Prescribing information



ILARIS is the first and only selective IL-1β inhibitor for the treatment of FMF, HIDS/MKD, TRAPS and CAPS in adults, adolescents and children aged ≥2 years.1



ILARIS mechanism of action


ilaris circle
ILARIS is a fully human monoclonal antibody that neutralises the proinflammatory cytokine IL-1β to reduce inflammation.1,2


 Image showing the mode of action of ILARIS in periodic fever syndromes

Image created using information from references 1, 2 and 6


*Complete response was defined as resolution of the baseline flare at day 15 (PGA score <2 plus CRP ≤10 mg/L or a reduction by ≥70% from baseline) and no new flare (PGA score ≥2 and CRP ≥30 mg/L) up to Week 16.1
Complete response was defined as composite of PGA of autoinflammatory disease activity, and assessment of no or minimal skin disease, and CRP or SAA values <10 mg/L. PGA of disease activity was based on a composite of the following symptoms: urticarial skin rash, arthralgia, myalgia, headache/migraine, conjunctivitis and fatigue/malaise.2


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

  • 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
  • FMF
    • ILARIS should be given in combination with colchicine, if appropriate.

CAPS, cryopyrin-associated periodic syndromes; CRP, c-reactive protein; FMF, familial Mediterranean fever; HIDS, hyperimmunoglobulin D syndrome; IL, interleukin; MKD, mevalonate kinase deficiency; PGA, physician global assessment; SAA, serum amyloid A; TRAPS, tumour necrosis factor receptor-associated periodic syndrome.


  1. ILARIS® (canakinumab) Summary of Product Characteristics.
  2. Lachmann HJ et al. Arthritis Rheum 2011;63(2):314–324.
  3. De Benedetti F et al. N Engl J Med 2018;378:1908–1919.
  4. Kuemmerle-Deschner J et al. Pediatr Rheumatol 2015;13(Suppl 1):P3.
  5. NHS England. Clinical Commissioning Policy: Canakinumab for treating periodic fever syndromes: TRAPS, HIDS/MKD and FMF (ages 2 years and older). February 2020. Available at: [Accessed July 2021].
  6. Lin YT et al. Autoimmun Rev 2011;10(8):482–489.
Rate this content: 
No votes yet
UK | November 2021 | 160445

Ask Speakers


Medical Information Request

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Novartis via or online through the pharmacovigilance intake (PVI) tool at
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at