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Anti-IL-12/23 Monoclonal Antibody Pregnancy: Preferably avoid in pregnancy as a precautionary measure (limited clinical experience). Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks afterwards.

Ustekinumab

Brand names: Stelara

Used in: Inflammatory Bowel Disease

A human monoclonal antibody biologic, administered by subcutaneous injection, used for moderate-to-severe plaque psoriasis (and psoriatic arthritis) in adults who have not responded to or cannot use conventional systemic therapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Plaque psoriasis (subcutaneous): 45 mg if 100 kg or less, or 90 mg if over 100 kg
Route: Subcutaneous
Frequency: Initially and 4 weeks later, then every 12 weeks
Dermatology (plaque psoriasis / psoriatic arthritis) subcutaneous dosing is taken from US labelling because the provided eMC bundle is the STELARA 130 mg IV concentrate, which covers only Crohn's disease / ulcerative colitis intravenous induction (no psoriasis posology) — verify against the UK subcutaneous-formulation SPC. Psoriatic arthritis: 45 mg initially and 4 weeks later then every 12 weeks (90 mg for patients with co-existent moderate-to-severe plaque psoriasis weighing over 100 kg). In patients over 100 kg, 45 mg was also efficacious but 90 mg gave greater efficacy. Elderly: no dose adjustment. Renal/hepatic impairment: not studied, no dose recommendations can be made.

Paediatric dose

Dose: 0.75 mg/kg
Route: subcutaneous
Frequency: Weeks 0 and 4, then every 12 weeks
Max: Children 60 kg or more use flat dosing: 45 mg (60-100 kg) or 90 mg (over 100 kg)
Plaque psoriasis / psoriatic arthritis, children aged 6 years and older weighing under 60 kg (US labelling — verify against UK SPC and a children's formulary).

Dose adjustments

Renal

Not studied in renal impairment; no dose recommendations can be made (eMC section 4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

Plaque psoriasis / psoriatic arthritis, children aged 6 years and older weighing under 60 kg (US labelling — verify against UK SPC and a children's formulary).

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Clinically important, active infection (e.g. active tuberculosis)

Side effects

  • Nasopharyngitis / upper respiratory tract infection
  • Headache
  • Dizziness
  • Diarrhoea, nausea, vomiting
  • Pruritus
  • Rare: serious hypersensitivity reactions including anaphylaxis and angioedema

Interactions

  • Avoid live vaccines during treatment (US label section 5.7)
  • CYP450 substrates with a narrow therapeutic index: monitor for therapeutic effect/drug concentration and adjust when starting or stopping ustekinumab (US label section 7.2)
  • Safety in combination with immunosuppressive agents or phototherapy not established (US label section 7.1)

Clinical monograph

How it works

Ustekinumab binds the shared p40 subunit of interleukin-12 and interleukin-23, preventing these cytokines from engaging their receptor and thereby down-regulating the Th1 and Th17 inflammatory pathways central to psoriatic plaque formation.

Prescribing in practice

  • As an immunosuppressant it increases infection risk, so active serious infection must be excluded and latent tuberculosis screened for and treated before starting, with patients advised to report signs of infection.
  • Live vaccines should be avoided during treatment, and immunisations brought up to date beforehand where possible.
  • It is a specialist-initiated biologic prescribed within defined disease-severity criteria, with caution in those with a history of malignancy.

Monitoring

Screen for tuberculosis, hepatitis and other infection before initiation and monitor clinically for infection and treatment response thereafter, in line with biologic protocols.

Counselling the patient

  • After loading doses, the injection is given as maintenance every few months; attend planned reviews.
  • Report fever, persistent cough or other signs of infection promptly.
  • Tell other clinicians you are on a biologic, and avoid live vaccines unless cleared by your specialist.

Evidence & guidelines

Ustekinumab is recommended by NICE for adults with severe plaque psoriasis meeting defined criteria, based on the PHOENIX trials demonstrating significant skin clearance versus placebo.

Reference: NICE TA340 (psoriasis); UNIFI Trial; BAD Biologics Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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