limited patient population found no clinically meaningful difference in risankizumab exposure between patients 65 years of age or older and adult population.
Women with IBD who are pregnant or attempting conception should continue anti-IL23 therapy throughout pregnancy.13
Not currently approved for paediatric use.
For patients older than 65 years of age, the recommended maintenance dose is 15mg once daily.
Women with IBD who are pregnant or attempting conception should continue anti-IL23 therapy throughout pregnancy.13
Mothers with IBD currently on anti-IL 12/23 and anti-IL23 agents may breastfeed.13
Not currently approved for paediatric use.
Women with IBD who are pregnant or attempting conception should continue anti-IL23 therapy throughout pregnancy.13
CHF: congestive heart failure, anti-TNF: anti-tumour necrosis factor, IBD: inflammatory bowel disease, IL: interleukin