Pegloticase, a polyethylene glycol conjugate of uricase for the potential intravenous treatment of gout

Current Opinion in Investigational Drugs

Volumn 9, Issue 4, 2008, Pages 422-429

  Biggers, K ^a   Scheinfeld, N ^b  

^a WEST VIRGINIA UNIVERSITY   (United States)

^b St Lukes Roosevelt Hospital Center ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGOUT AGENT; PEGLOTICASE; SUPEROXIDE DISMUTASE MACROGOL; UNCLASSIFIED DRUG; URATE OXIDASE;

ARTHRALGIA; BACKACHE; BLOOD PRESSURE; CLINICAL TRIAL; DIARRHEA; DIZZINESS; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG SYNTHESIS; DRUG WITHDRAWAL; DYSPEPSIA; ENZYME ACTIVITY; FLUSHING; GOUT; HUMAN; INJECTION SITE PAIN; INJECTION SITE SWELLING; INSOMNIA; MUSCLE CRAMP; NONHUMAN; REVIEW; SIDE EFFECT; SKIN MANIFESTATION; SWEATING; THORAX PAIN; UPPER RESPIRATORY TRACT INFECTION;

ANIMALS; DELAYED-ACTION PREPARATIONS; DRUG EVALUATION, PRECLINICAL; GOUT; GOUT SUPPRESSANTS; HUMANS; INJECTIONS, INTRAVENOUS; MOLECULAR STRUCTURE; PATENTS AS TOPIC; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; STRUCTURE-ACTIVITY RELATIONSHIP; TREATMENT OUTCOME; URATE OXIDASE;

EID: 41949098852     PISSN: 14724472     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (64)

