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Advanced Therapies in Crohn's Disease
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)
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 (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)
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/Enliven Services (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.
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.10
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.10
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
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.10
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
IV infusion x 1 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
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
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
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
May consider therapeutic drug monitoring (TDM) if available
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.
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:11
- 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.
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:11
- 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.
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.
Insufficient data to make a recommendation regarding safety in pregnancy.
As it is a monoclonal antibody, its safety profile is expected to be similar to that of other biologics, and it can be continued throughout pregnancy.12
Insufficient data regarding the safety in 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.
CHF: congestive heart failure, TNF: tumour necrosis factor, anti-TNFα: anti-tumour necrosis factor alpha, IBD: inflammatory bowel disease, hrs: hours, MMR: measles, mumps, rubella, BCG: Bacille Calmette-Guérin