Canakinumab

(Ilaris®)

Ilaris®

Drug updated on 9/4/2024

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

Indication

  • 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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Summary
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  • Ilaris (canakinumab) is 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 Syndrome (FCAS) and Muckle-Wells Syndrome (MWS); the treatment of periodic fever syndromes: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients; the treatment of periodic fever syndromes: Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients; the treatment of periodic fever syndromes: Familial Mediterranean Fever (FMF) in adult and pediatric patients; 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; and 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.
  • This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-16]
  • Gout Flares: Canakinumab and rilonacept showed superior effectiveness compared to active comparators in pain resolution and reducing flare frequency, while anakinra was not inferior to active comparators for pain resolution.
  • Familial Mediterranean Fever (FMF): Anti-IL-1 agents (canakinumab, anakinra, rilonacept) achieved complete remission in 60% of adult patients and 81% of pediatric patients, along with a significant decrease in inflammatory markers.
  • Systemic Juvenile Idiopathic Arthritis (sJIA): Canakinumab demonstrated the highest probability of achieving the best treatment response (modified ACRpedi30), followed by anakinra, tocilizumab, and rilonacept.
  • Adult-Onset Still's Disease (AOSD): Canakinumab led to complete remission in 68.7% of patients, partial improvement in 16.2%, and no clinical improvement in 15.1%.
  • Gout Flares: Canakinumab, anakinra, and rilonacept were mostly well-tolerated, with no significant differences in the incidence of serious adverse events reported.
  • FMF: Adverse events occurred in 25% of adult patients and 12% of pediatric patients treated with anti-IL-1 agents.
  • AOSD: Canakinumab treatment was associated with 210 adverse events, the most common being respiratory tract infections. Severe adverse events included macrophage activation syndrome and serious infections.
  • Population Types and Subgroup Considerations: Pediatric patients with Familial Mediterranean Fever (FMF) had higher remission rates (81%) compared to adults (60%); patients with Adult-Onset Still's Disease (AOSD) varied in disease severity and previous treatments; for Schnitzler Syndrome, patients varied but subgroup specifics were not detailed; systemic Juvenile Idiopathic Arthritis (sJIA) studies included both pediatric and adult populations, but specific subgroup details were not provided.

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

Clinical Practice Guidelines