Ilaris

canakinumab

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This is a summary of the European public assessment report (EPAR) for Ilaris. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ilaris.

For practical information about using Ilaris, patients should read the package leaflet or contact their doctor or pharmacist.

What is Ilaris and what is it used for?

Ilaris is a medicine for treating the following inflammatory conditions:

  • 4 types of periodic fever syndromes (diseases marked by recurring inflammation and fever) in adults and children aged 2 and above:
    • cryopyrin-associated periodic syndromes (CAPS);
    • tumour necrosis factor receptor associated periodic syndrome (TRAPS);
    • hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD);
    • familial mediterranean fever (FMF);
  • Still’s disease, a rare disease causing inflammation of joints as well as rash and fever (in adults and children aged 2 and above);
  • Gouty arthritis, painful inflammation of the joints caused by deposit of urate crystals (in adults).

Ilaris contains the active substance canakinumab.

How is Ilaris used?

Ilaris is given as a single injection under the skin every 8 weeks for CAPs and every 4 weeks for the other periodic fever syndromes (TRAPS, HIDS/MKD and FMF) and Still’s disease. In patients with gouty arthritis, a single injection is given on-demand to treat gouty arthritis attacks.

Injections are usually given in the upper thigh, upper arm, abdomen or buttocks. After proper training, patients or their caregivers may inject Ilaris themselves if the doctor deems it appropriate (for gouty arthritis the medicine should always be given by a healthcare professional). For information on doses and dose adjustments, see the summary of product characteristics (also part of the EPAR).

Ilaris can only be obtained with a prescription.

How does Ilaris work?

The active substance in Ilaris, canakinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a messenger molecule or ‘cytokine’ in the body called interleukin‑1 beta. This messenger is involved in causing inflammation and is found in high levels in patients with periodic fever syndromes, Still’s disease and gouty arthritis. By attaching to interleukin‑1 beta, canakinumab blocks its activity, helping to reduce inflammation thereby relieving the symptoms of the diseases.

What benefits of Ilaris have been shown in studies?

Periodic fever syndromes

Three studies involving 220 adults and children 2 years and older showed that Illaris was effective at reducing relapses of CAPS symptoms after a 24-week treatment period. In one of the studies, none of the patients with CAPS who received Ilaris during the 24-week treatment period had a relapse, compared with 81% of patients who received placebo (a dummy treatment). In the two other CAPS studies, which did not compare Ilaris with any other treatment, 85% of patients on Ilaris had no relapses at all. The proportion of patients with no relapse was lower (around 57%) for children aged 2 to 4 years.

A fourth study in 181 patients with other periodic fever syndromes found that Ilaris was more effective than placebo in achieving a response (symptoms resolved with no new flare ups). The response rates with Ilaris and placebo were 46% and 8%, respectively in patients with TRAPS, 35% and 6% in patients with HIDS/MKD, and 61% and 6% in patients with FMF.

Still’s disease

A study in 84 patients with childhood Still’s disease (also known as systemic juvenile idiopathic arthritis, SJIA) found that Ilaris was more effective than placebo at reducing symptoms of arthritis: around 84% of patients who received Ilaris achieved the required reduction in symptoms, compared with about 10% of patients who received placebo. In a second study in childhood Still’s disease (177 patients), the risk of experiencing a disease flare was reduced by 64% with Ilaris, compared with placebo. Ilaris treatment also allowed patients to reduce the amount of steroids they take to control inflammation.

Because of the similarities between childhood Still’s disease and the adult form (adult-onset Still’s disease, AOSD), Ilaris is expected to have similar benefits in adults.

Gouty arthritis

Two studies involving 454 patients with gouty arthritis showed that Ilaris was more effective than another anti-inflammatory medicine triamcinolone acetonide at reducing pain. In patients taking Ilaris, after 3 days, the pain level was reduced from 74 to 25 (on a standard rating scale from 0 to 100), whereas in patients taking the comparator the pain level was reduced from 74 to 35. The risk of developing a new gouty arthritis attack was also reduced with Ilaris (17% with Ilaris versus 37% with triamcinolone acetonide).

What are the risks associated with Ilaris?

Serious infections have been observed in patients taking Ilaris. The most common infections were of the nose and throat. Some infections were unusual or opportunistic infections due to reduced white blood cell levels. For the full list of all side effects reported with Ilaris, see the package leaflet.

Ilaris must not be used in patients with active or severe infection. For the full list of restrictions, see the package leaflet.

Why is Ilaris approved?

Studies have shown that Ilaris is effective at reducing symptoms or relapses in patients with periodic fever syndromes, Still’s disease and gouty arthritis. The main risk with this medicine is infection, mostly affecting the nose and throat. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits seen with Ilaris outweigh its risks and recommended that it be authorised in the EU.

Ilaris was originally authorised under ‘exceptional circumstances’, because, for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 22 March 2017.

What measures are being taken to ensure the safe and effective use of Ilaris?

