What is Stelara?
Stelara is a solution for injection containing the active substance ustekinumab.
What is Stelara used for?
Stelara is used to treat moderate to severe adults with plaque psoriasis (a disease that causes red, scaly patches on the skin). The medicine is used in patients who have not responded or who cannot use other systemic therapies (affecting the whole organism) for psoriasis including cyclosporine, methotrexate and PUVA (psoralen + UV-A rays). PUVA therapy is a type of treatment in which the patient receives a medicine containing a compound called 'psoralen' before being exposed to ultraviolet light.
The medicine can only be obtained with a prescription.
How is Stelara used?
Stelara is administered under the supervision of a doctor experienced in the diagnosis and treatment of psoriasis.
The medicine is given as an injection under the skin at a dose of 45 mg. Another injection follows four weeks later, and then an injection every three months (12 weeks). The doctor should consider discontinuing treatment if there is no response after 28 weeks. Patients weighing more than 100 kg must receive Stelara at doses of 90 mg.
If the doctor considers it appropriate, patients can practice self-injection after receiving specific instructions.
How does Stelara work?
The active substance in Stelara, ustekinumab, is a monoclonal antibody, which is an antibody (type of protein) that was designed to recognize a specific structure (called an antigen) in the body and bind to it. Ustekinumab was designed to bind to a protein called 'IL-12 / 23p40'. This protein is part of two of the messenger molecules (cytokines) of the immune system, interleukin-12 and interleukin-23. These interleukins participate in 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.
What studies have been carried out on Stelara?
The effects of Stelara were first tested in experimental models before being studied in humans.
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. In more than half of the patients, one or more of the other psoriasis therapies had failed or these patients could not receive them. Both studies examined two doses of Stelara (45 and 90 mg). The main measure of effectiveness was the number of patients who 'responded' to therapy after 12 weeks, ie where symptom scores had improved by 75% or more. The studies were still ongoing at the time the medicine was evaluated and are expected to last for up to five years.
The company provided some of the longer term results of one of the studies (after 18 months of treatment) and the first results of an ongoing study on the comparison of Stelara with etanercept (another medicine for psoriasis).
What benefit has Stelara shown during the studies?
Stelara was more effective than placebo in improving psoriasis symptoms. Looking at the results of the two main studies put together, about 69% of the patients receiving Stelara responded to therapy after 12 weeks, compared with about 3% of patients receiving placebo. There were no differences in response rates between the two doses of Stelara in patients weighing less than 100 kg. Patients weighing over 100 kg showed a better response to the 90 mg dose. Longer-term results showed that by continuing therapy, the response to Stelara is maintained for at least 18 months. The ongoing comparative study showed that Stelara is more effective than etanercept after 12 weeks of treatment.
What is the risk associated with Stelara?
The most common side effects of 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 substances. The medicine should not be used in patients who have an active infection that the doctor considers important. Your doctor may stop treatment in patients who develop a serious infection.
Why has Stelara been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that Stelara has a new mode of action, which blocks the activity of two messenger molecules (interleukin-12 and interleukin-23) instead of just one. The Committee also noted that in some studies unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression were observed and that these could be associated with Stelara. Therefore, based on the information currently available, the CHMP decided to limit the use of the medicine to patients whose other therapies had failed or could not receive them.
The Committee decided that Stelara's benefits are greater than its risks for the treatment of moderate to severe plaque psoriasis in adults who have not responded or have a contraindication or are intolerant to other systemic therapies, including cyclosporine, methotrexate and PUVA . The committee recommended that Stelara be given marketing authorization.
What measures will be taken to ensure the safe use of Stelara?
The company that makes Stelara will offer training programs for doctors and patients. These will focus on the safety of Stelara, in particular on the risks of developing Tuberculosis, other infections and cancers. The patient program will also include detailed instructions for injecting Stelara.
Other information on Stelara:
On 16 January 2009, the European Commission issued a marketing authorization valid throughout the European Union for Stelara to Janssen-Cilag International NV.
For the full EPAR version of Stelara, click here.
Last update of this summary: 12-2008.
