Etanercept as adjunctive treatment for acute kawasaki disease: Study design and rationale

American Heart Journal

Volumn 161, Issue 3, 2011, Pages 494-499

  Portman, Michael A ^a,e   Olson, Aaron ^a   Soriano, Brian ^a   Dahdah, Nagib ^b   Williams, Richard ^c   Kirkpatrick, Edward ^d  

^a SEATTLE CHILDREN S HOSPITAL   (United States)

^b UNIVERSITY OF MONTREAL   (Canada)

^c PRIMARY CHILDREN'S MEDICAL CENTER   (United States)

^d Children's Hospital of Wisconsin   (United States)

^e SEATTLE CHILDREN S RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETANERCEPT; IMMUNOGLOBULIN G; PLACEBO; TUMOR NECROSIS FACTOR ALPHA;

ARTICLE; CLINICAL TRIAL (TOPIC); CORONARY ARTERY; CORONARY ARTERY DILATATION; DRUG EFFICACY; DRUG SAFETY; HUMAN; MUCOCUTANEOUS LYMPH NODE SYNDROME; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RISK FACTOR; TREATMENT DURATION;

CORONARY VESSELS; DILATATION, PATHOLOGIC; ENDPOINT DETERMINATION; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC FACTORS; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTORS, TUMOR NECROSIS FACTOR; RESEARCH DESIGN;

EID: 79952377060     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2010.12.003     Document Type: Article

References (40)

