Best Practice & Research Clinical Rheumatology
Volume 20, Issue 4 , Pages 757-790 , August 2006

Problems encountered during anti-tumour necrosis factor therapy

  • Sheetal B. Desai, MD (Fellow in Rheumatology)

      Affiliations

    • Corresponding Author InformationCorresponding author. Address: Department of Rheumatology, University of California, Los Angeles, 1000 Veteran Avenue, Room 32–59, Los Angeles, CA 90095-1670, USA. Tel.: +1 310 825 7992; Fax: +1 310 206 8476.
    • ,
  • Daniel E. Furst, MD (Carl M. Pearson Professor of Rheumatology)

References 

  1. Maury E, Hochberg M, Cassell S, et al. Rheumatoid arthritis patients on TNF blockers have higher rates of infections. Arthritis and Rheumatism. 2005;52(supplement):S547–S548[abstract]
  2. Listing J, Strangfeld A, Kary S, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis and Rheumatism. 2005;52:3403–3412
  3. Salliot C, Gossec L, Ruyssen-Witrand A, et al. The risk of serious infections is higher in daily practice than in clinical trials for RA patients receiving TNF blockers: a systematic retrospective study of 707 patients. Arthritis and Rheumatism. 2005;52(supplement):S340;[abstract]
  4. Kroesens S, Widner AF, Tyndall A, Hasler P. Serious bacterial infections in patients with rheumatoid arthritis under anti-TNF therapy. Rheumatology. 2003;42:617–621
  5. Kent J, Pangan A, Spencer Green G, et al. Serious infections in patients with rheumatoid arthritis who participated in adalimumab clinical trials. Arthritis and Rheumatism. 2005;52(supplement):S548;[abstract]
  6. Keystone EC, Kavanagh AF, Sharp JT, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab in patients with active rheumatoid arthritis receiving concomitant methotrexate treatment. Arthritis and Rheumatism. 2004;50:1400–1411
  7. Dixon W, Watson K, Hyrich K, et al. The incidence of serious infections is not increased in patients with rheumatoid arthritis treated with anti-TNF drugs compared to those treated with traditional DMARDs: results from a national prospective study. Arthritis and Rheumatism. 2005;52(supplement):S738;[abstract]
  8. Jacobsen LTH, Turesson C, Gulfe A, et al. No increase in severe infections and rheumatoid arthritis patients treated with TNF blockers. Arthritis and Rheumatism. 2005;52(supplement):S341;[abstract]
  9. Flynn JL, Goldstein MM, Chan J, et al. Tumor necrosis factor-alpha is required in the protective immune response against Mycobacterium tuberculosis in mice. Immunity. 1995;2:561–572
  10. Turner J, Frank AA, Brooks JV, et al. Pentoxifylline treatment of mice with chronic pulmonary tuberculosis accelerates the development of destructive pathology. Immunology. 2001;102:248–253
  11. Senaldi G, Yin S. Corynebacterium parvum- and Mycobacterium bovis bacillus Calmette-Guerin-induced granuloma formation is inhibited in TNF receptor I (TNF-RI) knockout mice and by treatment with soluble TNF-RI. The Journal of Immunology. 1996;157:5022–5026
  12. Kindler V, Sappino AP, Grau GE, et al. The inducing role of tumor necrosis factor in the development of bactericidal granulomas during BCG infection. Cell. 1989;56:731–740
  13. Mohan VP, Scanga CA, Yu K, et al. Effects of tumor necrosis factor alpha on host immune response in chronic persistent tuberculosis: possible role for limiting pathology. Infection and Immunity. 2001;69:1847–1855
  14. Furst DE, Wallis R, Broder M & Beenhouwer DO. Tumor necrosis factor antagonists: different kinetics and/or mechanisms of action may explain differences in the risk for developing granulomatous infection. Arthritis and Rheumatism [in press].
