Ilaris is a powder that is made up into a solution for injection. It contains the active substance canakinumab (150 mg).
|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?|
Ilaris is used to treat cryopyrin-associated periodic syndromes (CAPS). CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopirin. This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain and tiredness. Severe disabilities such as deafness and loss of vision may also occur.
Ilaris is used to treat adults and children aged four years and older with a body weight of above 15 kg, who have the following types of CAPS:
- Muckle-Wells syndrome (MWS);
- neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous, articular syndrome (CINCA);
- severe forms of familial cold autoinflammatory syndrome (FCAS) and familial cold urticaria (FCU) with signs and symptoms beyond urticarial skin rash (hives) caused by cold.
The medicine can only be obtained with a prescription.
Treatment with Ilaris should be started and supervised by a specialist doctor experienced in diagnosing and treating CAPS.
Ilaris is given as injections under the skin. For patients weighing from 15 to 40 kg the recommended dose is 2 mg per kilogram body weight as a single injection every eight weeks. For patients weighing more than 40 kg, the recommended dose is 150 mg every eight weeks. If the patient?s symptoms do not improve after seven days, a second dose can be considered and if the symptoms subsequently improve the patients should then be maintained on a double dose (300 mg or 4 mg/kg) every eight weeks.
Patients may inject themselves once they have been trained if their doctor believes it is appropriate. Patients treated with Ilaris must be given an alert card that that summarises the key safety information about the medicine.
The active substance in Ilaris, canakinumab, 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) that is found on certain cells in the body. Canakinumab has been designed to attach to an antigen called interleukin-1 beta, which is produced in high levels in patients with CAPS, causing inflammation. By attaching to interleukin-1 beta, canakinumab blocks its activity, helping to relieve the symptoms of the disease.
The effects of Ilaris were first tested in experimental models before being studied in humans. In one main study involving 35 adults and children with CAPS, patients were given one injection of Ilaris and after eight weeks those who responded to treatment were then given either Ilaris or placebo (a dummy treatment) every eight weeks for the next 24 weeks. In the following 16 weeks, all patients received Ilaris every eight weeks. The main measure of effectiveness was the number of patients who did not have a ?disease flare? (relapse of symptoms) after the 24-week treatment period.
Ilaris was more effective than placebo at treating patients with CAPS. None of the 15 patients who received Ilaris during the 24-week treatment period had a ?disease flare? compared with 81% of patients who received placebo (13 out of 16).
The most common side effects with Ilaris (seen in more than 1 patient in 10) are nasopharyngitis (inflammation of the nose and throat), vertigo (a spinning sensation) and reactions at the injection site. For the full list of all side effects reported with Ilaris, see the package leaflet.
Ilaris should not be used in people who may be hypersensitive (allergic) to canakinumab or any of the other ingredients. It must not be used in patients with active or severe infection. Because Ilaris may be associated with serious infection, patients should be monitored carefully for signs and symptoms of infection during and after treatment with the medicine.Ilaris Page
The CHMP decided that Ilaris?s benefits are greater than its risks and recommended that it be given marketing authorisation.
Ilaris has been authorised under ?Exceptional Circumstances?. This means that because the disease is rare, it has not been possible to obtain complete information about Ilaris. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.