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Drug updated on 4/17/2024

Dosage FormInjection (subcutaneous; 150 mg/mL)
Drug ClassInterleukin-1β blockers
Ongoing and
Completed Studies


  • Indicated for the treatment of periodic fever syndromes: Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including: Familial Cold Auto-inflammatory Syndorme (FCAS) and Muckle-Wells Syndrome (MWS).
  • Indicated for the treatment of periodic fever syndromes: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients.
  • Indicated for the treatment of periodic fever syndromes: Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients.
  • Indicated for the treatment of periodic fever syndromes: Familial Mediterranean Fever (FMF) in adult and pediatric patients.
  • 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.
  • Indicated for the treatment of Gout flares in adults 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.

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  • Canakinumab (Ilaris) is a human monoclonal antibody targeting interleukin-1 beta, used for treating various auto-inflammatory syndromes such as Cryopyrin-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, Familial Mediterranean Fever, Active Still’s Disease, and Gout flares.
  • Fifteen systematic reviews/meta-analyses were analyzed to gather information about the drug's effectiveness and safety profile.
  • In comparison with triamcinolone in Gout flare treatment scenarios where standard therapies are unsuitable, canakinumab significantly improved patient outcomes by reducing serum hsCRP and Amyloid A levels, along with improving patient and physician global assessments. It also outperformed anakinra and rilonacept in reducing Visual Analogue Scale score frequency of gout flares.
  • For Familial Mediterranean Fever cases resistant or intolerant to colchicine; both adult and pediatric populations displayed high efficacy rates under anti-interleukin therapy using canakinumab. Studies indicated that 60% of adult patients achieved complete remission, while this figure was higher at 81% for pediatric patients.
  • Canakinumab demonstrated significant efficacy in producing complete remission of systemic manifestations associated with Adult-Onset Still’s Disease and had the highest probability of being the best treatment option for Systemic Juvenile Idiopathic Arthritis without posing any significant risk related to serious adverse events.
  • Pregnancy-related considerations indicate that the use of canakinumab did not increase the rate of adverse perinatal outcomes, suggesting its safe usage during the pregnancy period when dealing with inflammatory diseases.
  • In terms of attack prevention and inflammation reduction, especially in colchicine-resistant Familial Mediterranean Fever cases, evidence suggested favorable outcomes with canakinumab, which resulted in a significant reduction in participants experiencing attacks and a decrease in CRP levels.
  • The comparative analysis with other treatments such as corticosteroids, NSAIDs, and IL-1β inhibitors like anakinra and rilonacept showed that canakinumab often had superior efficacy in symptom control, along with a manageable safety profile.

Product Monograph / Prescribing Information

Document TitleYearSource
Ilaris (canakinumab) Prescribing Information. 2023Novartis Pharmaceuticals Corporation East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Interleukin-1β inhibitors for the management of acute gout flares: a systematic literature review.2023Arthritis Research & Therapy
Efficacy and safety of anti-ınterleukin-1 treatment in familial Mediterranean fever patients: a systematic review and meta-analysis.2023Rheumatology
The effect of canakinumab on clinical outcomes in patients with COVID-19: a meta-analysis.2022Journal of Infection
Systematic review of safety and efficacy of IL-1-targeted biologics in treating immune-mediated disorders.2022Frontiers in Immunology
Interventions for reducing inflammation in familial Mediterranean fever. 2022The Cochrane Database of Systematic Reviews
Efficacy and safety of canakinumab in the treatment of adult-onset Still's disease: a systematic review.2021Seminars in Arthritis and Rheumatism
A systematic review of the safety of blocking the IL-1 system in human pregnancy.2021Journal of Clinical Medicine
Effect of canakinumab on clinical and biochemical parameters in acute gouty arthritis: A meta-analysis.2021Inflammopharmacology
Update on the therapy of adult-onset Still's disease with a focus on IL-1-inhibition: a systematic review. 2021Therapeutic Advances in Musculoskeletal Disease
Comparison of the efficacy and safety of biological agents in patients with systemic juvenile idiopathic arthritis: a Bayesian network meta-analysis of randomized controlled trials.2021International Journal of Clinical Pharmacology and Therapeutics
Efficacy and safety of pharmacologic interventions in patients experiencing a gout flare: a systematic review and network meta-analysis.2021Arthritis Care & Research
Efficacy and safety of canakinumab treatment in Schnitzler syndrome: a systematic literature review.2020Seminars in Arthritis and Rheumatism
The efficacy, safety and tolerability of canakinumab in the treatment of familial mediterranean fever: a systematic review of the literature.2020Journal of Inflammation Research
Systematic literature review of efficacy/effectiveness and safety of current therapies for the treatment of cryopyrin-associated periodic syndrome, hyperimmunoglobulin D syndrome and tumour necrosis factor receptor-associated periodic syndrome.2020Rheumatic & Musculoskeletal Diseases Open
A systematic literature review of efficacy, effectiveness and safety of biologic therapies for treatment of familial Mediterranean fever.2020Rheumatology
The right place of interleukin-1 inhibitors in the treatment of Bechet’s syndrome: a systematic review.2019Rheumatology International

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