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 (United Kingdom)

Volumn 52, Issue 7, 2013, Pages 1285-1292

  Mitha, Essack ^a   Ralph Schumacher, H ^b   Fouche, Leon ^c   Luo, Shue Fen ^d   Weinstein, Steven P ^e   Yancopoulos, George D ^e   Wang, Jian ^e   King Davis, Shirletta ^e   Evans, Robert R ^e  

^a Newtown Clinical Research   (South Africa)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c Limpopo Clinical Research Initiative   (South Africa)

^d CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^e REGENERON PHARMACEUTICALS INC   (United States)

Author keywords

Biologic therapies; Clinical trials and methods; Crystal arthropathies; Cytokines and inflammatory mediators; Inflammation

Indexed keywords

ALLOPURINOL; PLACEBO; RILONACEPT;

ADULT; APPENDICITIS; ARTICLE; ASIA; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GERMANY; GOUT; HUMAN; HYPERURICEMIA; INFESTATION; INFLUENZA; INJECTION SITE REACTION; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SOUTH AFRICA; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URIC ACID BLOOD LEVEL;

BIOLOGIC THERAPIES; CLINICAL TRIALS AND METHODS; CRYSTAL ARTHROPATHIES; CYTOKINES AND INFLAMMATORY MEDIATORS; INFLAMMATION;

ADULT; ALLOPURINOL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GOUT; GOUT SUPPRESSANTS; HUMANS; HYPERURICEMIA; MALE; MEDICATION ADHERENCE; MIDDLE AGED; RECEPTORS, INTERLEUKIN-1 TYPE I; RECOMBINANT FUSION PROTEINS; TREATMENT OUTCOME; URIC ACID;

EID: 84879816861     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/ket114     Document Type: Article

References (33)

1. Dalbeth N, Haskard DO. Mechanisms of inflammation in gout. Rheumatology 2005;44:1090-6.
2. Ellman MH, Becker MA. Crystal-induced arthropathies: recent investigative advances. Curr Opin Rheumatol 2006; 18:249-55.
3. Zhang W, Doherty M, Bardin T et al. EULAR evidence-based recommendations for gout. Part II. Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2006; 65:1312-24.
4. Jordan KM, Cameron JS, Snaith M et al. British Society for Rheumatology and British Health Professionals in Rheumatology guideline for the management of gout. http://rheumatology.oxfordjournals.org/content/suppl/ 2008/02/21/kem056a.DC1/kem056b.pdf (11 August 2011, date last accessed).
5. Schumacher HRJ, Chen LX. The practical management of gout. Cleve Clin J Med 2008;75(Suppl 5):S22-25.
6. Terkeltaub R, Zelman D, Scavulli J et al. Gout Study Group: update on hyperuricemia and gout. Joint Bone Spine 2009;76:444-6.
7. Liu-Bryan R, Terkeltaub R. Evil humors take their toll as innate immunity makes gouty joints TREM-ble. Arthritis Rheum 2006;54:383-6.
8. Riedel AA, Nelson M, Joseph-Ridge N et al. Compliance with allopurinol therapy among managed care enrollees with gout: a retrospective analysis of administrative claims. J Rheumatol 2004;31:1575-81.
9. Sarawate CA, Brewer KK, Yang W et al. Gout medication treatment patterns and adherence to standards of care from a managed care perspective. Mayo Clin Proc 2006; 81:925-34.
10. Sarawate CA, Patel PA, Schumacher HR et al. Serum urate levels and gout flares: analysis from managed care data. J Clin Rheumatol 2006;12:61-5.
11. Harrold LR, Andrade SE, Briesacher BA et al. Adherence with urate-lowering therapies for the treatment of gout. Arthritis Res Ther 2009;11:R46.
12. Briesacher BA, Andrade SE, Fouayzi H et al. Comparison of drug adherence rates among patients with seven different medical conditions. Pharmacotherapy 2008;28: 437-43.
13. Keenan RT, O'Brien WR, Lee KH et al. Prevalence of contraindications and prescription of pharmacologic therapies for gout. Am J Med 2011;124:155-63.
14. Martinon F, Pétrilli V, Mayor A et al. Gout-associated uric acid crystals activate the NALP3 inflammasome. Nature 2006;440:237-41.
15. Torres R, Macdonald L, Reinhardt J et al. Pain and inflammation in animal models of gout is reduced by mIL-1 TRAP. 2008.
16. So A, DeSmedt T, Revaz S et al. A pilot study of IL-1 inhibition by anakinra in acute gout. Arthritis Res Ther 2007;9:R28.
17. McGonagle D, Tan AL, Shankaranarayana S et al. Management of treatment resistant inflammation of acute on chronic tophaceous gout with anakinra. Ann Rheum Dis 2007;66:1683-4.
18. Singh D, Huston KK. IL-1 inhibition with anakinra in a patient with refractory gout. J Clin Rheumatol 2009;15:366.
19. Gratton SB, Scalapino KJ, Fye KH. Case of anakinra as a steroid-sparing agent for gout inflammation. Arthritis Rheum 2009;61:1268-70.
20. 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;62:3064-76.
21. Schumacher HR, Sundy JS, Terkeltaub R et al. Rilonacept (IL-1 Trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase 2 clinical trial. Arthritis Rheum 2011;64:876-84.
22. Economides AN, Carpenter LR, Rudge JS et al. Cytokine traps: multi-component, high-affinity blockers of cytokine action. Nat Med 2003;9:47-52.
23. Arcalyst- [rilonacept] prescribing information. Regeneron Pharmaceuticals, Inc., Tarrytown, NY, April 2010.
24. Schumacher H, Evans R, Saag K et al. Rilonacept (interleukin- 1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results of the PRESURGE-1 trial. Arthritis Care Res (Hoboken) 2012;64:1462-70.
25. Wallace SL, Robinson H, Masi AT et al. Preliminary criteria for the classification of the acute arthritis of primary gout. Arthritis Rheum 1977;20:895-900.
26. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
27. Taylor WJ, Shewchuk R, Saag KG et al. Toward a valid definition of gout flare: results of consensus exercises using Delphi methodology and cognitive mapping. Arthritis Rheum 2009;61:535-43.
28. Borstad GC, Bryant LR, Abel MP et al. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol 2004;31:2429-32.
29. Becker MA, Schumacher HRJ, Wortmann RL et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005;353:2450-61.
30. Schumacher HRJ, Becker MA, Wortmann RL et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum 2008;59:1540-8.
31. Schumacher HR, Sundy JS, Terkeltaub R et al. Placebo-controlled study of rilonacept for gout flare prophylaxis during initiation of urate-lowering therapy [abstract]. Arthritis Rheum 2009;60(Suppl 10):1096.
32. Weinstein S, Soo Y, Wang J et al. Gout flare definition: what can we learn from features that distinguish active treatment from placebo. Ann Rheum Dis 2010;69(Suppl 3):605.
33. Furst DE. The risk of infections with biologic therapies for rheumatoid arthritis. Semin Arthritis Rheum 2010;39: 327-46.