The company that markets Ilaris will provide doctors who will use Ilaris with educational material containing the prescribing information, the patient reminder card and information for doctors containing important safety information about Ilaris, including precautions to be taken when using the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ilaris have also been included in the summary of product characteristics and the package leaflet.

Other information about Ilaris

The European Commission granted a marketing authorisation valid throughout the European Union for Ilaris on 23 October 2009.

For more information about treatment with Ilaris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Ilaris : EPAR - Summary for the public BG = bălgarski 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public ES = español 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public CS = čeština 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public DA = dansk 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public DE = Deutsch 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public ET = eesti keel 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public EL = elliniká 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public EN = English 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public FR = français 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public IT = italiano 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public LV = latviešu valoda 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public LT = lietuvių kalba 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public HU = magyar 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public MT = Malti 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public NL = Nederlands 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public PL = polski 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public PT = português 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public RO = română 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public SK = slovenčina 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public SL = slovenščina 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public FI = suomi 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public SV = svenska 2009-11-12 2017-05-17
Ilaris : EPAR - Summary for the public HR = Hrvatski 2009-11-12 2017-05-17

This EPAR was last updated on 17/05/2017 .

Authorisation details

Product details

Product details for Ilaris
NameIlaris
Agency product numberEMEA/H/C/001109
Active substance

canakinumab

International non-proprietary name (INN) or common name

canakinumab

Therapeutic area Cryopyrin-associated Periodic SyndromesArthritis, Juvenile RheumatoidArthritis, Gouty
Anatomical therapeutic chemical (ATC) code L04AC08

Publication details

Publication details for Ilaris
Marketing-authorisation holder

Novartis Europharm Ltd

Revision18
Date of issue of marketing authorisation valid throughout the European Union23/10/2009

Contact address:

Novartis Europharm Ltd
Frimley Business Park
Camberley
GU16 7SR
United Kingdom

Product information

Product information

23/03/2017  Ilaris -EMEA/H/C/001109 -S/0047

Name Language First published Last updated
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17
Ilaris : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-05-17

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02
Ilaris : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12 2017-03-02

Name Language First published Last updated
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  
Ilaris : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-12  

Pharmacotherapeutic group

Interleukin inhibitors

Therapeutic indication

Periodic fever syndromes

Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:

Cryopyrin-associated periodic syndromes

Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:

  • Muckle-Wells syndrome (MWS),
  • Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA),
  • Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.

 Tumour necrosis factor receptor associated periodic syndrome (TRAPS)

Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).

Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD)

Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).

Familial Mediterranean fever (FMF)

Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate.

 Ilaris is also indicated for the treatment of:

Still’s disease

Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.

Gouty arthritis

Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1). 

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ilaris : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2010-04-27 2017-05-17
Ilaris-H-C-1109-X-0045-G : EPAR - Assessment Report - Variation HR = Hrvatski 2017-03-02  
CHMP post-authorisation summary of positive opinion for Ilaris HR = Hrvatski 2016-12-16  
Ilaris-H-C-1109-P46-049 : EPAR - Assessment Report - Variation HR = Hrvatski 2016-10-07  
Ilaris-H-C-1109-P460-48 : EPAR - Assessment Report - Variation HR = Hrvatski 2016-09-13  
Ilaris-H-C-1109-II-0043 : EPAR - Assessment Report - Variation HR = Hrvatski 2016-09-08  
CHMP post-authorisation summary of positive opinion for Ilaris HR = Hrvatski 2016-06-24  
Ilaris : EPAR - Paediatric investigation plan compliance statement HR = Hrvatski 2016-01-08  
Ilaris-H-C-1109-P46-0043 : EPAR - Assessment Report - Variation HR = Hrvatski 2015-10-05  
Ilaris-H-C-1109-P46-0041 : EPAR - Assessment Report HR = Hrvatski 2015-05-20  
Ilaris-H-C-1109-P46-0040 : EPAR - Assessment Report HR = Hrvatski 2015-05-20  
Ilaris-H-C-1109-PSUV-0032 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 2014-10-01  
Ilaris-H-C-1109-II-0026 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-10-11  
CHMP post-authorisation summary of positive opinion for Ilaris HR = Hrvatski 2013-07-26  
Ilaris-H-C-1109-II-0010 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-04-02  
Ilaris-H-C-1109-II-0021 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-04-02  
CHMP post-authorisation summary of positive opinion for Ilaris HR = Hrvatski 2013-01-18  
CHMP post-authorisation summary of positive opinion for Ilaris HR = Hrvatski 2012-12-14  

Initial marketing-authorisation documents

Name Language First published Last updated
Ilaris : EPAR - Public assessment report HR = Hrvatski 2009-11-12  
Committee for medicinal products for human use, summary of positive opinion for Ilaris HR = Hrvatski 2009-07-24  

Authorised

This medicine is approved for use in the European Union

More information on Ilaris

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 20 March 2007. Upon request of the marketing-authorisation holder, Ilaris has now been removed from the Community register of orphan medicinal products.