Advanced Therapies in Crohn's Disease

Special Populations

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PAEDIATRICS

Approved for use in paediatric patients

ELDERLY

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).

PREGNANCY

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.

BREASTFEEDING

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.
           
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PAEDIATRICS

Approved for use in paediatric patients

ELDERLY

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).

PREGNANCY

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.

BREASTFEEDING

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.
           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

At present, there is not enough data to determine the safety in the elderly.

PREGNANCY

Not associated with an increased rate of adverse maternofetal outcomes, and it is reasonable to continue after discussing the potential risks with the patient.

BREASTFEEDING

Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

Clinical trials of vedolizumab did not include sufficient numbers of subjects aged 65+ to determine whether they respond differently from younger subjects.

PREGNANCY

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.

BREASTFEEDING

Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

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.

PREGNANCY

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

BREASTFEEDING

Insufficient data regarding the safety in breastfeeding.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

For patients older than 65 years of age, the recommended maintenance dose is 15mg once daily.

PREGNANCY

Contraindicated in use with pregnancy.

BREASTFEEDING

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

This tool is intended for Canadian Healthcare Professionals. Copyright © 2024 CANIBD Canadian IBD Nurses.

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CANIBD and Crohn's and Colitis Canada do not accept any responsibility or liability for the accuracy, content, completeness, legality, or reliability of the information contained in this Service. The content is not intended to diagnose, treat, cure or prevent disease. Content was developed in 2024 and is provided for informational purposes only.