Canakinumab

(Ilaris®)

Ilaris®

Drug updated on 11/1/2024

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 Stills disease, including Adult-Onset Stills 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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  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • In AOSD (Adult-onset Still's disease), canakinumab achieved complete remission in 68.7% of 99 patients and showed a complete remission rate of 77% (95% CI (confidence interval) 29-97%) with corticosteroid discontinuation in 34% (95% CI 6-81%), while effectiveness and safety were reported in refractory cases.
  • For Gout Flares, canakinumab and rilonacept effectively reduced flare frequency and pain, with canakinumab providing the highest pain reduction by day 2 and at follow-up, outperforming corticosteroids and NSAIDs.
  • In FMF, canakinumab was effective in 60% of adult patients and 81% of pediatric patients and likely reduced attack frequency in colchicine-resistant cases by 16 weeks.
  • CAPS patients responded positively to canakinumab and other IL-1 blockers, with studies indicating effectiveness across IL-1 inhibitor options.
  • AOSD: Among 69 patients treated with IL-1 inhibitors, 210 adverse events were reported, with respiratory tract infections, arthralgia, disease flares, abdominal pain, nausea, and diarrhea being common. Severe adverse events included macrophage activation syndrome and serious infections.
  • Gout Flares: IL-1 inhibitors (canakinumab, anakinra, rilonacept) were mostly well-tolerated, with moderate certainty evidence suggesting canakinumab may have a superior safety profile compared to corticosteroids and NSAIDs.
  • FMF: Adverse events occurred in 25% of adult patients and 12% of pediatric patients treated with canakinumab, with fewer serious adverse events compared to placebo in colchicine-resistant cases. Injection-site reactions were frequently observed for anakinra, rilonacept, and etanercept.
  • Canakinumab demonstrated effectiveness across various populations, including adult and pediatric patients with conditions like AOSD, gout flares, FMF (with greater efficacy in pediatric FMF patients), and CAPS; IL-1 blockade during pregnancy showed no increase in adverse perinatal outcomes.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Systematic Review and Metaanalysis of Pharmacological Interventions in Adult-Onset Still Disease and the Role of Biologic Disease-Modifying Antirheumatic Drugs2024The Journal Of Rheumatology
Efficacy and safety of anti-interleukin-1 treatment in familial Mediterranean fever patients: a systematic review and meta-analysis2024Rheumatology (Oxford, England)
Interleukin-1beta inhibitors for the management of acute gout flares: a systematic literature review2023Arthritis Research & Therapy
Systematic Review of Safety and Efficacy of IL-1-Targeted Biologics in Treating Immune-Mediated Disorders2022Frontiers In Immunology
Interventions for reducing inflammation in familial Mediterranean fever2022The Cochrane Database Of Systematic Reviews
Efficacy and safety of canakinumab in the treatment of adult-onset Still's disease: A systematic review2021Seminars In Arthritis And Rheumatism
Update on the therapy of adult-onset Still's disease with a focus on IL-1-inhibition: a systematic review2021Therapeutic Advances In Musculoskeletal Disease
Efficacy and Safety of Pharmacologic Interventions in Patients Experiencing a Gout Flare: A Systematic Review and Network Meta-Analysis2021Arthritis Care & Research
A Systematic Review of the Safety of Blocking the IL-1 System in Human Pregnancy2021Journal Of Clinical Medicine
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 syndrome2020Rmd Open
A systematic literature review of efficacy, effectiveness and safety of biologic therapies for treatment of familial Mediterranean fever2020Rheumatology (Oxford, England)
The Efficacy, Safety and Tolerability of Canakinumab in the Treatment of Familial Mediterranean Fever: A Systematic Review of the Literature2020Journal Of Inflammation Research
Management of adult-onset Still's disease with interleukin-1 inhibitors: evidence- and consensus-based statements by a panel of Italian experts2019Arthritis Research & Therapy

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