What is Ilaris?
Ilaris is a powder for the preparation of a solution to be administered by injection. The active substance contained in it is canakinumab (150 mg).
What is Ilaris used for?
Ilaris is indicated for the treatment of cryopirine-associated periodic syndromes (CAPS), a group of diseases caused by a defect in the gene that produces cryopirin, a protein. Sufferers suffer from inflammation in most parts of the body with symptoms such as fever, rash, joint pain and tiredness.
Ilaris is used to treat adults and children at least 4 years old and body weight over 15 kg affected by the following types of CAPS:
• Muckle-Wells syndrome (MWS);
• neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological syndrome, cutaneous, joint (CINCA);
• severe forms of familial autoinflammatory cold syndrome (FCAS) and familial cold urticaria (FCU) that manifest with signs and symptoms as well as cold-induced skin rash (urticaria).
Because the number of patients with CAPS is low, the disease is considered "rare" and Ilaris was designated an "orphan medicine" (a medicine used in rare diseases) on March 20, 2007.
The medicine can only be obtained with a prescription.
How is Ilaris used?
Treatment with Ilaris should be established and controlled by a specialist with experience in the diagnosis and treatment of CAPS.
Ilaris is given as an injection under the skin. For patients weighing between 15 and 40 kg the recommended dose is 2 mg per kg of body weight given 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 may be considered and, if the symptoms improve later, patients will have to follow a maintenance regimen with a double dose (300 mg or 4 mg / kg) given every eight weeks.
Patients can perform the injection themselves after training and if the doctor considers it appropriate. Patients treated with Ilaris should be given a card that summarizes the main data on the safety of the medicine.
How does Ilaris work?
The active ingredient of Ilaris is canakinumab, a monoclonal antibody, or an antibody (a type of protein) made to recognize a specific structure (antigen) present on some human cells and bind to it. Canakinumab was made to bind to an antigen, interleukin-1 beta, which is produced in large quantities in patients with CAPS, causing inflammation. By binding to interleukin-1 beta, canakinumab inhibits its activity, helping to alleviate the symptoms of the disease.
What studies have been carried out on Ilaris?
The effects of Ilaris were first tested in experimental models before being studied in beings
human. In one main study, an injection of Ilaris was given to 35 patients with CAPS (adults and children); after eight weeks, patients who had responded to treatment began a 24-week cycle that included the administration of Ilaris or placebo (a dummy treatment) every eight weeks. In the following 16 weeks all patients received a dose of Ilaris every eight weeks. The main efficacy parameter was the number of patients who did not experience an exacerbation of the disease (reappearance of symptoms) after the 24 weeks of treatment.
What benefit has Ilaris shown during the studies?
Ilaris was more effective than placebo in treating patients with CAPS. In none of the 15 patients treated with Ilaris during the 24 weeks of treatment there was an exacerbation of the disease compared to 81% of patients treated with placebo (13 of 16).
What is the risk associated with Ilaris?
The most common side effects for Ilaris (seen in more than 1 patient in 10) are nasopharyngitis
(inflammation of the nasal passages and throat), dizziness 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 patients who may be hypersensitive (allergic) to canakinumab or any of the other ingredients. It should also not be used in patients with severe or ongoing infection.
Because Ilaris may be associated with serious infections, patients should be closely monitored for signs or symptoms of infection during and after treatment with the medicine.
Why has Ilaris been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ilaris's benefits are greater than its risks for the treatment of cryopirin-associated periodic syndromes (CAPS), and recommended that Ilaris be given marketing authorization.
The authorization of this medicine was issued in "exceptional circumstances". This means that, given the rarity of the disease, it has not been possible to obtain complete information on Ilaris. Every year the European Medicines Agency will review any new information that may be available and, if necessary, this summary will be updated.
What information is still awaited for Ilaris?
The company that produces Ilaris has undertaken to provide safety information periodically and
the efficacy of Ilaris in adults and children placed in a special register and to carry out a study on children to better understand the fate of the medicine once in the body.
What measures are being taken to ensure the safe use of Ilaris?
The company that makes Ilaris will provide doctors in all the Member States who use the medicine with a package including instructions for prescribing the medicine, the patient card and directions for doctors about possible side effects and the appropriate use of the medicine.
More information on Ilaris
The European Commission granted a marketing authorization valid throughout the European Union for Ilaris to Novartis Europharm Limited on 23 October 2009.
For a summary of the opinion of the Committee for Orphan Medicinal Products on Ilaris, click here.
For the full EPAR for Ilaris, click here.
Last update of this summary: 08-2009.
