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.
Indications: Plaque psoriasis; active psoriatic arthritis – can be used with or without methotrexate
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.
Adapted from: RheumaKnowledgy