Ustekinumab (Stelara): Uses, MOA, and Safety

What is ustekinumab?

Ustekinumab is an active ingredient used in some prescription medicines for inflammatory conditions. It is known in the United States by the brand name Stelara.

It is used in adults for certain forms of psoriasis, psoriatic arthritis, and Crohn’s disease. It is also used in adolescents with moderate to severe plaque psoriasis in some cases.

How ustekinumab works

Ustekinumab works by inhibiting the activity of the cytokines IL-12 and IL-23 by preventing them from binding to the receptor protein IL-12Rβ1 on immune cells.

This action is believed to interrupt signalling pathways and cytokine cascades involved in psoriatic disease.

What ustekinumab is used for

Based on the source content, ustekinumab is used for the following indications:

• Moderate to severe plaque psoriasis in adults who do not respond to, cannot use, or do not tolerate other systemic treatments, including cyclosporine, methotrexate, or PUVA.
• Moderate to severe plaque psoriasis in adolescents aged 12 years and older when other systemic therapies or phototherapies have not worked well enough or are not tolerated.
• Active psoriatic arthritis in adults, alone or with methotrexate, when previous non-biological DMARD treatment has been inadequate.
• Moderate to severe active Crohn’s disease in adults when conventional treatment or TNF-alpha antagonists have not worked, are not tolerated, or are contraindicated.

Dosage information at a glance

The exact dose depends on the condition, age, and body weight. The details below reflect the source content and should always be checked against the official prescribing information.

For children under 60 kg, the source content also describes a weight-based injection volume calculation. Because this is a technical dosing detail, it should be verified in the official leaflet or by a healthcare professional before use.

How it is given

Intravenous infusion

The 130 mg concentrate for solution for infusion is given only intravenously and must be administered for at least one hour.

Subcutaneous injection

The 45 mg and 90 mg injectable solutions are given by subcutaneous injection. When possible, areas of skin affected by psoriasis should be avoided as injection sites.

Some patients may be taught to inject themselves if a clinician considers it appropriate.

Who should not use ustekinumab

The source content lists the following contraindications:

• Hypersensitivity to ustekinumab
• Clinically important active infections, including active tuberculosis

Warnings and precautions

Important precautions mentioned in the source content include:

• Risk of infections, including reactivation of latent infections
• Extra caution in people with chronic infection or a history of recurrent infections
• Do not use in active tuberculosis
• Use caution with other immunosuppressants, including biological medicines, and during transitions from other immunosuppressive treatments
• History of cancer
• Older adults may have a higher incidence of infections
• Safety and efficacy are not established in children under 12 years for plaque psoriasis or psoriatic arthritis, and under 18 years for Crohn’s disease
• Risk of malignant tumors, both cutaneous and noncutaneous
• Risk of severe hypersensitivity reactions
• Do not administer live virus or bacteria vaccines
• Contraceptive measures are advised during treatment and up to 15 weeks after treatment
• Watch for signs of erythrodermal psoriasis or exfoliative dermatitis in patients with plaque psoriasis

Liver and kidney failure

The source content advises caution in liver failure and kidney failure because of a lack of studies. It does not provide dosage recommendations for these situations.

Interactions

The source content highlights an interaction concern with live attenuated vaccines. These should not be given at the same time.

Pregnancy and breastfeeding

The source content says there is no data in pregnancy and that, as a precaution, it is preferable to avoid use during pregnancy.

For breastfeeding, it is not known whether ustekinumab passes into human milk. Animal studies showed low concentrations in breast milk. The decision about breastfeeding during treatment and for up to 15 weeks after treatment should be made by weighing the benefits and risks with a healthcare professional.

Possible adverse reactions

The source content lists the following adverse reactions and side effects:

• Upper respiratory tract infection
• Nasopharyngitis
• Dental infections
• Dizziness
• Headache
• Pharyngeal pain
• Diarrhea
• Nausea
• Itching
• Back pain
• Myalgias
• Tiredness
• Erythema at the injection site

FAQ

Sources and references

This article was prepared using the source content provided and the following reference points:

• FDA medication guide and prescribing information
• FDA UNII record for ustekinumab
• ChemIDplus
• DrugPortal
• NCI Thesaurus