  15. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. The New England Journal of Medicine. 2001;345:1098–1104
  16. Wolfe F, Michaud K, Anderson J, Urbansky K. Tuberculosis infection in patients with rheumatoid arthritis and the effect of infliximab therapy. Arthritis and Rheumatism. 2004;50:372–379
  17. Wallis RS, Broder MS, Wong JY, et al. Granulomatous infectious diseases associated with tumor necrosis factor antagonists. Clinical Infectious Diseases. 2004;38:1261–1265
  18. Wallis RS, Broder M, Wong J, et al. Granulomatous infections due to tumor necrosis factor blockade: correction. Clinical Infectious Diseases. 2004;39:1254–1255
  19. Schiff MH, Burmester GR, Pangan AL et al. Safety of adalimumab (Humira) in global clinical trials of patients with early vs. longstanding rheumatoid arthritis (RA). Abstract SAT0044. Presented at the Annual European Congress of Rheumatology (EULAR), Vienna, Austria, 2005.
  20. Kent JD, Pangan AL & Fitzpatrick SB. Analysis of the US postmarketing safety of adalimumab (HUMIRA) in patients with rheumatoid arthritis during the first 2 years after approval. Abstract presented at ACR, San Diego, 2005.
  21. Gomez-Reino JJ, Carmona L, Valverde VR, et al. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis and Rheumatism. 2003;48:2122–2127
  22. Askling J, Fored CM, Brandt L, et al. Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis and Rheumatism. 2005;52:1986–1992
  23. Gardam MA, Keystone EC, Menzies R, et al. Anti-tumour necrosis factor agents and tuberculosis risk: mechanisms of action and management. The Lancet infectious diseases. 2003;3:148–155
  24. Mariette X, Salmon D, Group RATIO . French guidelines for diagnosis and treating latent and active tuberculosis in patients with RA treated with TNF blockers. Annals of the Rheumatic Diseases. 2004;62:791
  25. Furst DE, Cush J, Kaufmann S, et al. Preliminary guidelines for diagnosing and treating tuberculosis in patients with rheumatoid arthritis in immunosuppressive trials or being treated with biologic agents. Annals of the Rheumatic Diseases. 2002;61:62–63
  26. Carmona L, Gomez-Reino JJ, Rodriguez-Valverde V, et al. Effectiveness of recommendations to prevent re-activation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis and Rheumatism. 2005;52:1766–1772
  27. Centers for Disease Control and Prevention . Tuberculosis associated with blocking agents against tumor necrosis factor-alpha – California, 2002–2003. MMWR. Morbidity and Mortality Weekly Report. 2004;53:683–686
  28. Coaccioli S, Di Cato L, Marioli D, et al. Impaired cutaneous cell-mediated immunity in newly diagnosed rheumatoid arthritis. Panminerva Medica. 2000;42:253–256
  29. Mow WS, Abrau-Martin MT, Papadakis KA, et al. High incidence of anergy in inflammatory bowel disease patients limits the usefulness of PPD screening before infliximab therapy. Clinical Gastroenterology and Hepatology. 2004;2:309–313
  30. Paimela L, Johansson-Stephansson EA, Koskimies S, Leirisalo-Repo M. Depressed cutaneous cell-mediated immunity in early rheumatoid arthritis. Clinical and Experimental Rheumatology. 1990;8:433–437
  31. Ponce de Leon D, Acevedo EM, Valenzuela G, et al. Inadequate response to tuberculin purified protein (PPD) in patients with rheumatoid arthritis. Study in a population with high prevalence of tuberculosis. Arthritis and Rheumatism. 2003;48:S108
  32. Pope RM, Kniker WT, Talal N, Dauphinee M. Delayed type hypersensitivity in patients with rheumatoid arthritis. The Journal of Rheumatology. 1993;20:17–20
