Stelara (ustekinumab)

Stelara is a solution for injection that contains the active substance ustekinumab. It is available in a vial or in a prefilled syringe. Each vial or syringe contains either 45 or 90 mg ustekinumab.

Stelara is used to treat adults with moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in patients who failed to respond to or cannot use other systemic (whole-body) treatments for psoriasis, including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A). PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen’ before being exposed to ultraviolet light.

The medicine can only be obtained with a prescription.

Stelara is given under the supervision of a doctor who has experience in diagnosing and treating psoriasis.

It is given as an injection under the skin at a dose of 45 mg. This is followed by a further injection four weeks later, and then an injection every three months (12 weeks). The doctor should consider stopping treatment if there is no response after 28 weeks. Patients weighing over 100 kg should be given Stelara in 90-mg doses.

Patients may inject themselves once they have been trained, if their doctor thinks that this is appropriate.

The active substance in Stelara, ustekinumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Ustekinumab has been designed to attach to a protein called ‘IL-12/23p40’. This protein forms part of two of the cytokines (messenger molecules) in the immune system called interleukin-12 and interleukin-23. These cytokines are involved in causing the inflammation and other processes that cause psoriasis. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.

The European Commission granted a marketing authorisation valid throughout the European Union for Stelara to Janssen-Cilag International NV on 16 January 2009. The marketing authorisation is valid for five years, after which it can be renewed.