Treatment Options Overview

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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Remicade®/Janssen/BioAdvance® (CD 2003, UC 2006)
Inflectra®/Pfizer/PfizerFlex (2014)
Renflexis®/Organon/Harmony by Organon(2018)
Avsola®/Amgen/Enliven Services (2020)
Remsima®/Celltrion/Celltrion Connect(2024)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Crohn’s disease
Ulcerative colitis

CLASS

Monoclonal antibody
Tumour necrosis factor (TNF) blocking agent

ACTION

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.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Humira®/AbbVie/AbbVie Care (2004)

Abrilada®/Pfizer/Pfizer Flex (2022)

Amgevita®/Amgen/Enliven Services (2021)

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)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Crohn’s disease
Ulcerative colitis

CLASS

Monoclonal antibody
Tumour necrosis factor (TNF) blocking agent

ACTION

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.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Stelara®/Janssen/BioAdvance® (CD 2017, UC 2020)

Wezlana™/Amgen/EnlivenServices (2024)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Crohn’s disease
Ulcerative colitis

CLASS

Monoclonal antibody interleukin (IL)-12/23 inhibitor

ACTION

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.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Entyvio®/Takeda/OnePath® (2015)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Crohn’s disease
Ulcerative colitis

CLASS

Monoclonal antibody integrin receptor blocker

ACTION

Blocks integrin α4β7 protein that is found on the surface of white blood cells, thereby reducing intestinal inflammation. Inflammation elsewhere in the body is unaffected.
           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Simponi®/Janssen/BioAdvance® (2013)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Ulcerative colitis

CLASS

Monoclonal antibody tumour necrosis factor (TNF) blocking agent

ACTION

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.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Xeljanz®/Pfizer/PfizerFlex™ (2018)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Ulcerative colitis

CLASS

Janus kinase (JAK) inhibitor

ACTION

JAKs are intracellular enzymes/proteins that activate the body’s immune response, causing gut inflammation. JAK inhibitors block this pathway. Works by attaching to the JAK enzyme to lower its activity and to decrease inflammation in the body.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Rinvoq/Abbvie/Abbvie Care (2023)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Crohn’s disease
Ulcerative colitis

CLASS

JAK Inhibitor

ACTION

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.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Zeposia®/Bristol Myers Squibb/Bristol Myers Squibb Access Support® (2022)

 

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Ulcerative colitis

CLASS

Sphingosine 1 phosphate (S1P) modulator

ACTION

Binds with high affinity to S1P receptor 1 and reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood and lymphocyte migration into the intestines. Decreases the cells involved in immune response.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Omvoh/Eli Lilly and Company/LillyPlus® (2023)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Ulcerative colitis

CLASS

Interleukin-23 (IL-23) p 19 antagonist

ACTION

Humanized immunoglobulin G4 (IgG4) monoclonal antibody that binds with high affinity and specificity to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Velsipity®/Pfizer/PfizerFlex™ (2024)

APPROVED CLINICAL INDICATIONS

(may vary within provinces – refer to local patient support program)

Ulcerative colitis

CLASS

Selective Sphingosine 1-phosphate (S1P) receptor modulator

ACTION

Binds with high affinity to S1P receptor 1 and reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood and lymphocyte migration into the intestines. Decreases the cells involved in immune response.

           

Testing, Logistics, and Monitoring

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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

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.14

Use with caution in patients with chronic or recurrent infection.

METHOD OF ADMINISTRATION

IV infusion
SC injection

LOCATION
 

Infusion centre
Home

DOSING

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.

TIME REQUIRED

3-4 hrs
Those who do not experience a reaction can be infused <2 hrs

SC Injection – 5 min

ROUTINE MONITORING

Annual cervical cancer screening – pap test
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

           
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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

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.14

Use with caution in patients with chronic or recurrent infection.

METHOD OF ADMINISTRATION

SC injection

LOCATION
 

Home
Injection support can be arranged.

DOSING

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.

TIME REQUIRED

<15 min

ROUTINE MONITORING

Annual cervical cancer screening – pap test
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

           
Edit Content

PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

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.14

Use with caution in patients with chronic or recurrent infection.

METHOD OF ADMINISTRATION

IV infusion x 1 then SC injection

LOCATION

Infusion centre
Home

DOSING

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.

TIME REQUIRED

1–2 hrs for initial IV infusion
SC injection <15 min

ROUTINE MONITORING

Annual cervical cancer screening – pap test
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

           
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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

TB screening should be considered.

METHOD OF ADMINISTRATION

IV infusion or SC injection

LOCATION

Infusion centre or Home

DOSING

Induction: 300 mg IV wk 0, wk 2, wk 6,
then maintenance 300 mg 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.

