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
NEW GLOBAL
GUIDELINES

For access to the full guidelines click here

The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend: 17

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.17

BREASTFEEDING

The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend: 17

Mothers with IBD currently on anti-TNF agents may breastfeed.

Please refer to the original publication for additional information. 17
           
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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
NEW GLOBAL
GUIDELINES

For access to the full guidelines click here

The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend: 17

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.17

BREASTFEEDING

The authors of the 2025 Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease recommend: 17

Mothers with IBD currently on anti-TNF agents may breastfeed.

Please refer to the original publication for additional information. 17
           
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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
NEW GLOBAL
GUIDELINES

For access to the full guidelines click here

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.17

BREASTFEEDING

Mothers with IBD currently on anti-IL 12/23 and anti-IL23 agents may breastfeed.17
           
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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
NEW GLOBAL
GUIDELINES

For access to the full guidelines click here

In women with inflammatory bowel disease who are pregnant or attempting conception, we suggest continuing maintenance vedolizumab therapy throughout pregnancy.17

BREASTFEEDING

Mothers with IBD currently on anti-integrins may breastfeed.17    

           
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PAEDIATRICS

Not currently approved for paediatric use.

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: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.

BREASTFEEDING

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.
           
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PAEDIATRICS

Not currently approved for paediatric use.

ELDERLY

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.

PREGNANCY

Contraindicated in use with pregnancy.

BREASTFEEDING

Contraindicated in use with 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
NEW GLOBAL
GUIDELINES

For access to the full guidelines click here

Women with IBD should discontinue upadacitinib at least 4 weeks prior to conception unless there is no effective alternative therapy to maintain maternal health. 17

BREASTFEEDING

Mothers with IBD currently on JAKi should not breastfeed.17    
           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

Not currently approved for maintenance in people who are 65 years old or older.

PREGNANCY

Contraindicated in use with pregnancy.

Women of childbearing potential should stop ozanimod 3 months prior to conception.

BREASTFEEDING

Contraindicated in use with breastfeeding.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

Geriatrics: limited data.  Population pharmacokinetic analysis showed no overall differences in mirikizumab exposure between older and younger subjects.

PREGNANCY

Safety in pregnancy has not been determined.

BREASTFEEDING

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.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

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.

PREGNANCY

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.

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