Tumor necrosis factor α blockers and malignancy in children: Forty-eight cases reported to the food and drug administration

Arthritis and Rheumatism

Volumn 62, Issue 8, 2010, Pages 2517-2524

  Diak, Peter ^a   Siegel, Jeffrey ^a   La Grenade, Lois ^a   Choi, Lauren ^a   Lemery, Steven ^a   McMahon, Ann ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; ETANERCEPT; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; MERCAPTOPURINE; METHOTREXATE; PREDNISONE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; TUMOR NECROSIS FACTOR ALPHA INHIBITOR;

ADOLESCENT; ADULT; ANKYLOSING SPONDYLITIS; ARTICLE; CHILD; CLINICAL ARTICLE; CROHN DISEASE; FEMALE; FOOD AND DRUG ADMINISTRATION; HEMATOLOGIC MALIGNANCY; HODGKIN DISEASE; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFANT; JUVENILE RHEUMATOID ARTHRITIS; LEUKEMIA; LYMPHOMA; MALE; MELANOMA; NONHODGKIN LYMPHOMA; PRESCHOOL CHILD; PRIORITY JOURNAL; PSORIATIC ARTHRITIS; SCHOOL CHILD; SOLID TUMOR; ULCERATIVE COLITIS;

ADOLESCENT; ANTIBODIES, MONOCLONAL; ARTHRITIS, JUVENILE RHEUMATOID; CHILD; CHILD, PRESCHOOL; HUMANS; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENTS; INFANT; NEOPLASMS; RECEPTORS, TUMOR NECROSIS FACTOR; RISK; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77955371398     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.27511     Document Type: Article

References (30)

1. Food and Drug Administration. Early communication about an ongoing safety review of Tumor Necrosis Factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, and Cimzia). URL: www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm070725.htm.
2. Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med 2001;344:907-16.
3. Locksley RM, Killeen N, Lenardo MJ. The TNF and TNF receptor superfamilies: integrating mammalian biology. Cell 2001;104:487-501. (Pubitemid 32201945)
4. Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, et al, for the Crohn's Disease cA2 Study Group. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn's disease. N Engl J Med 1997;337:1029-35.
5. Food and Drug Administration. Drugs@FDA. Infliximab, etanercept, and adalimumab label information. URL: www.accessdata. fda.gov/scripts/cder/ drugsatfda/index.cfm.
6. Rennard SI, Fogarty C, Kelsen S, Long W, Ramsdell J, Allison J, et al, on behalf of the COPD Investigators. The safety and efficacy of infliximab in moderate to severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2007;175:926-34.
7. Stone JH, Holbrook JT, Marriott MA, Tibbs AK, Sejismundo LP, Min YI, et al, for the Wegener's Granulomatosis Etanercept Trial Research Group. Solid malignancies among patients in the Wegener's Granulomatosis Etanercept Trial. Arthritis Rheum 2006;54:1608-18.
8. Bernatsky S, Rosenberg A, Oen KG, Ramsey-Goldman R, St. Pierre Y, Turnbull E, et al. Malignancy in juvenile idiopathic arthritis [abstract]. Arthritis Rheum 2009;60 Suppl:S91-2.
9. Kayton ML. Cancer and pediatric inflammatory bowel disease. Semin Pediatr Surg 2007;16:205-13.
10. Bernstein CN, Blanchard JF, Kliewer E, Wajda A. Cancer risk in patients with inflammatory bowel disease: a population-based study. Cancer 2001;91:854-62. (Pubitemid 32173312)
11. Food and Drug Administration. Adverse Event Reporting System (AERS). URL: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ AdverseDrugEffects/default.htm.
12. Drug utilization sources: Remicade - Centocor Ortho Biotech Inc. data on file; Enbrel - Amgen Inc.; Humira - IMS Health, NPA Plus, 2006-2007. Information derived by Abbott from data provided by Wolters Kluwer Health, Source Lx, 2006-2007.
13. Smyth MJ, Godfrey DI, Trapani JA. A fresh look at tumor immunosurveillance and immunotherapy. Nat Immunol 2001;2:293-9.
14. Stagg J, Johnstone RW, Smyth MJ. From cancer immunosurveillance to cancer immunotherapy. Immunol Rev 2007;220:82-101.
15. Larmonier N, Cathelin D, Larmonier C, Nicolas A, Merino D, Janikashvili N, et al. The inhibition of TNF-α anti-tumoral properties by blocking antibodies promotes tumor growth in a rat model. Exp Cell Res 2007;313:2345-55.
16. Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum 2002;46:3151-8.
17. Mackey AC, Green L, Liang L, Dinndorf P, Avigan M. Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for irritable bowel disease. J Pediatr Gastroenterol Nutr 2007;44:265-7.
18. Mackey AC, Green L, Leptak C, Avigan M. Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease: update. J Pediatr Gastroenterol Nutr 2009;48:386-8.
19. Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998;20 Suppl C:C40-4.
20. Begaud B, Martin K, Haramburu F, Moore N. Rates of spontaneous reporting of adverse drug reactions in France [letter]. JAMA 2002;288:1588.
21. La Grenade L, Graham DJ, Nourjah P. Underreporting of hemorrhagic stroke associated with phenylpropanolamine [letter]. JAMA 2001;286:3081.
22. McAdams M, Staffa J, Dal Pan G. Estimating the extent of reporting to FDA: a case study of statin-associated rhabdomyolysis. Pharmacoepidemiol Drug Saf 2008;17:229-39.
23. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006;29:385-96.
24. Mariette X, Cazals-Hatem D, Warszawki J, Liote F, Balandraud N, Sibilia J, and the investigators of the Club Rhumatismes et Inflammation. Lymphomas in rheumatoid arthritis patients treated with methotrexate: a 3-year prospective study in France. Blood 2002;99:3909-15.
25. Callan MF. Epstein-Barr virus, arthritis, and the development of lymphoma in arthritis patients. Curr Opin Rheumatol 2004;16:399-405. (Pubitemid 38803141)
26. Thomas E, Brewster DH, Black RJ, Macfarlane GJ. Risk of malignancy among patients with rheumatic conditions. Int J Cancer 2000;88:497-502.
27. Naz SM, Symmons DP. Mortality in established rheumatoid arthritis. Best Pract Res Clin Rheumatol 2007;21:871-83.
28. McClain KL, Leach CT, Jenson HB, Joshi VV, Pollock BH, Parmley RT, et al. Association of Epstein-Barr virus with leiomyosarcomas in children with AIDS. N Engl J Med 1995;332:12-8.
29. Chadwick EG, Connor EJ, Hanson IC, Joshi VV, Abu-Farsakh H, Yogev R, et al. Tumors of smooth-muscle origin in HIV-infected children. JAMA 1990;263:3182-4.
30. Brichard B, Smets F, Sokal E, Clapuyt P, Vermylen C, Cornu G, et al. Unusual evolution of an Epstein-Barr virus-associated leiomyosarcoma occurring after liver transplantation. Pediatr Transplant 2001;5:365-9.