IBD Therapies Guide

Structured licensed dosing regimens from the ChatIBD dosing database.

Adalimumab

Anti-TNF: Neutralizes TNF-α to block pro-inflammatory signaling.

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	SC	160 mg at week 0, 80 mg at week 2
	Adult	Maintenance	SC	40 mg every 2 weeks starting at week 4Decreased response on 40 mg every other week: may increase to 40 mg every week or 80 mg every other week. Clinical response is usually achieved within 2-8 weeks; do not continue in patients failing to respond within this period (EMA SmPC 4.2).
Crohn's disease	Adult	Induction	SC	80 mg at week 0, 40 mg at week 2If a more rapid response is needed: 160 mg at week 0 and 80 mg at week 2, with awareness that the risk of adverse events is higher during induction (EMA SmPC 4.2).
	Adult	Maintenance	SC	40 mg every 2 weeks starting at week 4Decreased response on 40 mg every other week: may increase to 40 mg every week or 80 mg every other week. Patients not responding by week 4 may benefit from continued maintenance through week 12; reconsider continued therapy if no response by then (EMA SmPC 4.2).
Ulcerative colitis	Paediatric	Induction	SC	<40 kg: 80 mg at week 0 and 40 mg at week 2; ≥40 kg: 160 mg at week 0 and 80 mg at week 2
	Paediatric	Maintenance	SC	<40 kg: 40 mg every other week; ≥40 kg: 80 mg every other week; start at week 4Patients who turn 18 years of age while receiving this regimen should continue their prescribed maintenance dose. Guideline context: adolescents ≥40 kg may receive 40 mg every other week after 160 mg at week 0 and 80 mg at week 2; some patients require higher maintenance dosing. In smaller children, specialist BSA-based dosing and therapeutic drug monitoring may be considered.
Crohn's disease	Paediatric	Induction	SC	<40 kg: 40 mg at week 0 and 20 mg at week 2; ≥40 kg: 80 mg at week 0 and 40 mg at week 2For a more rapid response, with awareness of a potentially higher adverse-event risk: <40 kg, 80 mg at week 0 and 40 mg at week 2; ≥40 kg, 160 mg at week 0 and 80 mg at week 2.
	Paediatric	Maintenance	SC	<40 kg: 20 mg every other week; ≥40 kg: 40 mg every other week; start at week 4For insufficient response: <40 kg, 20 mg every week; ≥40 kg, 40 mg every week or 80 mg every other week.

Notes

Licensed for Crohn's disease and ulcerative colitis from 6 to 17 years of age.

Sources:EMA ESPGHAN UC 2025 ESPGHAN CD 2020

Azathioprine

Thiopurine: Interferes with purine synthesis to reduce lymphocyte proliferation and inflammation.

Database

Indication	Group	Phase	Route	Dose
Inflammatory bowel disease	Adult	Induction	—	Not used for induction.
	Adult	Maintenance	PO	2-2.5 mg/kg once daily
Inflammatory bowel disease	Paediatric	Induction	—	Not used for induction.
	Paediatric	Maintenance	PO	2-2.5 mg/kg once daily

Notes

Check TPMT and NUDT15.
Monitor FBC & LFTs: weeks 2, 4, 8, 12; then q3 months once stable.
Target 6-TGN: 235-450 pmol/8×10⁸ RBCs (↑ = myelotoxicity).
Target MMP: <5700 pmol/8×10⁸ RBCs (↑ = hepatotoxicity).
Low 6-TGN + Low/Normal MMP: suggests poor adherence/subtherapeutic; ↑ dose 25-33%, recheck in 4 weeks.
Low 6-TGN + High MMP (MMP:TGN >11): hypermethylator (↑TPMT activity); ↓ dose to 25-33% of original, add allopurinol 100 mg/day, recheck in 4 wks.

