Pegloticase for treating refractory chronic gout

Drugs of Today

Volumn 48, Issue 7, 2012, Pages 441-449

  George, R L ^a   Sundy, J S ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Gout; Pegloticase; Quality of life; Tophus; Urate lowering therapy

Indexed keywords

PEGLOTICASE; URATE;

ANGIONEUROTIC EDEMA; ARTICLE; BACKACHE; BLOOD PRESSURE; CHEST TIGHTNESS; DISEASE EXACERBATION; DRUG APPROVAL; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FUNCTIONAL STATUS; GOUT; GOUT FLARE; HUMAN; HYPERURICEMIA; IMMUNOGENICITY; NONHUMAN; QUALITY OF LIFE; SIDE EFFECT; URIC ACID BLOOD LEVEL; URTICARIA;

EID: 84864806415     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2012.48.7.1813475     Document Type: Article

References (40)

1. Dalbeth, N., So, A. Hyperuricaemia and gout: state of the art and future perspectives. Ann Rheum Dis 2010, 69(10): 1738-43.
2. Zhu, Y., Pandya, B.J., Choi, H.K. Prevalence of gout and hyperuricemia in the US general population: the National Health and Nutrition Examination Survey 2007-2008. Arthritis Rheum 2011, 63(10): 3136-41.
3. Wallace, K.L., Riedel, A.A., Joseph-Ridge, N., Wortmann, R. Increasing prevalence of gout and hyperuricemia over 10 years among older adults in a managed care population. J Rheumatol 2004, 31(8): 1582-7. (Pubitemid 39006641)
4. Arromdee, E., Michet, C.J., Crowson, C.S., O'Fallon, W.M., Gabriel, S.E. Epidemiology of gout: is the incidence rising? J Rheumatol 2002, 29(11): 2403-6. (Pubitemid 35266034)
5. Miao, Z., Li, C., Chen, Y. et al. Dietary and lifestyle changes associated with high prevalence of hyperuricemia and gout in the Shandong coastal cities of Eastern China. J Rheumatol 2008, 35(9): 1859-64.
6. Roddy, E., Zhang, W., Doherty, M. Concordance of the management of chronic gout in a UK primary-care population with the EULAR gout recommendations. Ann Rheum Dis 2007, 66(10): 1311-5. (Pubitemid 47492473)
7. Krishnan, E., Lienesch, D., Kwoh, C.K. Gout in ambulatory care settings in the United States. J Rheumatol 2008, 35(3): 498-501. (Pubitemid 351374428)
8. Fels, E., Sundy, J.S. Refractory gout: what is it and what to do about it? Curr Opin Rheumatol 2008, 20(2): 198-202. (Pubitemid 351339893)
9. Lawrence, R.C., Felson, D.T., Helmick, C.G. et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum 2008, 58(1): 26-35.
10. Wu, E.Q., Forsythe, A., Guerin, A., Yu, A.P., Latremouille-Viau, D., Tsaneva, M. Comorbidity burden, healthcare resource utilization, and costs in chronic gout patients refractory to conventional urate-lowering therapy. Am J Ther 2011: Advance publication.
11. Becker, M.A., Schumacher, H.R., Benjamin, K.L. et al. Quality of life and disability in patients with treatment-failure gout. J Rheumatol 2009, 36(5): 1041-8.
12. Sherman, M.R., Saifer, M.G., Perez-Ruiz, F. PEG-uricase in the management of treatment-resistant gout and hyperuricemia. Adv Drug Deliv Rev 2008, 60(1): 59-68. (Pubitemid 350186186)
13. London, M., Hudson, P.B. Uricolytic activity of purified uricase in two human beings. Science 1957, 125(3254): 937-8.
14. Pui, C.H., Relling, M.V., Lascombes, F. et al. Urate oxidase in prevention and treatment of hyperuricemia associated with lymphoid malignancies. Leukemia 1997, 11(11): 1813-6. (Pubitemid 27485123)
15. Zalipsky, S., Harris, J.M. Introduction to chemistry and biological applications of poly(ethylene glycol). In: ACS Symposium Series. Vol. 680. Poly(ethylene glycol). American Chemical Society: 1997, 1-13.
16. Kelly, S.J., Delnomdedieu, M., Oliverio, M.I. et al. Diabetes insipidus in uricase-deficient mice: a model for evaluating therapy with poly(ethylene glycol)-modified uricase. J Am Soc Nephrol 2001, 12(5): 1001-9. (Pubitemid 32378341)