1. 294947 Bio-Technology General acquires rights to technology for important new drug, PEG-uricase, from Duke University and Mountain View Pharmaceuticals Inc. Bio Technology General Corp PRESS RELEASE 1998 August 17
2. 491134 Phase I study of uricase formulated with polyethylene glycol (Uricase-PEG 20). Bomalaski JS, Goddard DH, Grezlak D, Lopatin MA, Holtsberg FW, Ensor CM, Clark MA ARTHRITIS AND RHEUMATISM 2002 46 9 Suppl Abs 287
3. 565255 A phase I study of PEGylated-uricase (puricase) in subjects with gout. Sundy JS, Ganson N, Kelly SJ, Scarlett EL, Hershfield MS ARTHRITIS RHEUM 2004 50 9 Suppl Abs 807
4. 565256 Antibodies to polyethylene glycol (PEG) during phase I investigation of PEG-urate oxidase (PEG-uricase; puricase) for refractory gout. Ganson N, Kelly SJ, Scarlett EL, Sundy JS, Hershfield MS ARTHRITIS RHEUM 2004 50 9 Suppl Abs 808
5. 579493 Diabetes insipidus in uricase-deficient mice: A model for evaluating therapy with poly(ethylene glycol)-modified uricase. Kelly SJ, Delnomdedieu M, Oliverio MI, Williams LD, Saifer MG, Sherman MR, Coffman TM, Johnson GA, Hershfield MS J AM SOC NEPHROL 2001 12 5 1001-1009
6. 579495 Studies on antigenicity of the polyethylene glycol (PEG)-modified uricase. Tsuji J, Hirose K, Kasahara E, Naitoh M, Yamamoto I INT J IMMUNOPHARMACOL 1985 7 5 725-730
7. 601095 Savient determines phase III optimum dose for gout drug. Savient Pharmaceuticals Inc PRESS RELEASE 2005 May 12
8. 623111 The management of gout. Emmerson BT N ENGL J MED 1996 334 7 445-451
9. 623112 Treatment of chronic gout: Can we determine when urate stores are depleted enough to prevent attacks of gout? Li-Yu J, Clayburne G, Sieck M, Beutler A, Rull M, Eisner E, Schumacher HR Jr J RHEUMATOL 2001 28 3 577-580
10. 637281 Induction of tolerance in mice by uricase and monomethoxypolyethylene glycol-modified uricase. Savoca KV, Davis FF, Palczuk NC INT ARCH ALLERGY APPL IMMUNOL 1984 75 1 58-67
11. 650379 Serum uric acid-lowering therapies: Where are we heading in management of hyperuricemia and the potential role of uricase. Bomalaski JS, Clark MA CURR RHEUMATOLOGY REP 2004 6 3 240-247
12. 651056 Savient to sell Rosemont to raise cash for puricase and share buyback. Savient Pharmaceuticals Inc PRESS RELEASE 2006 February 20
13. 657042 FDA approves Savient's phase III gout program for puricase. Savient Pharmaceuticals Inc PRESS RELEASE 2006 March 21
14. 665502 Savient receives FDA final approval for puricase (PE-Guricase) phase 3 special protocol assessment (SPA): Patient dosing to begin in May. Savient Pharmaceuticals Inc PRESS RELEASE 2006 May 03
15. 673789 Savient's puricase enters phase III for gout. Savient Pharmaceuticals Inc PRESS RELEASE 2006 June 15
16. 675251 Savient's puricase (PEG-uricase) phase 2 results show powerful anti-hyperuricemic activity in treatment-failure gout patients. Savient Pharmaceuticals Inc PRESS RELEASE 2006 June 22
17. 720869 Ipsen: EMEA's validation of Febuxostat's Marketing Authorization Application in the European Union. Ipsen PRESS RELEASE 2006 October 02
18. 743263 Resolution of tophi with intravenous PEG-uricase in refractory gout. Baraf HSB, Kim S, Matsumoto AK, Maroli AN ARTHRITIS RHEUM 2005 52 9 S105
19. 743264 A phase 2 study of multiple doses of intravenous polyethylene glycol (PEG)-uricase in patients with hyperuricemia and refractory gout. Sundy JS, Becker MA, Baraf HSB, Barkhuizen A, Moreland L, Huang B, Alton M ARTHRITIS RHEUM 2005 52 9 S680
20. 771516 Savient completes enrollment in puricase phase III gout trials. Savient Pharmaceuticals Inc PRESS RELEASE 2007 March 06
21. 786555 Pharmacokinetics and pharmacodynamics of intravenous PEGylated recombinant mammalian urate oxidase in patients with refractory gout. Sundy JS, Ganson NJ, Kelly SJ, Scarlett EL, Rehrig CD, Huang W, Hershfield MS ARTHRITIS RHEUM 2007 56 3 1021-1028
22. 791685 Savient Pharmaceuticals reports first quarter 2007 financial results. Savient Pharmaceuticals Inc PRESS RELEASE 2007 May 07
