Last updated: October 24, 2014
Trade Names: Stelara
Drug Class: IL-12 and IL-23 inhibitor
Preparations: Subcutaneous injection: 45 mg/0.5 mL and 90 mg/mL (1 mL), both available as vials and prefilled syringes
Dose: Adults with psoriatic arthritis: 45 mg by subcutaneous injection at weeks 0 and 4 and then every 12 weeks thereafter; for adults with plaque psoriasis who weigh less than 100 kg – same dose as for psoriatic arthritis; for those weighing more than 100 kg – 90 mg at weeks 0 and 4 and then every 12 weeks thereafter.
Mechanism of Action: Human monoclonal antibody binds to the p40 subunit of IL-12 and IL-23 interfering with cytokine signalling
Contraindications: Hypersensitivity, active infection, avoid live virus vaccines, avoid BCG for 1 year before, during, and 1 year following treatment
Precautions: Increased risk of serious infections including TB and fungal. Exclude latent or active TB with a skin test or TB blood test (interferon-gamma release assays or IGRA). Caution in debilitated or high risk of infection.
Monitoring: After therapy started, additional TB testing may be indicated for individuals likely to have exposure to TB. Monitor for skin cancer.
Pregnancy Risk: B
Common: Minor infections, injection site reactions, headache, upper respiratory tract infections
Less common: Allergy, rash, serious infection (bacterial, viral and also atypical and opportunistic infections), antibodies to ustekinumab
Rare: Anaphylaxis, reversible posterior leukoencephalopathy syndrome, malignancy particularly skin cancer, pustular psoriasis
Live virus vaccines and BCG: Avoid
Other biologics and potent immunosuppressants: Avoid, increased risk of infection
Patient Instructions: Avoid live virus vaccines. Stop injections if have an infection. May increase risk of skin cancer.
Comments: In psoriasis trials PASI score decreased approximately 70% vs. 4% on placebo. In psoriatic arthritis trials ACR20 responses occurred with ustekinumab 45 mg in approximately 43% vs 22% on placebo. Psoriatic arthritis placebo-controlled trials are difficult to blind because associated psoriasis is very responsive to ustekinumab. Individuals genetically deficient in IL12/IL23 have increased risks of disseminated mycobacterial, BCG and salmonella infections; infection risks from ustekinumab are not well characterized. Limited information on other long-term risks (e.g. malignancy, cardiovascular).
Clinical Pharmacology: Half-life is 10-126 days. Biologic agents are not metabolized and have few drug interactions.
McInnes IB, Kavanaugh A, Gottlieb AB, et al Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet 2013;382:780-9.PMID: 23769296.