  33. Crum NF, Lederman ER, Wallace MR. Infections associated with tumor necrosis factor antagonists. Medicine. 2005;84:291–302
  34. Lavancy D, McMahon B. Worldwide prevalence and prevention of hepatitis C. In:  Liang TJ,  Hoofnagle JH editor. Hepatitis C. San Diego: Academic Press; 2000;p. 186–201
  35. Nelson DR, Lim HL, Marousis CG, et al. Activation of tumor necrosis factor-α system in chronic hepatitis C virus infection. Digestive Diseases and Sciences. 1997;42:2487–2494
  36. Parke FA, Reveille JD. Anti-tumour necrosis factor agents for rheumatoid arthritis in the setting of chronic hepatitis C infection. Arthritis and Rheumatism. 2004;51:800–804
  37. Oniankitan O, Duvoux C, Challine D, et al. Infliximab therapy for rheumatic disease in patients with chronic hepatitis B or C. The Journal of Rheumatology. 2004;31:107–109
  38. Holtmann MH, Galle PR, Neurath MF. Treatment of patients with Crohn's disease and concomitant chronic hepatitis C with a chimeric monoclonal antibody to TNF. The American Journal of Gastroenterology. 2003;98:504–505
  39. Campbell S, Ghosh S. Infliximab therapy for Crohn's disease in the presence of chronic hepatitis C infection. European Journal of Gastroenterology & Hepatology. 2001;13:191–192
  40. Magliocco MA, Gottlieb AB. Etanercept therapy for patients with psoriatic arthritis and concurrent hepatitis C virus infection: report of 3 cases. Journal of the American Academy of Dermatology. 2004;51:580–584
  41. Khanna M, Shirodkar MA, Gottlieb AB. Etanercept therapy in patients with autoimmunity and hepatitis C. The Journal of Dermatological Treatment. 2003;14:229–232
  42. Peterson JR, Hsu FC, Simkin PA, Wener MH. Effect of tumour necrosis factor alpha antagonists on serum transaminases and viraemia in patients with rheumatoid arthritis and chronic hepatitis C infection. Annals of the Rheumatic Diseases. 2003;62:1078–1082
  43. Chandesris MO, Gayet S, Schleinitz N, et al. Infliximab in the treatment of refractory vasculitis secondary to hepatitis C-associated mixed cryoglobulinaemia. Rheumatology (Oxford). 2004;43:532–533
  44. Zein NN, Etanercept Study Group . Etanercept as an adjuvant to interferon and ribavirin in treatment-naïve patients with chronic hepatitis C virus infection: a phase 2 randomized, double-blind, placebo-controlled study. Journal of Hepatology. 2005;42:315–322
  45. Alter MJ. Epidemiology of hepatitis B in Europe and worldwide. Journal of Hepatology. 2003;39(supplement 1):S64–S69
  46. Torre D, Zeroli C, Giola M, et al. Serum levels of interleukin-1 alpha, interleukin-1 beta, interleukin-6, and tumor necrosis factor in patients with acute viral hepatitis. Clinical Infectious Diseases. 1994;18:194–198
  47. Fang JW, Shen WW, Meager A, Lau JY. Activation of the tumor necrosis factor-alpha system in the liver in chronic hepatitis B virus infection. The American Journal of Gastroenterology. 1996;91:748–753
  48. Kasahara S, Ando K, Saito K, et al. Lack or tumor necrosis factor alpha induces impaired proliferation of hepatitis B virus-specific cytotoxic T lymphocytes. Journal of Virology. 2003;77:2469–2476
  49. Anelli MG, Torres DD, Manno C, et al. Improvement of renal function and disappearance of hepatitis B virus DNA in a patient with rheumatoid arthritis and renal amyloidosis following treatment with infliximab. Arthritis and Rheumatism. 2005;52:2519–2520