23. 797050 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. Ganson NJ, Kelly SJ, Scarlett E, Sundy JS, Hershfield MS ARTHRITIS RES THER 2006 8 1 R12
24. 832870 A phase 2 study of multiple doses of intravenous polyethylene glycol (PEG)-uricase in patients with hyperuricemia and treatment-failure gout Sundy JS, Becker MA, Baraf HSB , Barkhuizen A, Moreland LW, Huang B, Alton M ANN RHEUM DIS 2006 65 Suppl 2 THU0516
25. 832873 Resolution of tophi with intravenous peg-uricase in treatment-failure gout. Baraf HSB, Kim S, Matsumoto AK, Maroli AN ANN RHEUM DIS 2006 65 Suppl 2 THU0465
26. 832877 Pharmacokinetics and pharmacodynamics of PEG-uricase in patients with hyperuricemia and treatment-failure gout. Waltrip RW, Rosario-Jansen T, Seng Yue CB, Marier J, Huang B, Alton M, Maroli AN, Wright DE, Di Marco M ANN RHEUM DIS 2007 66 Suppl 2 THU0358
27. 840235 Savient completes in-life portion of puricase phase III gout trials. Savient Pharmaceuticals Inc PRESS RELEASE 2007 October 16
28. 860799 Savient's puricase effective in phase III gout trials. Savient Pharmaceuticals Inc PRESS RELEASE 2007 December 13
29. 871165 Urate-lowering pharmacotherapy with febuxostat (FEB) or allopurinol (ALLO) in African-American subjects with gout. Becker MA, MacDonald PA, Lloyd EJ, Lademacher C, Joseph-Ridge N ARTHRITIS AND RHEUMATISM 2007 56 9 Suppl 2 S637
30. 871326 Urate-lowering therapy febuxostat (FEB) or allopurinol (ALLO) in subjects with gout: Interim results from the febuxostat comparative extension long-term study (EXCEL). Becker MA, Schumacher HR Jr, MacDonald PA, Lloyd EJ, Lademacher C, Joseph-Ridge N ARTHRITIS AND RHEUMATISM 2007 56 9 Suppl 2 S322
31. 872109 A concise history of gout and hyperuricemia and their treatment. Nuki G, Simkin PA ARTHRITIS RES THER 2006 8 Suppl 1 S1
32. 872112 Archeology in medicine: Digging up into the tophi of popes, dukes and kings. Ceccarelli G RHEUMATISMO 2003 55 2 123-130
33. 872114 Increasing prevalence of gout and hyperuricemia over 10 years among older adults in a managed care population. Wallace KL, Riedel AA, Joseph-Ridge N, Wortmann R J RHEUMATOL 2004 31 8 1582-1587
34. 872115 Quality of care indicators for gout management. Mikuls TR, MacLean CH, Olivieri J, Patino F, Allison JJ, Farrar JT, Bilker WB, Saag KG ARTHRITIS RHEUM 2004 50 3 937-943
35. 872128 Pathophysiology, clinical presentation and treatment of gout. Teng GG, Nair R, Saag KG DRUGS 2006 66 12 1547-1563
36. 872130 Uric acid, hominoid evolution and the pathogenesis of saltsensitivity. Watanabe S, Kang DH, Feng L, Nakagawa T, Kanellis J, Lan H, Mazzali M, Johnson RJ HYPERTENSION 2002 40 3 355-360
37. 872138 Effect of urate-lowering therapy on the velocity of size reduction of tophi in chronic gout. Perez-Ruiz F, Calabozo M, Pijoan JI, Herrero-Beites AM, Ruibal A ARTHRITIS RHEUM 2002 47 4 356-360
38. 872142 Synovial fluid analysis for diagnosis of intercritical gout. Pascual E, Batlle-Gualda E, Martínez A, Rosas J, Vela P ANN INTERN MED 1999 131 10 756-759
39. 872145 Time required for disappearance of urate crystals from synovial fluid after successful hypouricaemic treatment relates to the duration of gout. Pascual E, Sivera F ANN RHEUM DIS 2007 66 8 1056-1058
40. 872151 Fatal allopurinol hypersensitivity syndrome after treatment of asymptomatic hyperuricaemia. Gutierrez-Macías A, Lizarralde-Palacios E, Martínez-Odriozola P, Miguel-De la Villa F BMJ 2005 331 7517 623-624
41. 872152 Treatment of chronic gout in patients with renal function impairment. An open, randomized, actively controlled study. Perez-Ruiz F, Calabozo M, Fernandez-Lopez JM, Herrero-Beites A, Ruiz-Lucea E, Garcia-Erauskin G, Duruelo J, Alonso-Ruiz A J CLIN RHEUMATOL 1999 5 49-55
42. 872181 Benzbromarone withdrawn from the European market: Another case of "absence of evidence is evidence of absence"? Jansen TL, Reinders MK, van Roon EN, Brouwers JR CLIN EXP RHEUMATOL 2004 22 5 651