TIME REQUIRED

1–2 hrs for infusion

< 5 min SC injection

ROUTINE MONITORING

Patients should be monitored for any new onset or worsening of neurological signs and symptoms

Liver enzymes – transaminases and bilirubin.
Annual cervical cancer screening – pap test
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

           
Edit Content

PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

Chest X-ray
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)

Ensure all immunizations are current.
Wait at least 4 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.14

Use with caution in patients with chronic or recurrent infection.

METHOD OF ADMINISTRATION

SC injection

LOCATION

Home

DOSING

Induction/loading: wk 0, two 100mg injections, wk 2, one 100 mg injection,
then maintenance, one 100 mg injection every 4 wks*

TIME REQUIRED

<15 min

ROUTINE MONITORING

Annual cervical cancer screening – pap test
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.

           
Edit Content

PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

TB skin test
Blood work (baseline CBC, liver enzymes, lipids, CK, renal function, hepatitis B serology)
Shingrix® zoster vaccination

Ensure all immunizations are current. Refer to CANIBD Vaccination Guidelines for further information.14

Recommend receiving live vaccines prior to starting therapy.

METHOD OF ADMINISTRATION

Oral

LOCATION

Home

DOSING

Induction/loading: 10 mg twice/day for 8 wks,

then maintenance 5 mg twice daily but 10 mg BID may also be used in some patients. Lowest possible dose should be used.

TIME REQUIRED

5 min

ROUTINE MONITORING

Lipids at baseline, 4–8 wks after initiation and every 6 mos thereafter.
Liver enzymes and renal function prior to initiation;
CBC with differential at baseline, approx. 4–8 wks after initiation, every 3 mos thereafter.
Annual cervical cancer screening – pap test
Annual skin exam – skin malignancies
Influenza vaccine recommended
Screening for osteoporosis with bone mineral density testing periodically after diagnosis

           
Edit Content

PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

TB skin test

Blood work (baseline CBC, liver enzymes, lipids, CK, renal function, Hepatitis B serology)

Shingrix® zoster vaccination

Recommend receiving live vaccines prior to starting therapy

METHOD OF ADMINISTRATION

Oral

LOCATION

Home

DOSING

Induction: 45mg once daily for 12 wks.
then maintenance 15mg or 30mg once daily.

TIME REQUIRED

5 mins 

ROUTINE MONITORING

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
Annual cervical cancer screening – pap test
Annual skin exam – skin malignancies
Influenza vaccine recommended
Screening for osteoporosis with bone mineral density testing periodically after diagnosis

           
Edit Content

PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

Baseline ECG

Ensure all immunizations are up to date. Refer to CANIBD Vaccination Guidelines for further information.14

Blood work (baseline LFTs and CBC)

Contraindications:

MAO inhibitors
Last 6 months: myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure, 2nd-degree AV block type II or 3rd-degree AV block, sick sinus syndrome or sinoatrial block unless patient has a pacemaker, pregnancy, severe infection, or active malignancies

METHOD OF ADMINISTRATION

Oral

LOCATION

Home

DOSING

Induction/loading:
Days 1–4: 0.23 mg
Day 5–7: 0.46 mg
Day 8 / Maintenance: 0.92 mg

TIME REQUIRED

5 mins

ROUTINE MONITORING

Before treatment initiation:  Baseline ECG, LFTs, CBC, VZV, negative pregnancy test

Only for patients at risk:  Ophthalmic evaluation, consult cardiologist, and 6-hr first dose observation

Patients should be monitored for any new onset of neurological or visual signs and symptoms and onset bradycardia.

LFTs and CBC

           
Edit Content

PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

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.14

METHOD OF ADMINISTRATION

Infusion/injection

LOCATION

Infusion centre
Home

DOSING

Induction: 300 mg IV wks 0, 4 and 8,

Evaluate patients after 12-week induction dosing and if there is adequate response transition to maintenance dosing.

If patients do not have adequate therapeutic response at week 12 after induction dosing, consider extended induction dosing by administering 300 mg IV at weeks 12, 16, and 20.

Maintenance:
200 mg SC (2 consecutive injections of 100 mg each) at wk 12 and every 4 wks thereafter.

TIME REQUIRED

Minimum 30-min infusion

Self-injection 5 min

ROUTINE MONITORING

Evaluate liver enzymes and bilirubin at baseline and every 1–4 mos during induction (including induction period, if applicable) and thereafter according to standard practice.
Annual cervical cancer screening – pap test
Annual skin exam – skin malignancies
Influenza vaccine recommended
Screening for osteoporosis with bone mineral density testing periodically after diagnosis