  50. Ostuni P, Botsios C, Punzi L, et al. Hepatitis B reactivation in a chronic hepatitis B surface antigen carrier with rheumatoid arthritis treated with infliximab and low dose methotrexate. Annals of the Rheumatic Diseases. 2003;62:686–687
  51. Wendling D, Auge B, Bettinger D, et al. Reactivation of a latent precore mutant hepatitis B virus related chronic hepatitis during infliximab treatment for severe spondyloarthropathy. Annals of the Rheumatic Diseases. 2005;64:788–789
  52. Michel M, Duvoux C, Hezode C, Cherqui D. Fulminant hepatitis after infliximab in a patient with hepatitis B virus treated for adult onset Still's disease. The Journal of Rheumatology. 2003;30:1624–1625
  53. Ueno Y, Tanaka S, Shimamoto M, et al. Infliximab therapy for Crohn's disease in a patient with chronic hepatitis B. Digestive Diseases and Sciences. 2005;50:163–166
  54. Esteve M, Saro C, Gonzales-Huix F, et al. Chronic hepatitis B reactivation following infliximab therapy in Crohn's disease patients: need for primary prophylaxis. Gut. 2004;53:1363–1365
  55. Calabrese LH, Zein N, Vassilopoulos D. Safety of antitumour necrosis factor (anti-TNF) therapy in patients with chronic viral infections: hepatitis C, hepatitis B, and HIV infection. Annals of the Rheumatic Diseases. 2004;63:18–24
  56. del Valle Garcia-Sanchez M, Gomez-Camacho F, Poyato-Gonzales A, et al. Infliximab therapy in a patient with Crohn's disease and chronic hepatitis B virus infection. Inflammatory Bowel Diseases. 2004;10:701–702
  57. Vassilopoulos D, Calabrese LH. Rheumatic aspects of human immunodeficiency virus infection and other immunodeficient states. In:  Hochberg MC,  Silman AJ,  Smolen JS,  Weinblatt ME,  Weisman MH editor. Rheumatology. London: Mosby; 2003;p. 1115–1129
  58. Duh EJ, Maury WJ, Folks TM, et al. Tumour necrosis factor alpha activates human immunodeficiency virus type 1 through induction of nuclear factor binding to the NF-kappa B sites in the long terminal repeat. Proceedings of the National Academy of Sciences of the United States of America. 1989;86:5974–5978
  59. Whalen C, Horsburgh CR, Hom D, et al. Accelerated course of human immunodeficiency virus infection after tuberculosis. American Journal of Respiratory and Critical Care Medicine. 1995;151:129–135
  60. Walker RE, Spooner KM, Kelly G, et al. Inhibition of immunoreactive tumor necrosis factor-alpha by a chimeric antibody in patients infected with human immunodeficiency virus type 1. The Journal of Infectious Diseases. 1996;174:63–68
  61. Sha BE, Valdez H, Gelman RS, et al. Effect on etanercept (Enbrel) on interleukin 6, tumor necrosis factor alpha, and markers of immune activation in HIV-infected subjects receiving interleukin 2. AIDS Research and Human Retroviruses. 2002;18:661–665
  62. Wallis RS, Kyambadde P, Johnson JL, et al. A study of the safety, immunology, virology, and microbiology of adjunctive etanercept in HIV-1 associated tuberculosis. AIDS. 2004;18:257–264
  63. Aboulafia DM, Bundow D, Wilske K, Ochs UI. Etanercept for the treatment of human immunodeficiency virus-associated psoriatic arthritis. Mayo Clinic proceedings. Mayo Clinic. 2000;75:1093–1098
  64. Gaylis N. Infliximab in the treatment of an HIV positive patient with Reiter's syndrome. The Journal of Rheumatology. 2003;30:407–411
  65. Bartke U, Venten I, Kreuter A, et al. Human immunodeficiency virus-associated psoriasis and psoriatic arthritis treated with infliximab. British Journal of Dermatology. 2004;150:784–786
  66. Allendoerfer R, Deepe GS. Blockade of endogenous TNF-alpha exacerbates primary and secondary pulmonary histoplasmosis by differential mechanisms. The Journal of Immunology. 1998;160:6072–6082
