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Advanced Therapies in Ulcerative Colitis
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.
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