Canakinumab

(Ilaris®)

Ilaris®

Drug updated on 7/25/2024

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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  • Canakinumab (Ilaris) is indicated for the treatment of periodic fever syndromes and gout flares in specific patient populations.
  • The information was derived from 16 systematic reviews/meta-analyses studies.
  • In treating gout flares, canakinumab showed superior effectiveness compared to standard treatments like NSAIDs and colchicine, with a favorable safety profile primarily in adult patients.
  • For Familial Mediterranean Fever (FMF), canakinumab achieved up to 81% complete remission in pediatric patients, showing high effectiveness alongside Anakinra; adverse events were slightly higher in adults than children.
  • Canakinumab demonstrated significant efficacy across various immune-mediated diseases such as CAPS, FMF, sJIA, and other IL-1 mediated conditions while being generally well-tolerated but associated with some respiratory infections and gastrointestinal issues.
  • During pregnancy studies involving inflammatory disease treatments with canakinumab or anakinra, most babies were born healthy despite some preterm births; the focus was on safety rather than effectiveness.
  • In Schnitzler syndrome cases reviewed across seven publications involving 34 patients, canakinumab provided a complete response rate of 58.6%, though infections were noted as frequent adverse events among this population group.
  • For systemic juvenile idiopathic arthritis (sJIA), meta-analysis revealed that canakinumab had the highest probability of efficacy compared to other biologics like Anakinra or Tocilizumab without significant differences in serious adverse events between these treatments.

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