  67. Bauman SK, Huffnagle GB, Murphy JW. Effects of tumor necrosis factor alpha on dendritic cell accumulation in lymph nodes draining the immunization site and the impact on the anticryptococcal cell-mediated immune response. Infection and Immunity. 2003;71:68–74
  68. Beaman L. Effects of recombinant gamma interferon and tumor necrosis factor on in vitro interactions of human mononuclear phagocytes with Coccidiodes immitis. Infection and Immunity. 1991;59:4227–4229
  69. Mehrad B, Strieter RM, Standiford TJ. Role of TNF alpha in pulmonary host defense in murine invasive aspergillosis. The Journal of Immunology. 1999;162:1633–1640
  70. Kolls JK, Lei D, Vasquez C, et al. Exacerbation of murine Pneumocystis carinii infection by adenoviral-mediated gene transfer of a TNF inhibitor. American Journal of Respiratory Cell and Molecular Biology. 1997;16:112–118
  71. Wood KL, Hage CA, Knox KS, et al. Histoplasmosis after treatment with anti-tumor necrosis factor-alpha therapy. American Journal of Respiratory and Critical Care Medicine. 2003;167:1279–1282
  72. Nakelchik M, Mangino JE. Reactivation of histoplasmosis after treatment with infliximab. The American Journal of Medicine. 2002;112:78
  73. Zhang Z, Correa H, Begue RE. Tuberculosis and treatment with infliximab. The New England Journal of Medicine. 2002;346:623–626
  74. Keenan GF, Schaible TF, Boscia JA. Invasive pulmonary aspergillosis associated with infliximab therapy. The New England Journal of Medicine. 2001;344:1100
  75. Kaur N, Mahl TC. Pneumocystis carinii pneumonia with oral candidiasis after infliximab therapy for Crohn's disease. Digestive Diseases and Sciences. 2004;49:1458–1460
  76. Doty JD, Mazur JE, Judson MA. Treatment of sarcoidosis with infliximab. Chest. 2005;127:1064–1071
  77. Belda A, Hinojosa J, Serra B, et al. Systemic candidiasis and infliximab therapy. Gastroenterología y Hepatología. 2004;27:365–367
  78. Warris A, Bjorneklett A, Gaustad P. Invasive pulmonary aspergillosis associated with infliximab therapy. The New England Journal of Medicine. 2001;344:1099–1100
  79. De Rosa FG, Bonora S, Di Perri G. Tuberculosis and treatment with infliximab. The New England Journal of Medicine. 2002;346:623–626
  80. van der Klooster JM, Bosman RJ, Oudemans-van Straaten HM, et al. Disseminated tuberculosis, pulmonary aspergillosis and cutaneous herpes simplex infection in a patient with infliximab and methotrexate. Intensive Care Medicine. 2003;29:2327–2329
  81. Jacobsohn DA, Hallick J, Anders V, et al. Infliximab for steroid-refractory acute GVHD: a case series. American Journal of Hematology. 2003;74:119–124
  82. True DG, Penmetcha M, Peckham SJ. Disseminated cryptococcal infection in rheumatoid arthritis treated with methotrexate and infliximab. The Journal of Rheumatology. 2002;29:1561–1563
  83. Hage CA, Wood KL, Winer-Muram HT, et al. Pulmonary cryptococcosis after initiation of anti-tumor necrosis factor-alpha therapy. Chest. 2003;124:2395–2397
  84. Shrestha RK, Stoller JK, Honari G, et al. Pneumonia due to Cryptococcus neoformans in a patient receiving infliximab: possible zoonotic transmission from a pet cockatiel. Respiratory Care. 2004;49:606–608
  85. Starrett WG, Czachor J, Dallal M & Drehmer T. Cryptococcal pneumonia following treatment with infliximab for rheumatoid arthritis. Abstract #374. 40th Annual Meeting of the Infectious Disease Society of America, Chicago, IL, October 2002.