17. Abuchowski, A., McCoy, J.R., Palczuk, N.C., van Es, T., Davis, F.F. Effect of covalent attachment of polyethylene glycol on immunogenicity and circulating life of bovine liver catalase. J Biol Chem 1977, 252(11): 3582-6. (Pubitemid 8116088)
18. Harris, J.M., Chess, R.B. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov 2003, 2(3): 214-21. (Pubitemid 37361666)
19. Veronese, F.M., Harris, J.M. Introduction and overview of peptide and protein pegylation. Adv Drug Deliv Rev 2002, 54(4): 453-6. (Pubitemid 34615541)
20. KRYSTEXXA™ (pegloticase) for intravenous infusion, BLA No. 125293. Briefing Document for Arthritis Advisory Committee. http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ ArthritisDrugsAdvisoryCommittee/UCM165814.pdf. Accessed April 15, 2012.
21. Sundy, J.S., Baraf, H.S., Yood, R.A. et al. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA 2011, 306(7): 711-20.
22. Ganson, N.J., Kelly, S.J., Scarlett, E., Sundy, J.S., Hershfield, M.S. Control of hyperuricemia in subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG), in a phase I trial of subcutaneous PEGylated urate oxidase. Arthritis Res Ther 2006, 8(1): R12.
23. Sundy, J.S., Becker, M.A., Baraf, H.S. et al. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. Arthritis Rheum 2008, 58(9): 2882-91.
24. Sundy, J.S., Ganson, N.J., Kelly, S.J., Scarlett, E.L., Rehrig, C.D., Huang, W., Hershfield, M.S. Pharmacokinetics and pharmacodynamics of intravenous PEGylated recombinant mammalian urate oxidase in patients with refractory gout. Arthritis Rheum 2007, 56(3): 1021-8. (Pubitemid 46399452)
25. Rasburicase™ Prescribing Information . http://products.sanofi.us/ elitek/elitek.html. Accessed April 15, 2012.
26. Browning, L.A., Kruse, J.A. Hemolysis and methemoglobinemia secondary to rasburicase administration. Ann Pharmacother 2005, 39(11): 1932-5. (Pubitemid 41527709)
27. Becker, M.A., Ruoff, G.E. What do I need to know about gout? J Fam Pract 2010, 59(6, Suppl.): S1-8.
28. Becker, M.A., Schumacher, H.R., Jr., Wortmann, R.L. et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005, 353(23): 2450-61. (Pubitemid 41781828)
29. Sampson, H.A., Munoz-Furlong, A., Campbell, R.L. et al. Second symposium on the definition and management of anaphylaxis: summary report-second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. Ann Emerg Med 2006, 47(4): 373-80.
30. KrystexxaTM Prescribing Information. http://krystexxa.com/pdfs/KRYSTEXXA- Prescribing-Information.pdf. Accessed April 15, 2012.
31. Shah, A., Keenan, R.T. Gout, hyperuricemia, and the risk of cardiovascular disease: cause and effect? Curr Rheumatol Rep 2010, 12(2): 118-24.
32. Krystexxa™ Risk Evaluation and Mitigation Strategy. http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM227955.pdf. Accessed April 15, 2012.
33. Savient announces named patient programme for Krystexxa(R) in the European Union for patients with refractory chronic gout [news release]. Savient Pharmaceuticals, March 5, 2012. Accessed July 6, 2012.
34. Savient Pharmaceuticals Marketing Authorization Application for Krystexxa® accepted for review by European Medicines Agency [news release]. May 26, 2011. Accessed July 6, 2012.
35. Schlesinger, N., De Meulemeester, M., Pikhlak, A. et al. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study. Arthritis Res Ther 2011, 13(2): R53.
36. Schlesinger, N., Mysler, E., Lin, H.Y. 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(7): 1264-71.
37. Schumacher, H.R., Jr., Sundy, J.S., 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(3): 876-84.
38. So, A., De Meulemeester, M., 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(10): 3064-76.
39. 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(2): R28.
40. Terkeltaub, R., Sundy, J.S., Schumacher, H.R. 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(10): 1613-7.