Sources:EMA BSG 2025 ESPGHAN UC 2025 ESPGHAN CD 2020

Beclometasone

corticosteroids

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	PO	5 mg once daily for 4 weeksSuggested when 5-ASA induction fails or is not tolerated and a more potent systemic corticosteroid is to be avoided.
	Adult	Maintenance	—	Beclometasone is not recommended for maintenance of remission.
Ulcerative colitis	Paediatric	Induction	PO	>30 kg: 5 mg once daily for 4 weeksThere is no evidence establishing whether or how to taper; abrupt discontinuation was used in trials and alternate-day tapering over 2-4 weeks may be considered.
	Paediatric	Maintenance	—	Beclometasone is not recommended for maintenance of remission.

Notes

A topically acting corticosteroid with high first-pass metabolism.

Sources:BSG 2025 ESPGHAN UC 2025

Budesonide

corticosteroids

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	PO · MMX colonic-release tablet	Budesonide MMX 9 mg once daily for 8 weeksSuggested when 5-ASA induction fails or is not tolerated and a more potent systemic corticosteroid is to be avoided.
	Adult	Maintenance	—	Budesonide MMX is not recommended for maintenance of ulcerative-colitis remission.
Crohn's disease	Adult	Induction	PO · ileal-release oral formulation	Budesonide 9 mg once daily for up to 8 weeksFor mild ileocaecal Crohn's disease; there is no evidence of benefit for more distal colonic inflammation.
	Adult	Maintenance	—	Budesonide is not recommended for maintenance of Crohn's-disease remission.
Microscopic colitis	Adult	Induction	PO	Oral budesonide 9 mg once daily for 6-8 weeksApplies to collagenous and lymphocytic colitis. The guideline does not identify a specific brand or formulation and does not prescribe a fixed taper.
	Adult	Maintenance	PO	6 mg once daily for 6 months, or 3 mg and 6 mg on alternate days for up to 12 monthsFor chronic active or recurrent disease, use the lowest effective dose for as long as needed and review withdrawal individually.
Ulcerative colitis	Paediatric	Induction	PO · MMX colonic-release tablet	>30 kg: budesonide MMX 9 mg once daily for 8 weeksThere is no evidence establishing whether or how to taper; abrupt discontinuation was used in trials and alternate-day tapering over 2-4 weeks may be considered.
	Paediatric	Maintenance	—	Budesonide MMX is not recommended for maintenance of paediatric ulcerative-colitis remission.
Crohn's disease	Paediatric	Induction	PO · ileal-release oral formulation	>40 kg: 9 mg once daily for 6 weeks, then 6 mg once daily for 2 weeks, then 3 mg once daily for 2 weeksFor mild ileocaecal Crohn's disease; there is no evidence of benefit for more distal colonic inflammation.
	Paediatric	Maintenance	—	Budesonide is not recommended for maintenance of paediatric Crohn's-disease remission.
Microscopic colitis	Paediatric	Induction	—	No paediatric microscopic-colitis regimen is established in the cited guideline.
	Paediatric	Maintenance	—	No paediatric microscopic-colitis maintenance regimen is established in the cited guideline.

Notes

For prolonged microscopic-colitis treatment, consider calcium/vitamin D and bone-mineral-density monitoring according to individual osteoporosis risk.
Do not substitute systemic prednisolone for budesonide in microscopic colitis.
Monitor for corticosteroid adverse effects and adrenal suppression, particularly after repeated or prolonged exposure.

Variants

Rectal budesonide for proctitis

Age 12 and above: enema once daily for 4 weeks; foam and suppository use is discussed in guidelines but is not supported by a paediatric dosing recommendation here.

Sources:BSG 2025 ESPGHAN UC 2025 ESPGHAN CD 2020 UEG/EMCG Microscopic Colitis 2020

Etrasimod

S1P receptor modulator: Traps lymphocytes in lymph nodes to reduce gut infiltration.

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	PO	2 mg once daily
	Adult	Maintenance	PO	2 mg once daily
Ulcerative colitis	Paediatric	Induction	PO	16-17 years: 2 mg once daily. Under 16 years: not established.Limited data in adolescents aged 16 and over: use with caution, especially when body weight is less than 40 kg, due to the potential for increased exposure (EMA SmPC 4.2).
	Paediatric	Maintenance	PO	16-17 years: 2 mg once daily. Under 16 years: not established.Limited data in adolescents aged 16 and over: use with caution, especially when body weight is less than 40 kg, due to the potential for increased exposure (EMA SmPC 4.2).