  86. Arend SM, Kuijper EJ, Allaart CF, et al. Cavitating pneumonia after treatment with infliximab and prednisone. European Journal of Clinical Microbiology & Infectious Diseases. 2004;23:638–641
  87. Bergstrom L, Yocum DE, Ampel NM, et al. Increased risk of coccidioidomycosis in patients treated with tumor necrosis factor alpha antagonists. Arthritis and Rheumatism. 2004;50:1959–1966
  88. FDA Arthritis Advisory Committee Meeting . Available at: www.fda.gov/ohrms/dockets/ac/01/briefing/3779b2.htmJune 2001;
  89. Minee RC, Stokkers P, Riemens SC, Hommes DW. Pneumocystis pneumonia during infliximab for active Crohn's colitis. Nederlands Tijdschrift Voor Geneeskunde. 2005;149:2290–2295
  90. Velayos FS, Sandborn WJ. Pneumocystis carinii pneumonia during maintenance anti-tumor necrosis factor-alpha therapy with infliximab for Crohn's disease. Inflammatory Bowel Diseases. 2004;10:657–660
  91. Tai TL, O'Rourke KP, McWeeney M, et al. Pneumocystis carinii pneumonia following a second infusion of infliximab. Rheumatology (Oxford). 2002;41:951–952
  92. Ljung T, Karlen P, Schmidt D, et al. Infliximab in inflammatory bowel disease: clinical outcome in a population based cohort from Stockholm County. Gut. 2004;53:849–853
  93. Gottlieb GS, Lesser CF, Holmes KK, Wald A. Disseminated sporotrichosis associated with treatment with immunosuppressants and tumor necrosis factor-alpha antagonists. Clinical Infectious Diseases. 2003;37:838–840
  94. Brown SL, Greene MH, Gershon SK, et al. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis and Rheumatism. 2002;46:3151–3158
  95. US Food and Drug Administration, Arthritis Drugs Advisory Committee . Safety Update on TNF-alpha Antagonists. Available at: www.fda.gov/ohrms/dockets/ac/03/briefing/3930b1.htm
  96. Wolfe F, Michaud K. Lymphoma in rheumatoid arthritis: the effect of methotrexate and anti-tumor necrosis factor therapy in 18,572 patients. Arthritis and Rheumatism. 2004;50:1740–1751
  97. Geborek P, Bladström A, Turesson C, et al. Tumour necrosis factor blockers do not increase overall tumour risk in patient with rheumatoid arthritis, but may be associated with an increased risk of lymphoma. Annals of the Rheumatic Diseases. 2005;64:699–703
  98. Askling J, Fored CM, Baecklund E, et al. Hematopoietic malignancies in rheumatoid arthritis: lymphoma risk and characteristics after exposure to tumour necrosis factor antagonists. Annals of the Rheumatic Diseases. 2005;64:1414–1420
  99. Colombel JF, Loftus EV, Tremaine WJ, et al. The safety profile of infliximab in patients with Crohn's disease: the Mayo Clinic experience in 500 patients. Gastroenterology. 2004;126:19–31
  100. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomized trial. Lancet. 2002;359:1541–1549
  101. Askling J, Fored CM, Brandt L, et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with tumour necrosis factor antagonists. Annals of the Rheumatic Diseases. 2005;64:1421–1426
  102. Levine B, Kalman J, Mayer L, et al. Elevated circulating levels of tumor necrosis factor in severe chronic heart failure. The New England Journal of Medicine. 1990;323:236–241
  103. Mann DL. Inflammatory mediators and the failing heart: past, present, and the foreseeable future. Circulation Research. 2002;91:988–998
  104. Deswal A, Bozkurt B, Seta Y, et al. Safety and efficacy of a soluble P75 tumor necrosis factor receptor (Enbrel, etanercept) in patients with advanced heart failure. Circulation. 1999;99:3224–3226
  105. Bozkurt B, Torre-Amione G, Warren MS, et al. Results of targeted anti-tumor necrosis factor therapy with etanercept (ENBREL) in patients with advanced heart failure. Circulation. 2001;103:1044–1047