43. 872200 Elitek-rasburicase: An effective means to prevent and treat hyperuricemia associated with tumor lysis syndrome, a meeting report, Dallas, Texas, January 2002. Navolanic PM, Pui CH, Larson RA, Bishop MR, Pearce TE, Cairo MS, Goldman SC, Jeha SC, Shanholtz CB, Leonard JP, McCubrey JA LEUKEMIA 2003 17 3 499-514
44. 872217 Efficacy and safety of rasburicase (recombinant urate oxidase) for the prevention and treatment of hyperuricemia during induction chemotherapy of aggressive non-Hodgkin's lymphoma: Results of the GRAAL1 (Groupe d'Etude des Lymphomes de l'Adulte Trial on Rasburicase Activity in Adult Lymphoma) study. Coiffier B, Mounier N, Bologna S, Ferme C, Tilly H, Sonet A, Christian B, Casasnovas O, Jourdan E, Belhadj K, Herbrecht R J CLIN ONCOL 2003 21 23 4402-4406
45. 872218 A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Goldman SC, Holcenberg JS, Finklestein JZ, Hutchinson R, Kreissman S, Johnson FL, Tou C, Harvey E, Morris E, Cairo MS BLOOD 2001 97 10 2998-3003
46. 872222 Rasburicase: Potential role in managing tumor lysis in patients with hematological malignancies. Goldman SC EXPERT REV ANTICANCER THER 2003 3 4 429-433
47. 872228 Rasburicase for the treatment and prevention of hyperuricemia. Yim BT, Sims-McCallum RP, Chong PH ANN PHARMACOTHER 2003 37 7-8 1047-1054
48. 872229 Emerging therapies in the long-term management of hyperuricaemia and gout. Stamp LK, O'Donnell JL, Chapman PT INT MED J 2007 37 4 258-266
49. 872238 Transformation of epithelial cells by stably transfected H2O2-generating peroxisomal urate oxidase. Chu R, Lin Y, Reddy KC, Pan J, Rao MS, Reddy JK, Yeldandi AV CANCER RES 1996 56 21 4846-4852
50. 873877 Savient reports additional positive trial data for secondary endpoints from puricase (pegloticase) phase 3 studies. Savient Pharmaceuticals Inc PRESS RELEASE 2008 February 04
51. 875146 Hyperuricemia and gout. Becker MA METAB MOL BASES INHER DIS (EDS: SCRIVER CR, BEAUDET AL, SLY WS, VALLE D) 8th Edition McGraw-Hill, New York 2001 2513-2535
52. 875149 Metabolic bone and joint disease. Clinical gout and the pathogenesis of hyperuricemia. Becker MA, Jolly M ARTHRITIS ALLIED CONDITIONS: A TEXTBOOK RHEUMATOL (EDS: KOOPMAN WJ) 15th Edition Williams and Wilkins, Baltimore 2005 2303-2339
53. 875150 Hyperuricemia and urate excretion in chronic renal disease. McPhaul J METABOLISM 1968 17 5 430-438
54. 875153 WO-00007629: PEG-urate oxidase conjugates and use thereof. Williams LD, Hershfield MS, Kelly SJ, Saifer MGP, Sherman MR WORLD PATENT 2000 February 17
55. 877822 Persistence of monosodium urate crystals and low-grade inflammation in the synovial fluid of patients with untreated gout. Pascual E ARTHRITIS RHEUM 1991 34 2 141-145
56. 877847 Treatment with colchicine decreases white cell counts in synovial fluid of asymptomatic knees that contain monosodium urate crystals. Pascual E, Castellano JA J RHEUMA TOL 1992 19 4 600-603
57. 879855 Update on colchicine and its mechanism of action. Molad Y CURR RHEUMATOLOGY REP 2002 4 3 252-256
58. 879858 Current management of gout in patients unresponsive or allergic to allopurinol. Bardin T JOINT BONE SPINE 2004 7 6 481-485
59. 879863 Diagnosis and management of gout. Underwood M BMJ (CLINICAL RES ED) 2006 332 7553 1315-1319
60. 879873 Colchicine in acute gout. Morris I, Varughese G, Mattingly P BMJ (CLINICAL RES ED) 2003 327 7426 1725-1726
61. 880083 MedMaster patient drug information: Probenecid. American Society of Health-System Pharmacists WEB SITE 2003 April 01
62. 880087 MedMaster patient drug information: Sulfinpyrazone. American Society of Health-System Pharmacists WEB SITE 2003 April 01
63. 880113 Benzbromarone: a review of its pharmacological properties and therapeutic use in gout and hyperuricaemia. Heel RC, Brogden RN, Speight TM, Avery GS DRUGS 1977 14 5 349-366
64. 881519 Savient provides further information on top line phase 3 trials results for puricase (pegloticase). Savient Pharmaceuticals Inc PRESS RELEASE 2008 February 28