Notes

Obtain an ECG before treatment.
Caution with beta-blockers / QT-prolonging drugs
Monitor first dose in patients with resting HR <50 bpm, second-degree Mobitz I AV block, or a history of myocardial infarction/heart failure: Hourly pulse and blood pressure for at least 4 hours.
Monitor FBC and LFTs.
Contraindicated in pregnancy.
Licensed for moderately to severely active ulcerative colitis from 16 years of age (EMA SmPC 4.1). Safety and efficacy under 16 years have not been established.

Sources:EMA

Filgotinib

JAK inhibitor: Blocks Janus kinase signaling to reduce cytokine-driven immune activation.

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	PO	200 mg once daily for 10 weeks
	Maintenance	PO	200 mg once daily*

Notes

Induction may be extended up to 22 weeks.
Discontinue if no response by week 22.
Monitor FBC, LFTs, and lipids.
*100 mg once daily for maintenance in adults at higher risk of VTE, MACE and malignancy; may be escalated to 200 mg once daily in case of a flare (EMA SmPC 4.2).
*100 mg once daily for maintenance if age ≥65 years (induction stays 200 mg once daily), and at any phase if CrCl 15 to <60 mL/min. Not recommended if CrCl <15 mL/min (EMA SmPC 4.2).
Not recommended in patients ≥75 years.
Contraindicated in pregnancy.

Sources:EMA

Golimumab

Anti-TNF: Neutralizes TNF-α to block pro-inflammatory signaling.

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	SC	200 mg at week 0, 100 mg at week 2
	Adult	Maintenance	SC	50 mg every 4 weeks if <80 kg beginning at week 6; 100 mg every 4 weeks if ≥80 kg
Ulcerative colitis	Paediatric	Induction	SC	≥15 to <40 kg: 100 mg at week 0 and 50 mg at week 2. ≥40 kg: 200 mg at week 0 and 100 mg at week 2.
	Paediatric	Maintenance	SC	Starting at week 6. ≥15 to <40 kg: 50 mg every 4 weeks. ≥40 kg (including ≥80 kg): 100 mg every 4 weeks.Optional reduction for patients in remission at or after week 54: ≥15 to <40 kg, 25 mg every 4 weeks; ≥40 to <80 kg, 50 mg every 4 weeks; ≥80 kg, not applicable. Clinical response is usually achieved within 12 to 14 weeks (after 4 doses); reconsider continued therapy in children with no evidence of benefit within this period. The 50 mg pre-filled pen has not been studied in paediatric UC and is not recommended (EMA SmPC 4.2).

Notes

Consider discontinuation if no evidence of benefit by week 14.
Licensed for moderately to severely active ulcerative colitis from 2 years of age with a body weight of at least 15 kg, after inadequate response to, or intolerance of, conventional therapy including corticosteroids and 6-MP or azathioprine (EMA SmPC 4.1). Not licensed for paediatric Crohn's disease.

Sources:EMA

Guselkumab

Anti-IL23: Selectively blocks IL-23 to limit Th17-mediated inflammation.

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	IV	200 mg at weeks 0, 4, and 8
	Induction	SC	400 mg (2 × 200 mg) at weeks 0, 4, and 8
	Maintenance	SC	100 mg every 8 weeks from week 16 or 200mg every 4 weeks from week 12
Crohn's disease	Induction	IV	200 mg at weeks 0, 4, and 8
	Induction	SC	400 mg at weeks 0, 4, and 8
	Maintenance	SC	100 mg every 8 weeks from week 16 or 200mg every 4 weeks from week 12

Notes

Consider discontinuation if no evidence of benefit by week 24.
Monitor LFTs.

Sources:EMA

Hydrocortisone

corticosteroids

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	IV · systemic intravenous corticosteroid	100 mg every 6 hours for acute severe ulcerative colitis
	Maintenance	—	Intravenous corticosteroids are not maintenance therapy.

Notes

Assess response by day 3 and consider rescue therapy or surgery if not responding.

Sources:BSG 2025

Infliximab

Anti-TNF: Neutralizes TNF-α to block pro-inflammatory signaling.

