Advanced Therapies in Ulcerative Colitis
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)
Crohn’s disease
Ulcerative colitis
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/Enliven Services (2021)
Hadlima®/Organon/Harmony by Organon™ (2021)
Hulio®/Biocon/My Biocon Biologics (2022)
Idacio®/Fresenius Kabi/KabiCare® (2021)
Simlandi™/JAMP Pharma/JAMP Care (2022)
Yuflyma®/Celltrion/Celltrion Connect™ (2022)
Crohn’s disease
Ulcerative colitis
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®/Janssen/BioAdvance® (CD 2017, UC 2020)
Wezlana™/Amgen/EnlivenServices (2024)
Crohn’s disease
Ulcerative colitis
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.
Crohn’s disease
Ulcerative colitis
Monoclonal antibody integrin receptor blocker
Simponi®/Janssen/BioAdvance® (2013)
Ulcerative colitis
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.
Xeljanz®/Pfizer/PfizerFlex™ (2018)
Ulcerative colitis
Janus kinase (JAK) inhibitor
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.
Rinvoq/Abbvie/Abbvie Care (2023)
Crohn’s disease
Ulcerative colitis
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.
Zeposia®/Bristol Myers Squibb/Bristol Myers Squibb Access Support® (2022)
Ulcerative colitis
Sphingosine 1 phosphate (S1P) modulator
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.
Ulcerative colitis
Interleukin-23 (IL-23) p 19 antagonist
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.
Ulcerative colitis
Selective Sphingosine 1-phosphate (S1P) receptor modulator
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.
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.
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
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
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.
SC injection
Home
Injection support can be arranged.
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
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
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.
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
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
TB screening should be considered.
IV infusion or SC injection
Infusion centre or Home
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.
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.
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
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.
SC injection
Home
Induction/loading: wk 0, two 100mg injections, wk 2, one 100 mg injection,
then maintenance, one 100 mg injection every 4 wks*
<15 min
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.
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.
Oral
Home
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.
5 min
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
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
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
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
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
Oral
Home
Induction/loading:
Days 1–4: 0.23 mg
Day 5–7: 0.46 mg
Day 8 / Maintenance: 0.92 mg
5 mins
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
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
Infusion centre
Home
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.
Minimum 30-min infusion
Self-injection 5 min
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
For more detailed information on vaccinations, please see the CANIBD Vaccination Guide
Baseline ECG
In patients with pre-existing conditions, advice from a cardiologist should be sought.
Blood work (baseline CBC, renal and liver function)
Opthalmic assessment in patients with a history of diabetes, uveitis or retinal disease.
Ensure all immunizations are current. Refer to CANIBD Vaccination Guidelines for further information14
Contraindications:
Last 6 months: myocardial infarction, unstable angina, pectoris, stroke, transient ischemic attack, decompensated heart failure, Mobitz type II second-degree or third-degree atrioventricular block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker, immunocompromised, severe active infections, active malignancies
Oral
Home
Induction/loading: 2 mg tablet once daily
Due to risk of transient decreases in heart rate, first dose cardiac monitoring recommended if there has been abnormality on baseline ECG.
Please refer to product monograph.
5 min
Baseline bloodwork: Liver enzymes, ECG and ophthalmic evaluation. Follow up blood work as clinically indicated.
Blood pressure should be monitored during treatment and managed appropriately.
Patients with a history of diabetes mellitus, uveitis or retinal disease undergo follow up ophthalmologic evaluations while receiving therapy.
*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, wk: week, hr: hour, SC: subcutaneous, min: minutes, CK: creatine kinase, , mos: months, q: every, ECG: electrocardiogram, LFT: liver function test, MAO: monoamine oxidase, TIA: transient ischemic attack, AV: atrioventricular, VZV: varicella zoster virus.
wk: week, TB: tuberculosis, CHF: coronary heart failure, TNF: Anti-tumour necrosis factor, ¬HBV: hepatitis B virus, NMSC: non-melanoma skin cancer, GI: gastrointestinal, CPK: creatine phosphokinase, HR: heart rate, ALT: alanine transaminase, BP: blood pressure.
