Author: Janssen-Cilag International NV


Long information

What is it?

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.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

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.

How is it used?

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.

How does it work?

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.

How has it been studied?

Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with moderate to severe plaque psoriasis. Over half of the patients had failed one or more other treatments for psoriasis or could not receive them. Both studies looked at two doses of Stelara (45 and 90 mg). The main measure of effectiveness was the number of patients who ?responded? to treatment after 12 weeks, meaning that symptom scores improved by 75% or more. The studies were still ongoing at the time of the medicine?s assessment and are scheduled to last for up to five years. The company also provided some of the longer-term results of one of the studies (after 18 months of treatment), and the early results of an ongoing study comparing Stelara with etanercept (another medicine for psoriasis).

What benefits has it shown during the studies?

Stelara was more effective than placebo at improving the symptoms of psoriasis. Looking at the results of the two main studies taken together, around 69% of the patients receiving Stelara responded to treatment after 12 weeks, compared with around 3% of the patients receiving placebo. There was no difference in response rates between the two doses of Stelara in patients weighing below 100 kg. Patients weighing over 100 kg had a better response to the 90-mg dose. The longer-term results showed that with continuous treatment, the response to Stelara is maintained for at least 18 months. The ongoing comparative study has shown that Stelara is more effective than etanercept after 12 weeks of treatment.

What is the risk associated?

The most common side effects with Stelara (seen in more than 1 patient in 10) are upper respiratory tract infection (colds) and nasopharyngitis (inflammation of the nose and throat). For the full list of all side effects reported with Stelara, see the Package Leaflet.
Stelara should not be used in people who may be hypersensitive (allergic) to ustekinumab or any of the other ingredients. It must not be used in patients who have an active infection that the doctor considers important. The doctor may interrupt treatment in patients who develop a serious infection.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that Stelara has a new mode of action, blocking the activity of two messenger molecules (interleukin-12 and interleukin-23) rather than only one. The Committee also noted that unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression were seen in some studies and that these might be related to Stelara. Therefore, based on the information currently available, the CHMP decided to restrict the use of the medicine to patients in whom other treatments had failed or who could not receive them. The Committee decided that Stelara?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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