Author: Anoma Ranaweera B.V. Sc; PhD (Clinical Biochemistry, University of Liverpool, UK), 2011. Reviewed and revised by Hon A/Prof Amanda Oakley, Dermatologist, Hamilton, New Zealand, September 2014.
Ustekinumab (brand name STELARA™) is a biological treatment used to treat moderate to severe psoriasis. It is a human monoclonal antibody that antagonises interleukin-12 (IL-12) and IL-23. Good to excellent responses are seen in more than two-thirds of patients with chronic plaque psoriasis treated with ustekinumab.
Ustekinumab has been shown in small studies to be useful in other forms of psoriasis, including nail psoriasis, erythrodermic psoriasis, generalised pustular psoriasis and palmoplantar pustulosis and blah. It is under investigation in the treatment of psoriatic arthritis and Crohn disease.
Psoriasis is caused by an increase in the production of T-cells and is influenced by cytokines, the chemical messengers produced by cells. Certain cytokines cause skin cells to grow rapidly, producing plaques of psoriasis. Ustekinumab is a monoclonal antibody that targets the p40 subunit of the cytokines IL-12 and IL-23, preventing them from binding and activating T-lymphocytes.
Ustekinumab is given by subcutaneous injection. The second dose is given 4 weeks after the first injection, and further doses are delivered every 12 weeks. It reaches its peak effect at around 28 weeks.
To date adverse infections are consistent with that seen with other biologics.
Immunisation status should be reviewed prior to starting ustekinumab. If necessary, vaccines should be updated prior to treatment with a biologic agent. Annual influenza vaccination is recommended.
As they may induce illness in immunodeficient individuals, live vaccines should not be used during treatment with ustekinumab. Currently available live attenuated viral vaccines include measles, mumps, rubella, varicella, yellow fever, influenza (intranasal vaccine) and oral polio vaccine. Live attenuated bacterial vaccines include BCG and oral typhoid vaccine.
There are no studies of ustekinumab in pregnant women. Ustekinumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Caution should be exercised when ustekinumab is administered to a nursing woman. The unknown risks to the infant from gastrointestinal or systemic exposure to ustekinumab should be weighed against the known benefits of breast-feeding.
Safety and effectiveness of ustekinumab in children have not been evaluated.
No pharmacokinetic data are available in patients with liver or kidney disease treated with ustekinumab.
It is recommended that patients on biologic medications have routine blood tests every 6 months or so, including full blood count and liver function tests. TB testing should be repeated from time to time.
For more detailed information about ustekinumab, refer to current Stelara® datasheet.
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