canakinumab (Ilaris)
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Indications
- hereditary periodic fever syndrome
- juvenile idiopathic arthritis[3]
- Still's disease[11]
- may reduce risk of gout flares in post MI patients[9]
- treatment of gout flares in adults with contraindications to NSAIDs, colchicine, or repeated courses of glucocorticoids (FDA-approved)[14]
- may risk of recurrent major cardiovascular events*[4]
- may reduce risk of lung cancer & lung cancer mortality[4][5]
- may reduce progression of osteoarthritis[12]
* no effect of serum cholesterol[4]
Contraindications
- does not prevent progression of prediabetes to type 2 diabetes[7]
- not approved for prevention of recurrent myocardial infarction in patients with heart failure
- does not increase likelihood of survival without mechanical ventilation[13]
Dosage
- subcutaneous injection every 8 weeks
- 150 mg patients with body weight greater than 40 kg
- 2 mg/kg with body weight 15-40 kg
- may increase to 3 mg/kg if inadequate response to 2 mg/kg
- 150 mg every 3 months for 15% cardiovascular risk reduction[4]
- 300 mg every 3 months associated with 77% reduction in fatal lung cancer[4]
Sterile, single-use 6-mL, glass vial containing 180 mg of Ilaris lyophilized powder for reconstitution
Monitor
- complete blood count (CBC) at baseline & every 3 months[2]
Adverse effects
- nasopharyngitis, diarrhea, influenza, headache, nausea
- increase in deaths due to infection (0.31 vs 0.18 for placebo per 100 person-years)[4][6]
- drug adverse effects of immunosuppressive agents
- drug adverse effects of biologic immunosuppressive agents
- drug adverse effects of pharmaceutical monoclonal antibodies
Mechanism of action
- fully humanized monoclonal antibody
- interleukin-1 beta antagonist[2]
Management
- whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent[2]
Notes
- cost of canakinumab U.S. 2017 is ~ $65,000-200,000/year[4]
More general terms
Additional terms
References
- ↑ Prescriber's Letter 17(2): 2010 New Drugs Approved by the FDA in 2009 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260213&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 2.0 2.1 2.2 2.3 2.4 Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
- ↑ 3.0 3.1 Deprecated Reference
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 Wendling p CANTOS: Anti-Inflammatory Drug Cuts CV Events, Cancer Medscape - Aug 27, 2017 http://www.medscape.com/viewarticle/884745
Ridker PM, Everett BM, Thuren T et al. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med 2017 Aug 27; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28845751 <Internet> http://www.nejm.org/doi/10.1056/NEJMoa1707914
Harrington RA. Targeting inflammation in coronary artery disease. N Engl J Med 2017 Aug 27 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28844177 <Internet> http://www.nejm.org/doi/10.1056/NEJMe1709904 - ↑ 5.0 5.1 Ridker PM, MacFadyen JG, Thuren T, et al Effect of interleukin-1beta inhibition with canakinumab on incident lung cancer in patients with atherosclerosis: exploratory results from a randomised, double-blind, placebo- controlled trial. Lancet. 2017 Aug 25. pii: S0140-6736(17)32247-X. PMID: https://www.ncbi.nlm.nih.gov/pubmed/28855077
- ↑ 6.0 6.1 Ridker PM, Everett BM, Thuren T et al Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med 2017; 377:1119-1131. September 21, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28845751 Free full text <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1707914
- ↑ 7.0 7.1 Wendling P CANTOS: Canakinumab Fails to Prevent New-Onset Diabetes. Medscape - Mar 14, 2018. https://www.medscape.com/viewarticle/893887
- ↑ 8.0 8.1 De Benedetti F, Gattorno M, Anton J et al Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes. N Engl J Med 2018; 378:1908-1919. May 17, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29768139 https://www.nejm.org/doi/full/10.1056/NEJMoa1706314
- ↑ 9.0 9.1 Walsh N IL-1 Blockade Appears Effective Against Gout. Canakinumab lowered the risk of attacks by more than half in post-MI patients. MedPage Today. June 14, 2018 https://www.medpagetoday.com/meetingcoverage/eular/73503
Solomon D et al Serum urate, gout, and cardiovascular disease in a randomized controlled trial of canakinumab: a CANTOS secondary analysis. European Congress of Rheumatology (EULAR) 2018; abstract OP0014. - ↑ NEJM J Watch editors Anti-inflammatory Agent Rejected as Heart Disease Drug. David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
- ↑ 11.0 11.1 Medscape. Aug 14, 2020 FDA Drug Approvals, Internal Medicine - 2020 Midyear Review. https://reference.medscape.com/viewarticle/935373
- ↑ 12.0 12.1 Schieker M et al. Effects of interleukin-1beta inhibition on incident hip and knee replacement: Exploratory analyses from a randomized, double-blind, placebo-controlled trial. Ann Intern Med 2020 Aug 4; PMID: https://www.ncbi.nlm.nih.gov/pubmed/32744862 https://www.acpjournals.org/doi/10.7326/M20-0527
- ↑ 13.0 13.1 Caricchio R, Abbate A, Gordeev I et al Effect of Canakinumab vs Placebo on Survival Without Invasive Mechanical Ventilation in Patients Hospitalized With Severe COVID-19. A Randomized Clinical Trial. JAMA. 2021;326(3):230-239 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34283183 https://jamanetwork.com/journals/jama/fullarticle/2782185
- ↑ 14.0 14.1 Hicks L FDA Approves Canakinumab for Gout Flares. Medscape. August 30, 2023 https://www.medscape.com/viewarticle/995993
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION ILARIS <TM> (canakinumab) for subcutaneous injection https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ilaris.pdf