Induced and pre-existing anti-polyethylene glycol antibody in a trial of every 3-week dosing of pegloticase for refractory gout, including in organ transplant recipients

Arthritis Research and Therapy

Volumn 16, Issue 2, 2014, Pages

  Hershfield, Michael S ^a   Ganson, Nancy J ^a   Kelly, Susan J ^a   Scarlett, Edna L ^a   Jaggers, Denise A ^a   Sundy, John S ^a,b,c  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c DUKE NUS MEDICAL SCHOOL   (Singapore)

Author keywords

[No Author keywords available]

Indexed keywords

ADRENALIN; ANTIBODY; AZATHIOPRINE; COLCHICINE; CYCLOSPORIN; DIPHENHYDRAMINE; FEXOFENADINE; HYDROCORTISONE; IMMUNOGLOBULIN G ANTIBODY; INFUSION FLUID; MACROGOL; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PARACETAMOL; PEGLOTICASE; POLYETHYLENE GLYCOL ANTIBODY; PREDNISONE; TACROLIMUS; UNCLASSIFIED DRUG; URATE; URATE OXIDASE; ANTIBODIES; GOUT SUPPRESSANTS; POLYETHYLENE GLYCOLS; DRUG ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; MYCOPHENOLATE MOFETIL;

ADULT; AGED; ANTIBODY RESPONSE; AREA UNDER THE CURVE; ARTICLE; CHEST TIGHTNESS; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; ENZYME ACTIVITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FAINTNESS; FEMALE; FOLLOW UP; GOUT; GRAFT RECIPIENT; GRAFT REJECTION; HEALTH ASSESSMENT QUESTIONNAIRE; HOT FLUSH; HUMAN; HYPERURICEMIA; HYPOTENSION; HYPOXEMIA; IMMUNE RESPONSE; IMMUNOSUPPRESSIVE TREATMENT; INTRAVENOUS ADMINISTRATION; JOINT SWELLING; KIDNEY TRANSPLANTATION; LIMIT OF QUANTITATION; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; MORNING DOSAGE; NAUSEA; OPEN STUDY; PANCREAS TRANSPLANTATION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRURITUS; RASH; RECURRENT DISEASE; REFRACTORY GOUT; SIDE EFFECT; TACHYCARDIA; TIME TO MAXIMUM PLASMA CONCENTRATION; URIC ACID BLOOD LEVEL; URTICARIA; AGED, 80 AND OVER; BLOOD; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOLOGY; PHASE 2 CLINICAL TRIAL; TRANSPLANT RECIPIENTS; TREATMENT OUTCOME; ANTIBODY TITER; CONTROLLED STUDY; DRUG EFFICACY; DRUG WITHDRAWAL; INFUSION RELATED REACTION; KIDNEY PANCREAS TRANSPLANTATION; MINIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; ORGAN TRANSPLANTATION; PHARMACODYNAMICS; PLASMA HALF LIFE; UNSPECIFIED SIDE EFFECT;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; GOUT; GOUT SUPPRESSANTS; HUMANS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; TRANSPLANT RECIPIENTS; TREATMENT OUTCOME; URATE OXIDASE;

EID: 84899494083     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/ar4500     Document Type: Article

References (22)