Database

Indication	Group	Phase	Route	Dose
Inflammatory bowel disease	Adult	Induction	IV	5 mg/kg at weeks 0, 2, and 6
	Adult	Maintenance	IV	5 mg/kg every 8 weeks starting at week 14
	Adult	Maintenance	SC	120 mg every 2 weeks, starting 4 weeks after the last IV infusionBefore switching to SC: 2 IV infusions of 5 mg/kg 2 weeks apart (weeks 0 and 2), with an optional third 5 mg/kg infusion 4 weeks after the second (week 6). The first SC dose is therefore at week 6, or at week 10 after the optional third infusion (EMA SmPC 4.2). SC loading applies to rheumatoid arthritis only.
Ulcerative colitis	Paediatric	Induction	IV	5 mg/kg at weeks 0, 2, and 6
	Paediatric	Maintenance	IV	5 mg/kg every 8 weeksGuideline context: 5-10 mg/kg every 4-8 weeks; patients may initially require approximately 10 mg/kg every 4-8 weeks, with subsequent adjustment guided by therapeutic drug monitoring.
Crohn's disease	Paediatric	Induction	IV	5 mg/kg at weeks 0, 2, and 6
	Paediatric	Maintenance	IV	5 mg/kg every 8 weeksGuideline context: consider dose and/or interval intensification according to disease activity, increased clearance and therapeutic drug monitoring.

Notes

Therapeutic drug monitoring may alter dosage/intervals.
Consider combination therapy with immunomodulator such as azathioprine (clinical trial data/guideline recommendation).
Specifically licensed for fistulising Crohn's disease.
Licensed for Crohn's disease and ulcerative colitis from 6 to 17 years of age; no paediatric posology can be recommended below age 6.

Variants

Acute Severe Colitis

Accelerated induction (3 doses within 24 days, for example at week 0, 1 and 2) with 5-10 mg/kg. [BSG 2025; Low-Quality Evidence]

Sources:EMA BSG 2025 ESPGHAN UC 2025 ESPGHAN CD 2020

Mercaptopurine

Thiopurine: Interferes with purine synthesis to reduce lymphocyte proliferation and inflammation.

Database

Indication	Group	Phase	Route	Dose
Inflammatory bowel disease	Adult	Induction	—	Not used for induction.
	Adult	Maintenance	PO	1-1.5 mg/kg once daily
Inflammatory bowel disease	Paediatric	Induction	—	Not used for induction.
	Paediatric	Maintenance	PO	1-1.5 mg/kg/day (max 75 mg once daily)

Notes

Check TPMT and NUDT15.
Monitor FBC & LFTs: weeks 2, 4, 8, 12; then q3 months once stable.
Target 6-TGN: 235-450 pmol/8×10⁸ RBCs (↑ = myelotoxicity).
Target MMP: <5700 pmol/8×10⁸ RBCs (↑ = hepatotoxicity).
Low 6-TGN + Low/Normal MMP: suggests poor adherence/subtherapeutic; ↑ dose 25-33%, recheck in 4 weeks.
Low 6-TGN + High MMP (MMP:TGN >11): hypermethylator (↑TPMT activity); ↓ dose to 25-33% of original, add allopurinol 100 mg/day, recheck in 4 wks.

Sources:EMA BSG 2025 ESPGHAN UC 2025 ESPGHAN CD 2020

Mesalazine

5-Aminosalicylic Acid: Acts locally in the gut to reduce inflammation via COX and NF-κB inhibition.

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	PO	≥2 g/day up to 4.8 g/day
	Adult	Induction	PR	≥1 g/day
	Adult	Maintenance	PO	≥2 g/day
	Adult	Maintenance	PR	≥1 g/day
Ulcerative colitis	Paediatric	Induction	PO	60-80 mg/kg/day (max 4.8 g/day)
	Paediatric	Induction	PR	25 mg/kg up to 1 g/day
	Paediatric	Maintenance	PO	60-80 mg/kg/day (max 4.8 g/day)
	Paediatric	Maintenance	PR	25 mg/kg up to 1 g/day

Notes

Mesalazine not recommended for Crohn's disease.
Topical therapy (suppositories/enemas) can be used for proctitis or left-sided colitis.