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 2023 Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breastfeeding recommend:15
- Anti-TNF-α agents can be initiated or continued throughout pregnancy.
- Anti-TNF-α agents can be continued uninterrupted throughout the third trimester, with premature cessation being associated with an increased risk of disease flare.
- Anti-TNF therapy can be resumed 24 hrs after an uncomplicated vaginal delivery and 48 hrs after an uncomplicated Caesarean delivery if it was ceased or altered during gestation.
- Live vaccines (including MMR, BCG, and rotavirus) should be avoided for 12 months if the neonate was exposed to a biological agent in utero. Non-live vaccines should be given on schedule.
The authors of the 2023 Australian inflammatory bowel disease consensus statement for preconception, pregnancy, and breastfeeding recommend:15
- Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.
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 2023 Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breastfeeding recommend:15
- Anti-TNF-α agents can be initiated or continued throughout pregnancy.
- Anti-TNF-α agents can be continued uninterrupted throughout the third trimester, with premature cessation being associated with an increased risk of disease flare.
- Anti-TNF therapy can be resumed 24 hrs after an uncomplicated vaginal delivery and 48 hrs after an uncomplicated Caesarean delivery if it was ceased or altered during gestation.
- Live vaccines (including MMR, BCG, and rotavirus) should be avoided for 12 months if the neonate was exposed to a biological agent in utero. Non-live vaccines should be given on schedule.
The authors of the 2023 Australian inflammatory bowel disease consensus statement for preconception, pregnancy, and breastfeeding recommend:11
- Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.
Not currently approved for paediatric use
At present, there is not enough data to determine the safety in the elderly.
Not associated with an increased rate of adverse maternofetal outcomes, and it is reasonable to continue after discussing the potential risks with the patient.
Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.
Clinical trials of vedolizumab did not include sufficient numbers of subjects aged 65+ to determine whether they respond differently from younger subjects.
Does not appear to be associated with an increased rate of adverse maternofetal outcomes, and it may be continued after discussing the potential risks with the patient.
Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.
Not currently approved for paediatric use.
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 2023 Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breastfeeding recommend:15
- Anti-TNF-α agents can be initiated or continued throughout pregnancy.
- Anti-TNF-α agents can be continued uninterrupted throughout the third trimester, with premature cessation being associated with an increased risk of disease flare.
- Anti-TNF therapy can be resumed 24 hrs after an uncomplicated vaginal delivery and 48 hrs after an uncomplicated Caesarean delivery if it was ceased or altered during gestation.
- Live vaccines (including MMR, BCG, and rotavirus) should be avoided for 12 months if the neonate was exposed to a biological agent in utero. Non-live vaccines should be given on schedule.
The authors of the 2023 Australian inflammatory bowel disease consensus statement for preconception, pregnancy, and breastfeeding recommend:15
- Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.
Not currently approved for paediatric use.
The frequency of serious infection among Xeljanz-treated subjects 65 years of age and older was higher than among those younger than age 65.
Safety has not been determined.
Use with caution in the elderly.
Contraindicated in use with pregnancy.
Contraindicated in use with breastfeeding.
Not currently approved for paediatric use
For patients older than 65 years of age, the recommended maintenance dose is 15mg once daily.
Contraindicated in use with pregnancy.
Contraindicated in use with breastfeeding.
Not currently approved for paediatric use
Not currently approved for maintenance in people who are 65 years old or older.
Contraindicated in use with pregnancy.
Women of childbearing potential should stop ozanimod 3 months prior to conception.
Contraindicated in use with breastfeeding.
Not currently approved for paediatric use
Geriatrics: limited data. Population pharmacokinetic analysis showed no overall differences in mirikizumab exposure between older and younger subjects.
Safety in pregnancy has not been determined.
Safety in breastfeeding has not been determined.
There is no data on presence of mirikizumab in human milk. Caution should be exercised in use with breastfeeding women.
Not currently approved for paediatric use
Limited data available on patients aged 65 years and older. Use in elderly should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. No dose adjustments needed in patients aged 65 years and older.
Contraindicated in use with pregnancy. Women of childbearing potential should be counseled on the need for effective contraception during treatment and for 6 days after stopping.
Contraindicated in use with breastfeeding.