  106. Mann D, McMurray J, Packer M, et al. Targeted anticytokine therapy in patients with chronic heart failure: results of the randomized etanercept worldwide evaluation (RENEWAL). Circulation. 2004;109:1594–1602
  107. Chung ES, Packer M, Lo KH, et al. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-α, in patients with moderate-to-severe heart failure: results of the anti-TNF Therapy Against Heart Failure (ATTACH) trial. Circulation. 2003;107:3133–3140
  108. Kwon HJ, Cote TR, Cuffe MS, et al. Case reports of heart failure after therapy with a tumor necrosis factor antagonist. Annals of Internal Medicine. 2003;138:807–811
  109. Wolfe F, Michaud MS. Heart failure in rheumatoid arthritis: rates, predictors, and the effect of anti-tumor necrosis factor therapy. The American Journal of Medicine. 2004;116:305–311
  110. Khanna D, McMahon M, Furst DE. Safety of tumour necrosis factor-α antagonists. Drug Safety. 2004;27:307–324
  111. Kuruvilla J, Leitch HA, Vickars LM, et al. Case report: aplastic anemia following administration of a tumor necrosis factor-α inhibitor. European Journal of Haematology. 2003;71:396–398
  112. Quartier P, Taupin P, Bourdeaut F, et al. Efficacy of etanercept for the treatment of juvenile idiopathic arthritis according to the onset type. Arthritis and Rheumatism. 2003;49:1093–1101
  113. Callegari P, Zelinger D, Hendricks D et al. Review of anti-TNF agents safety data obtained from the Food and Drug Administration Freedom of Information Database. Abstract presented at EULAR, Berlin, 2004.
  114. Keystone E. Tumor necrosis factor-alpha blockade in the treatment of rheumatoid arthritis. Rheumatic Diseases Clinics of North America. 2001;27:427–443
  115. Seiderer J, Goke B, Ochsenkuhn T. Safety aspects of infliximab in inflammatory bowel disease patients. A retrospective cohort study in 100 patients of a German university hospital. Digestion. 2004;70:3–9
  116. Menon Y, Cucurull E, Espinoza LR. Pancytopenia in a patient with scleroderma treated with infliximab. Rheumatology (Oxford). 2003;42:1273–1274
  117. Marchesoni A, Arreghini M, Panni B, et al. Life-threatening reversible bone marrow toxicity in a rheumatoid arthritis patient switched from leflunomide to infliximab. Rheumatology (Oxford). 2003;42:193–194
  118. Dufour C, Corcione A, Svahn J, et al. TNF-alpha and IFN-gamma are overexpressed in the bone marrow of Fanconi anemia patients and TNF-alpha suppresses erythropoiesis in vitro. Blood. 2003;102:2053–2059
  119. Rusten LS, Jacobsen SE. Tumor necrosis factor (TNF)-alpha directly inhibits human erythropoiesis in vitro: role of p55 and p75 TNF receptors. Blood. 1995;85:989–996
  120. Steensma DP, Mesa RA, Li CY, et al. Etanercept, a soluble tumor necrosis factor receptor, palliates constitutional symptoms in patients with myelofibrosis with myeloid metaplasia: results of a pilot study. Blood. 2002;99:2252–2254
  121. Furst DE, Breedveld FC, Kalden JR, et al. Updated consensus statement on biologic agents, specifically tumour necrosis factor α (TNFα) blocking agents and interleukin-1 receptor antagonist (IL-1ra), for the treatment of rheumatic diseases, 2005. Annals of the Rheumatic Diseases. 2005;64:iv2–iv14
  122. Mohan N, Edwards ET, Cupps TR, et al. Leukocytoclastic vasculitis associated with tumor necrosis factor-alpha blocking agents. The Journal of Rheumatology. 2004;31:1885–1887
  123. Stokes MB, Foster K, Markowitz GS, et al. Development of glomerulonephritis during anti-TNF-alpha therapy for rheumatoid arthritis. Nephrology, Dialysis, Transplantation. 2005;20:1400–1406
