Canakinumab for gout: A specific, patient-profiled indication

Expert Review of Clinical Immunology

Volumn 10, Issue 3, 2014, Pages 339-347

  Perez Ruiz, Fernando ^a,b   Chinchilla, Sandra P ^a   Herrero Beites, Ana María ^b,c  

^a HOSPITAL DE CRUCES   (Spain)

^b BIOCRUCES BIZKAIA HEALTH RESEARCH INSTITUTE   (Spain)

^c Hospital de Gorliz   (Spain)

Author keywords

canakinumab; gout; gout suppressants; IL 1; monoclonal antibodies; treatment

Indexed keywords

ANTIBODIES, BLOCKING; ANTIBODIES, MONOCLONAL; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; EUROPEAN UNION; GOUT; GOUT SUPPRESSANTS; HUMANS; INDIVIDUALIZED MEDICINE; INFLAMMATION MEDIATORS; INTERLEUKIN-1BETA; URIC ACID;

EID: 84894381672     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2014.880653     Document Type: Article

References (32)

1. Yu TF, Gutman AB. Principles of current management of primary gout. Am J Med Sci 1967;254:893-907
2. De Miguel E, Puig JG, Castillo C, et al. Diagnosis of gout in patients with asymptomatic hyperuricaemia: a pilot ultrasound study. Ann Rheum Dis 2011;71: 157-8
3. Martin WJ, Shaw O, Liu X, et al. Monosodium urate monohydrate crystal-recruited noninflammatory monocytes differentiate into M1-like proinflammatory macrophages in a peritoneal murine model of gout. Arthritis Rheum 2011;63:1322-32
4. Martinon F, Petrilli V, Mayor A, et al. Gout-associated uric acid crystals activate the NALP3 inflammasome. Nature 2006;440:237-41
5. Yagnik DR, Evans BJ, Florey O, et al. Macrophage release of transforming growth factor b1 during resolution of monosodium urate monohydrate crystal-induced inflammation. Arthritis Rheum 2004;50: 2273-80
6. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken) 2012;64:1447-61
7. Dinarello CA, Simon A, van der Meer JW. Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases. Nat Rev Drug Discov 2012;11: 633-52
8. EMEA/H/C/363. EPAR summary for the public. Kineret Anakinra. 2011. Available from: www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/ medicines/000363/human-med-000874. jsp&mid=WC0b01ac058001d124
9. Committee for Medicinal Products for Human Use (CHMP). Summary of opinion (post authorisation). Kineret-anakinra. 2013. Available from: www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion/human/000363/ WC500150030.pdf
10. Chen K, Fields T, Mancuso CA, et al. Anakinra's efficacy is variable in refractory gout: report of ten cases. Semin Arthritis Rheum 2010;40:210-14
11. Moltó A, Ea HK, Richette P, et al. Efficacy of anakinra for refractory polyarticular gout and acute CPP arthritis. Ann Rheum Dis 2012;70(Suppl 3):183
12. Funck-Brentano T, Salliot C, Leboime A, et al. First observation of the efficacy of IL-1ra to treat tophaceous gout of the lumbar spine. Rheumatology 2011;50:622-4
13. Gratton SB, Scalapino KJ, Fye KH. Case of anakinra as a steroid-sparing agent for gout inflammation. Arthritis Rheum 2009;61: 1268-70
14. So A, De Smedt T, Revaz S, Tschopp J. A pilot study of IL-1 inhibition by anakinra in acute gout. Arthritis Res Ther 2007;9: R28
15. Perez-Ruiz F, Herrero-Beites A, Alonso-Ruiz A, et al. Low-dose anakinra is effective for the prophylaxis of acute episodes of inflammation in severe tophaceous gout. Ann Rheum Dis 2013; 72(Suppl 3):70
16. Terkeltaub R, Sundy JS, Schumacher HR, et al. The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study. Ann Rheum Dis 2009;68:1613-17
17. Schumacher HR, Sundy JS, Terkeltaub R, et al. Rilonacept (interleukin-1 Trap) in the prevention of acute gout flares during initiation of urate-lowering therapy. Results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2012;64:876-84
18. Terkeltaub RA, Schumacher HR, Carter JD, et al. Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator. Arthritis Res Ther 2013;15:R25
19. Schumacher HR, Evans RR, Saag KG, et al. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken) 2012;64:1462-70
20. Mitha E, Schumacher HR, Fouche L, et al. Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial. Rheumatology (Oxford) 2013;52:1285-92
21. EMA. Canakinumab summary of product characteristics WC500031680. 2013. Available from: www.ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
22. Committee for Medicinal Products for Human Use (CHMP). Summary of opinion (post authorisation). Ilaris-canakinumab. 2013. Available from: www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion/human/001109/ WC500146596.pdf
23. Committee for Orphan Medicinal Products. Public summary of opinion on orphan designation. Canakinumab for the treatment of tumour necrosis factor receptor-associated periodic syndrome. 2012. Available from: www.ema.europa.eu/docs/en-GB/document-library/Orphan-designation/2012/12/ WC500136400.pdf
24. Dhimolea E. Canakinumab. mAbs 2010;2: 3-13
25. Chakraborty A, Tannenbaum S, Rordorf C, et al. Pharmacokinetic and pharmacodynamic properties of canakinumab, a human anti-interleukin-1b monoclonal antibody. Clin Pharmacokinet 2012;51:e1-e18
26. Patent application. Canakinumab. WO02/16436. 2002.www.patentlens.net/ imageserver/getimage/WO-2002-016436-A2.pdf;jsessionid= C3734E3E0EA2E634768B146384A57A45?id=14041082&page=all.
27. Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 2008;84:548-58
28. Schlesinger N, Mysler E, Lin HY, et al. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study. Ann Rheum Dis 2011;70:1264-71
29. So A, De MM, Pikhlak A, et al. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: results of a multicenter, phase II, dose-ranging study. Arthritis Rheum 2010;62:3064-76
30. Schlesinger N, Alten R, Bardin T, et al. Canakinumab for acute gouty arthritis in patients with limited treatment options: results from two randomised, multicentre, active-controlled, double-blind trials and their initial extensions. Ann Rheum Dis 2012;71:1839-48
31. Janssens HJEM, Lucassen PLBJ, van de Laar FA, Van de Lisdonk EH. Systemic corticosteroids for acute gout. Cochrane Database Syst Rev 2008. [Epub ahead of print]
32. Janssens HJ, Janssen M, van de Lisdonk EH, et al. Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial. Lancet 2008;371:1854-60