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.
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UK | November 2021 | 160445

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Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at
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