Sources:EMA

Methotrexate

Antimetabolite: Inhibits nucleotide synthesis to limit immune cell proliferation.

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	—	No licensed ulcerative colitis dose; methotrexate monotherapy is not recommended for induction.
	Adult	Maintenance	—	No licensed ulcerative colitis dose; methotrexate monotherapy is not recommended for maintenance of remission.
Crohn's disease	Adult	Induction	SC	25 mg once weekly
	Adult	Maintenance	SC	15 mg once weekly
Ulcerative colitis	Paediatric	Induction	—	Methotrexate is not recommended for paediatric ulcerative colitis.
	Paediatric	Maintenance	—	Methotrexate is not recommended for paediatric ulcerative colitis.
Crohn's disease	Paediatric	Induction	SC	15 mg/m² once weekly (max 25 mg)
	Paediatric	Maintenance	SC	15 mg/m² once weekly (max 25 mg)

Notes

Rarely used for induction alone.
Monitor FBC, U&E and LFTs every 1-2 weeks until stable, thereafter every 2-3 months.
Be aware of significant side effects including marrow suppression, GI/liver/lung toxicity.
Consider folic acid supplementation to reduce side effects.
Contraindicated in pregnancy.
EMA Alert: Ensure patients remember dosing is once a week only. Serious side effects and fatalities have occurred due to accidental overdosing.
Ages 7 and above only.

Sources:BSG 2025

Methylprednisolone

corticosteroids

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	IV · systemic intravenous corticosteroid	30 mg every 12 hours for acute severe ulcerative colitis
	Maintenance	—	Intravenous corticosteroids are not maintenance therapy.

Notes

Assess response by day 3 and consider rescue therapy or surgery if not responding.

Sources:BSG 2025

Mirikizumab

Anti-IL23: Selectively blocks IL-23 to limit Th17-mediated inflammation.

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	IV	300 mg at weeks 0, 4, and 8*
	Maintenance	SC	200 mg every 4 weeks
Crohn's disease	Induction	IV	900 mg at weeks 0, 4, and 8
	Maintenance	SC	300 mg every 4 weeks

Notes

*For ulcerative colitis, extended induction can be considered with 300mg IV at weeks 12, 16 and 20.
Consider discontinuation if no evidence of benefit by week 24.
Monitor LFTs.

Sources:EMA

Ozanimod

S1P receptor modulator: Traps lymphocytes in lymph nodes to reduce gut infiltration.

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	PO	Days 1-4: 0.23 mg once daily; Days 5-7: 0.46 mg once daily; Thereafter: 0.92 mg once daily
	Maintenance	PO	0.92 mg once daily

Notes

Obtain an ECG before treatment.
Caution with beta-blockers / QT-prolonging drugs
Monitor first dose in patients with resting HR <55 bpm, second-degree Mobitz I AV block, or a history of myocardial infarction/heart failure: Hourly pulse and blood pressure for at least 6 hours + ECG at 0 and 6 hours.
Monitor FBC and LFTs.
Advise sun protection to reduce risk of non-melanoma skin cancers.
Contraindicated in pregnancy.

Sources:EMA

Prednisolone

corticosteroids

Database

Indication	Group	Phase	Route	Dose
Ulcerative colitis	Adult	Induction	PO · systemic oral corticosteroid	40 mg once daily, reducing by 5 mg each week to 0 mg
	Adult	Maintenance	—	Corticosteroids are not recommended for maintenance of remission.
Crohn's disease	Adult	Induction	PO · systemic oral corticosteroid	40 mg once daily, tapering over 8 weeks
	Adult	Maintenance	—	Corticosteroids are not recommended for maintenance of remission.
Microscopic colitis	Adult	Induction	—	The European microscopic-colitis guideline recommends against prednisolone or corticosteroids other than budesonide.
	Adult	Maintenance	—	Prednisolone is not recommended for microscopic-colitis maintenance.
Ulcerative colitis	Paediatric	Induction	PO · systemic oral corticosteroid	1 mg/kg (maximum 40 mg) once daily in the morning for 1-2 weeks, then taper over up to 7 weeks
	Paediatric	Maintenance	—	Corticosteroids are not recommended for maintenance of remission.
Crohn's disease	Paediatric	Induction	PO · systemic oral corticosteroid	1 mg/kg (maximum 40 mg) once daily, tapering after remission and no later than 4 weeks after initiation
	Paediatric	Maintenance	—	Corticosteroids are not recommended for maintenance of remission.
Microscopic colitis	Paediatric	Induction	—	No paediatric prednisolone regimen is recorded for microscopic colitis.
	Paediatric	Maintenance	—	No paediatric prednisolone maintenance regimen is recorded for microscopic colitis.