1. Becker MA, Schumacher HR, Benjamin KL, Gorevic P, Greenwald M, Fessel J, Edwards L, Kawata AK, Frank L, Waltrip R, Huang B, Sundy JS, Gout Natural History Study Group Quality of life and disability in patients with treatment-failure gout. J Rheumatol 2009, 36:1041-1048. 10.3899/jrheum.071229, 19332629, Gout Natural History Study Group.
2. Chao J, Terkeltaub R. A critical reappraisal of allopurinol dosing, safety, and efficacy for hyperuricemia in gout. Curr Rheumatol Rep 2009, 11:135-140. 10.1007/s11926-009-0019-z, 19296886.
3. Sarawate CA, Brewer KK, Yang W, Patel PA, Schumacher HR, Saag KG, Bakst AW. Gout medication treatment patterns and adherence to standards of care from a managed care perspective. Mayo Clin Proc 2006, 81:925-934. 10.4065/81.7.925, 16835972.
4. Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, White WB, Lipsky PE, Horowitz Z, Huang W, Maroli AN, Waltrip RW, Hamburger SA, Becker MA. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA 2011, 306:711-720.
5. Krystexxa Prescribing Information NDC#54396-801-01. http://krystexxa.com/pdfs/KRYSTEXXA_Prescribing_Information.pdf.
6. Sundy JS, Ganson NJ, Kelly SJ, Scarlett E, Rehrig CD, Huang W, Hershfield MS. Pharmacokinetics and pharmacodynamics of intravenous PEGylated recombinant mammalian urate oxidase in patients with refractory gout. Arthritis Rheum 2007, 56:1021-1028. 10.1002/art.22403, 17328081.
7. Hershfield MS, Roberts LJ, Ganson NJ, Kelly SJ, Santisteban I, Scarlett E, Jaggers D, Sundy JS. Treating gout with pegloticase, a PEGylated urate oxidase, provides insight into the importance of uric acid as an antioxidant in vivo. Proc Natl Acad Sci U S A 2010, 107:14351-14356. 10.1073/pnas.1001072107, 2922538, 20660758.
8. Ganson NJ, Kelly SJ, Scarlett E, Sundy JS, Hershfield MS. 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:R12. 10.1186/ar1861, 1526556, 16356199.
9. Harris JM, Chess RB. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov 2003, 2:214-221. 10.1038/nrd1033, 12612647.
10. McDonnell T, Ioannou Y, Rahman A. PEGylated drugs in rheumatology - why develop them and do they work?. Rheumatology (Oxford) 2014, 53:391-396. 10.1093/rheumatology/ket278, 3930883, 23962623.
11. Schellekens H, Hennink WE, Brinks V. The immunogenicity of polyethylene glycol: facts and fiction. Pharm Res 2013, 30:1729-1734. 10.1007/s11095-013-1067-7, 23673554.
12. Stamp L, Searle M, O'Donnell J, Chapman P. Gout in solid organ transplantation: a challenging clinical problem. Drugs 2005, 65:2593-2611. 10.2165/00003495-200565180-00004, 16392875.
13. Sundy JS, Becker MA, Baraf HS, Barkuizen A, Moreland LW, Huang W, Waltrip RW, Maroli AN, Horowitz Z, Pegloticase Phase 2 Study Investigators Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout. Arthritis Rheum 2008, 58:2882-2891. 10.1002/art.23810, 18759308, Pegloticase Phase 2 Study Investigators.
14. Yue CS, Huang W, Alton M, Maroli AN, Waltrip RW, Wright D, Marco MD. Population pharmacokinetic and pharmacodynamic analysis of pegloticase in subjects with hyperuricemia and treatment-failure gout. J Clin Pharmacol 2008, 48:708-718. 10.1177/0091270008317589, 18420531.
15. Becker MA, Baraf HS, Yood RA, Dillon A, Vazquez-Mellado J, Ottery FD, Khanna D, Sundy JS. Long-term safety of pegloticase in chronic gout refractory to conventional treatment. Ann Rheum Dis 2013, 72:1469-1474. 10.1136/annrheumdis-2012-201795, 3756467, 23144450.
16. Sherman MR, Williams LD, Sobczyk MA, Michaels SJ, Saifer MG. Role of the methoxy group in immune responses to mPEG-protein conjugates. Bioconjug Chem 2012, 23:485-499. 10.1021/bc200551b, 3309606, 22332808.
17. Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation 2007, 116:894-900. 10.1161/CIRCULATIONAHA.107.703389, 17698728.
18. Krishnan E, Svendsen K, Neaton JD, Grandits G, Kuller LH. Long-term cardiovascular mortality among middle-aged men with gout. Arch Intern Med 2008, 168:1104-1110. 10.1001/archinte.168.10.1104, 18504339.
19. Stack AG, Hanley A, Casserly LF, Cronin CJ, Abdalla AA, Kiernan TJ, Murthy BV, Hegarty A, Hannigan A, Nguyen HT. Independent and conjoint associations of gout and hyperuricaemia with total and cardiovascular mortality. QJM 2013, 106:647-658. 10.1093/qjmed/hct083, 23564632.
20. Strasak A, Ruttmann E, Brant L, Kelleher C, Klenk J, Concin H, Diem G, Pfeiffer K, Ulmer H. Serum uric acid and risk of cardiovascular mortality: a prospective long-term study of 83,683 Austrian men. Clin Chem 2008, 54:273-284. 10.1373/clinchem.2007.094425, 18039719.
21. Strasak AM, Kelleher CC, Brant LJ, Rapp K, Ruttmann E, Concin H, Diem G, Pfeiffer KP, Ulmer H. Serum uric acid is an independent predictor for all major forms of cardiovascular death in 28,613 elderly women: a prospective 21-year follow-up study. Int J Cardiol 2008, 125:232-239. 10.1016/j.ijcard.2007.11.094, 18237790.
22. Perez-Ruiz F, Martínez-Indart L, Carmona L, Herrero-Beites AM, Pijoan JI, Krishnan E. Tophaceous gout and high level of hyperuricaemia are both associated with increased risk of mortality in patients with gout. Ann Rheum Dis 2013, 73:177-182.