2 The technology

2 The technology

Description of the technology

Ustekinumab (Stelara, Janssen) is a human monoclonal antibody that acts as a cytokine inhibitor by targeting interleukin‑12 (IL‑12) and interleukin‑23 (IL‑23).

Marketing authorisation

Ustekinumab has a marketing authorisation in the UK for treating 'adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF‑alpha inhibitor or have medical contraindications to such therapies:

  • Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose may receive a second subcutaneous dose at this time.

  • Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks.

  • Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment'.

Adverse reactions

The most common adverse reactions for ustekinumab include arthralgia, headache, nausea, pyrexia, nasopharyngitis, abdominal pain, upper respiratory tract infection, diarrhoea and fatigue. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Ustekinumab is given as intravenous infusion at induction and as subcutaneous injection at maintenance:

  • 1 intravenous induction treatment (dose depends on body weight and is approximately 6 mg/kg).

  • Maintenance subcutaneous treatment at week 8 (90 mg), then every 12 weeks.

Price

The list price for ustekinumab is £2,147 per 130‑mg vial concentrate for solution for infusion and per 90‑mg vial solution for injection (excluding VAT; Monthly Index of Medical Specialties).

A confidential pricing arrangement has been agreed with the Commercial Medicines Unit.

  • National Institute for Health and Care Excellence (NICE)