1. Nakamura Y., Yashiro M., and Uehara R. Epidemiologic features of Kawasaki disease in Japan: results of the 2007-2008 nationwide survey J Epidemiol 20 2009 302 307
2. Holman R.C., Belay E.D., and Christensen K.Y. Hospitalizations for Kawasaki syndrome among children in the United States, 1997-2007 Pediatr Infect Dis J 29 2010 483 488
3. Newburger J.W., Takahashi M., and Burns J.C. The treatment of Kawasaki syndrome with intravenous gamma globulin N Engl J Med 315 1986 341 347 (Pubitemid 16060087)
4. Tremoulet A.H., Best B.M., and Song S. et al. Resistance to intravenous immunoglobulin in children with Kawasaki disease J Pediatr 153 2008 117 121
5. Wallace C.A., French J.W., and Kahn S.J. Initial intravenous gammaglobulin treatment failure in Kawasaki disease Pediatrics 105 2000 E78
6. Newburger J.W., Takahashi M., and Gerber M.A. Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association Pediatrics 114 2004 1708 1733 (Pubitemid 41754943)
7. Kato H., Koike S., and Yokoyama T. Kawasaki disease: effect of treatment on coronary artery involvement Pediatrics 63 1979 175 179 (Pubitemid 9083134)
8. Inoue Y., Okada Y., and Shinohara M. A multicenter prospective randomized trial of corticosteroids in primary therapy for Kawasaki disease: clinical course and coronary artery outcome J Pediatr 149 2006 336 341
9. Newburger J.W., Sleeper L.A., and McCrindle B.W. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease N Engl J Med 356 2007 663 675
10. Hui-Yuen J.S., Duong T.T., and Yeung R.S. TNF-alpha is necessary for induction of coronary artery inflammation and aneurysm formation in an animal model of Kawasaki disease J Immunol 176 2006 6294 6301
11. Ichiyama T., Yoshitomi T., and Nishikawa M. NF-kappaB activation in peripheral blood monocytes/macrophages and T cells during acute Kawasaki disease Clin Immunol 99 2001 373 377
12. Matsubara T., Ichiyama T., and Furukawa S. Immunological profile of peripheral blood lymphocytes and monocytes/macrophages in Kawasaki disease Clin Exp Immunol 141 2005 381 387 (Pubitemid 41075860)
13. Gupta M., Noel G.J., and Schaefer M. Cytokine modulation with immune gamma-globulin in peripheral blood of normal children and its implications in Kawasaki disease treatment J Clin Immunol 21 2001 193 199 (Pubitemid 32434306)
14. Kaneko K., Savage C.O., and Pottinger B.E. Antiendothelial cell antibodies can be cytotoxic to endothelial cells without cytokine pre-stimulation and correlate with ELISA antibody measurement in Kawasaki disease Clin Exp Immunol 98 1994 264 269 (Pubitemid 24336824)
15. Lang B.A., Silverman E.D., and Laxer R.M. Serum-soluble interleukin-2 receptor levels in Kawasaki disease J Pediatr 116 1990 592 596 (Pubitemid 20124158)
16. Furukawa S., Matsubara T., and Umezawa Y. Serum levels of p60 soluble tumor necrosis factor receptor during acute Kawasaki disease J Pediatr 124 5 Pt 1 1994 721 725 (Pubitemid 24161460)
17. Koga M., Ishihara T., and Takahashi M. Activation of peripheral blood monocytes and macrophages in Kawasaki disease: ultrastructural and immunocytochemical investigation Pathol Int 48 1998 512 517 (Pubitemid 28341087)
18. Kim D.S., and Lee K.Y. Serum soluble E-selectin levels in Kawasaki disease Scand J Rheumatol 23 1994 283 286 (Pubitemid 24334036)
19. Tracey D., Klareskog L., and Sasso E.H. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review Pharmacol Ther 2007
20. Furst D.E., Wallis R., and Broder M. Tumor necrosis factor antagonists: different kinetics and/or mechanisms of action may explain differences in the risk for developing granulomatous infection Sem Arthritis Rheum 36 2006 159 167 (Pubitemid 44691882)
21. Centocor. Infliximab (Remicade®) Prescribing Information Available at: http://www.remicade.com/pdf/HCP-PPI.pdf Last accessed January 25, 2008
22. Abbott Laboratories, Humira™ (adalimumab) Prescribing Information, Package Insert Available at: http://www.rxabbott.com/pdf/humira.pdf Last accessed Jan 25, 2008
23. Scallon B., Cai A., and Solowski N. Binding and functional comparisons of two types of tumor necrosis factor antagonists J Pharmacol Exp Ther 301 2002 418 426 (Pubitemid 34429950)
24. Santora L.C., Kaymakcalan Z., and Sakorafas P. Characterization of noncovalent complexes of recombinant human monoclonal antibody and antigen using cation exchange, size exclusion chromatography, and BIAcore Analytical Biochemistry 299 2001 119 129 (Pubitemid 34053400)
25. Moran A.M., Newburger J.W., and Sanders S.P. Abnormal myocardial mechanics in Kawasaki disease: rapid response to gamma-globulin Am Heart J 139 2 Pt 1 2000 217 223 (Pubitemid 30090797)
26. Coletta A.P., Clark A.L., and Banarjee P. Clinical trials update: RENEWAL (RENAISSANCE and RECOVER) and ATTACH Eur J Heart Fail 4 2002 559 561 (Pubitemid 36564977)
27. Gullestad L., and Aukrust P. Review of trials in chronic heart failure showing broad-spectrum anti-inflammatory approaches Am J Cardiol 95 2005 17C 23C [discussion 38C-40C] (Pubitemid 40755514)
28. Lugering A., Schmidt M., and Lugering N. Infliximab induces apoptosis in monocytes from patients with chronic active Crohn's disease by using a caspase-dependent pathway Gastroenterology 121 2001 1145 1157 (Pubitemid 33022095)
29. Weiss J.E., Eberhard B.A., and Chowdhury D. Infliximab as a novel therapy for refractory Kawasaki disease J Rheumatol 31 2004 808 810 (Pubitemid 38451274)
30. Son M.B., Gauvreau K., and Ma L. Treatment of Kawasaki disease: analysis of 27 US pediatric hospitals from 2001 to 2006 Pediatrics 124 2009 1 8
31. Burns J.C., Best B.M., and Mejias A. Infliximab treatment of intravenous immunoglobulin-resistant Kawasaki disease J Pediatr 153 2008 833 838
32. Choueiter N.F., Olson A.K., and Shen D.D. Prospective open-label trial of etanercept as adjunctive therapy for Kawasaki disease J Pediatr 2010 (in press)
33. Burns J.C., Capparelli E.V., and Brown J.A. Intravenous gamma-globulin treatment and retreatment in Kawasaki disease. US/Canadian Kawasaki Syndrome Study Group Pediatr Infect Dis J 17 1998 1144 1148 (Pubitemid 29023891)
34. Paller A.S., Siegfried E.C., and Langley R.G. Etanercept treatment for children and adolescents with plaque psoriasis N Engl J Med 358 2008 241 251
35. Newburger J.W., Takahashi M., and Beiser A.S. A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome N Engl J Med 324 1991 1633 1639
36. McCrindle B.W., Li J.S., and Minich L.L. Coronary artery involvement in children with Kawasaki disease: risk factors from analysis of serial normalized measurements Circulation 116 2007 174 179 (Pubitemid 47057523)
37. Sluysmans T., and Colan S.D. Theoretical and empirical derivation of cardiovascular allometric relationships in children J Appl Physiol 99 2005 445 457 (Pubitemid 41061136)
38. Yim D.S., Zhou H., and Buckwalter M. Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis J Clin Pharmacol 45 2005 246 256 (Pubitemid 40490422)
39. Anthony R.M., Wermeling F., and Karlsson M.C. Identification of a receptor required for the anti-inflammatory activity of IVIG Proc Natl Acad Sci U S A 105 2008 19571 19578
40. Shrestha S., Wiener H., and Wu J. Abstract 1947: functional variants in the inhibitory Fc{gamma}RIIb gene associated with Kawasaki disease susceptibility and IVIG treatment response Circulation 120 2009 S578 (18-MeetingAbstracts)