Notes

Consider adding bone protection (calcium/vitamin D).
Consider DEXA scan if on steroids >3 months.

Variants

Rectal prednisolone for proctitis

Age 2 and above: suppositories 5 mg twice daily. Age 12 and above: foam 20-40 mg once daily for 2 weeks initially and up to 4 weeks.

Sources:BSG 2025 ESPGHAN UC 2025 ESPGHAN CD 2020 UEG/EMCG Microscopic Colitis 2020

Risankizumab

Anti-IL23: Selectively blocks IL-23 to limit Th17-mediated inflammation.

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	IV	1200 mg at weeks 0, 4, and 8
	Maintenance	SC	180 mg or 360 mg every 8 weeks from week 12
Crohn's disease	Induction	IV	600 mg at weeks 0, 4, and 8
	Maintenance	SC	360 mg every 8 weeks from week 12EMA label: 360 mg is the only licensed Crohn's maintenance dose. The US (FDA) label also permits 180 mg every 8 weeks; 180 mg is not an EU-licensed Crohn's option.

Notes

Consider discontinuation if no evidence of benefit by week 24.
Monitor LFTs.

Sources:EMA

Tofacitinib

JAK inhibitor: Blocks Janus kinase signaling to reduce cytokine-driven immune activation.

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	PO	10 mg twice daily for 8 weeks
	Maintenance	PO	5 mg twice daily*

Notes

Monitor FBC, LFTs, and lipids.
Induction may be extended to 16 weeks if response at week 8 is inadequate.
Discontinue if no response by week 16.
*10 mg orally twice daily may be considered if response decreases on 5 mg twice daily
*10 mg twice daily for maintenance treatment is not recommended in patients with known venous thromboembolism, major adverse cardiovascular events and malignancy risk factors, unless there is no suitable alternative treatment available.
*10 mg twice daily for maintenance should be used for the shortest duration possible.
Contraindicated in pregnancy.

Sources:EMA

Upadacitinib

JAK inhibitor: Blocks Janus kinase signaling to reduce cytokine-driven immune activation.

Database

Indication	Phase	Route	Dose
Ulcerative colitis	Induction	PO	45 mg once daily for 8 weeks*
	Maintenance	PO	15-30 mg once daily #
Crohn's disease	Induction	PO	45 mg once daily for 12 weeks**
	Maintenance	PO	15-30 mg once daily #

Notes

*Ulcerative colitis: Prolonged induction up to further 8 weeks. Discontinue if no response by week 16.
**Crohn's disease: Prolonged induction at 30 mg once daily up to further 12 weeks. Discontinue if no response by week 24.
# Maintenance: 15 mg once daily is recommended for patients at higher risk of VTE, MACE and malignancy, and for patients aged ≥65. 30 mg once daily may be appropriate for patients not at higher risk with high disease burden (UC: or requiring 16-week induction), or with inadequate benefit on 15 mg (EMA SmPC 4.2).
Monitor FBC, LFTs, and lipids.
Caution in venous thromboembolism, cardiovascular disease, and malignancy risk factors.
Contraindicated in pregnancy.

Sources:EMA

Ustekinumab

Anti-IL12/23: Inhibits shared p40 subunit to reduce Th1 and Th17 immune responses.

Database

Indication	Group	Phase	Route	Dose
Inflammatory bowel disease	Adult	Induction	IV	≤55 kg: 260 mg; >55 to ≤85 kg: 390 mg; >85 kg: 520 mgSingle IV dose based on body weight at the time of dosing; approximately 6 mg/kg (EMA SmPC 4.2, Table 1).
	Adult	Maintenance	SC	90 mg every 8-12 weeks starting at week 8
Ulcerative colitis	Paediatric	Induction	—	Not established: the safety and efficacy of ustekinumab in ulcerative colitis in paediatric patients less than 18 years have not yet been established, and no data are available (EMA SmPC 4.2). Adult licence only.
	Paediatric	Maintenance	—	Not established: the safety and efficacy of ustekinumab in ulcerative colitis in paediatric patients less than 18 years have not yet been established, and no data are available (EMA SmPC 4.2). Adult licence only.
Crohn's disease	Paediatric	Induction	IV	Single IV dose. <40 kg (BSA-based): BSA 0.40 to <0.62 m²: 130 mg; 0.62 to <0.95 m²: 200 mg; 0.95 to <1.25 m²: 260 mg; ≥1.25 m²: 325 mg. ≥40 kg (weight-based): ≥40 to ≤55 kg: 260 mg; >55 to ≤85 kg: 390 mg; >85 kg: 520 mg (approximately 6 mg/kg).BSA or body weight at the time of dosing. <40 kg infusion volumes (EMA SmPC 4.2, Table 2): 26 mL (1 × 130 mg vial), 40 mL (2 vials), 52 mL (2 vials), 65 mL (3 vials) for the four BSA bands in order. Give over at least one hour.
	Paediatric	Maintenance	SC	First SC dose at week 8 after the IV dose, then every 12 weeks. <40 kg (BSA-based): BSA 0.40 to <0.62 m²: 36 mg (0.4 mL); 0.62 to <0.95 m²: 45 mg (0.5 mL); 0.95 to <1.25 m²: 63 mg (0.7 mL); ≥1.25 m²: 90 mg (1.0 mL). ≥40 kg: 90 mg.<40 kg volumes are from the 45 mg/0.5 mL vial (EMA SmPC 4.2, Table 3): round the calculated volume to the nearest 0.1 mL and give with a 1 mL graduated syringe; the pre-filled syringe may be used instead of the vial for the 45 mg and 90 mg doses. Loss of response on every-12-week dosing: frequency may be increased to every 8 weeks, then every 8 or 12 weeks according to clinical judgment. Loss of response on every 12 or 8 weeks with low ustekinumab trough (<1.4 μg/mL by a validated assay): the interval may be shortened to every 4 weeks if clinically indicated; repeat the trough 12 or 16 weeks after the change; if the trough is >7.2 μg/mL and response is maintained, the interval may be changed to every 8 weeks. Consider discontinuing if there is no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after dose adjustment.

Notes

Dosing frequency may be increased to every 8 weeks based on clinical response.
Consider discontinuation if no evidence of benefit by week 16.
Licensed for moderately to severely active Crohn's disease in paediatric patients from the age of 2 years who have had an inadequate response to, or were intolerant to, either conventional or biologic therapy (EMA SmPC 4.1).
Safety and efficacy in Crohn's disease in paediatric patients less than 2 years and less than 10 kg have not been established; no data are available.
<40 kg: both the IV induction dose and the SC maintenance dose are BSA-based (four BSA bands); the flat 90 mg SC maintenance dose applies from 40 kg.
The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients (EMA SmPC 4.2); use the vial or pre-filled syringe.
These paediatric doses follow the EMA (EU) label. UK (MHRA) licensing may differ for patients under 40 kg; check the current UK SmPC (emc) before applying BSA-based dosing in the UK.

Sources:EMA

Vedolizumab

Anti-integrin: Blocks leukocyte adhesion and trafficking into gut tissue.

Database

Indication	Phase	Route	Dose
Inflammatory bowel disease	Induction	IV	300 mg at weeks 0, 2, and 6
	Maintenance	IV	300 mg every 8 weeks
	Maintenance	SC	108 mg every 2 weeks

Notes

For Crohn's disease, optional 300 mg IV at week 10 if no response by week 6.

Variants

Pouchitis

Vedolizumab is licensed for the treatment of pouchitis in patients with inadequate response to antibiotic therapy. The induction and maintenance regimen is the same as above. Treatment should be started in parallel with antibiotics, and discontinued if there is no clinical response by week 14.

Sources:EMA