  124. Doulton TWR, Tucker B, Reardon J, Velasco N. Antineutrophil cytoplasmic antibody-associated necrotizing crescentic glomerulonephritis in a patient receiving treatment with etanercept for severe rheumatoid arthritis. Clinical Nephrology. 2004;62:234–238
  125. den Broeder AA, Assmann KJ, van Riel PL, Wetzels JF. Nephrotic syndrome as a complication of anti-TNFalpha in a patient with rheumatoid arthritis. The Netherlands Journal of Medicine. 2003;61:137–141
  126. Kemp E, Nielsen H, Peterson LJ, et al. Newer immunomodulating drugs in rheumatoid arthritis may precipitate glomerulonephritis. Clinical Nephrology. 2001;55:87–88
  127. Mor A, Bingham C, Barisoni L, et al. Proliferative lupus nephritis and leukocytoclastic vasculitis during treatment with etanercept. The Journal of Rheumatology. 2005;32:740–743
  128. Roux CH, Brocq O, Albert C Breuil V, Euller-Ziegler L. Cutaneous vasculitis and glomerulonephritis in a patient taking the anti-TNF alpha agent etanercept for rheumatoid arthritis. Joint Bone Spine. 2004;71:444–445
  129. ACR Hotline . FDA Advisory Committee Reviews Safety of TNF Inhibitors. Atlanta: American College of Rheumatology; 2001;
  130. Sharief MK, Hentges R. Association between tumor necrosis factor-alpha and disease and disease progression in patients with multiple sclerosis. The New England Journal of Medicine. 1991;325:467–472
  131. Maimome D, Gregory S, Arnason BGW, Reder AT. Cytokine levels in the cerebrospinal fluid and serum of patients with multiple sclerosis. The Journal of Neuroimmunology. 1991;32:67–74
  132. Misawa S, Kuwabara S, Mori M, et al. Serum levels of tumor necrosis factor-α in chronic inflammatory demyelinating polyneuropathy. Neurology. 2001;56:666–669
  133. Wagner R, Janjigian M, Myers RR. Anti-inflammatory interleukin-10 therapy in CCI neuropathy decreases thermal hyperalgesia, macrophage recruitment and endoneural TNF-alpha expression. Pain. 1998;74:35–42
  134. Chin RL, Sherman WH, Sander HW, et al. Etanercept (Enbrel) therapy for chronic inflammatory demyelinating polyneuropathy. Journal of the Neurological Sciences. 2003;210:19–21
  135. The Lenercept Multiple Sclerosis Study Group . TNF neutralization in MS: results of a randomized, placebo-controlled multicenter study; the Lenercept Multiple Sclerosis Study Group and the University of British Columbia MS/MRI analysis group. Neurology. 1999;53:457–465
  136. van Oosten BW, Barkhof F, Truyen L, et al. Increased MRI activity and immune activation in two multiple sclerosis patients treated with the monoclonal anti-tumor necrosis factor antibody CA2. Neurology. 1996;47:1531–1534
  137. Mohan N, Edwards ET, Cupps TR, et al. Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides. Arthritis and Rheumatism. 2001;44:2862–2869
  138. Fleischmann R, Baumgartner SW, Weismain M, et al. Long-term safety of etanercept in elderly subjects with rheumatic diseases. Annals of the Rheumatic Diseases. 2005;21:Sep [E pub ahead of print]
  139. Noguera-Pons R, Borras-Blasco J, Romero-Crespo I, et al. Optic neuritis with concurrent etanarcept and isoniazid therapy. The Annals of Pharmacotherapy. 2005;39:2131–2135
  140. Suskal SA, Nadiminti L, Granstein RD. Etanercept and demyelinating disease in a patient with psoriasis. Journal of the American Academy of Dermatology. 2006;54:160–164
  141. Richez C, Blanco P, Lagueny A, et al. Neuropathy resembling CIDP in patients receiving tumor necrosis factor-alpha blockers. Neurology. 2005;64:1468–1470
  142. Freeman HJ, Flak B. Demyelination-like syndrome in Crohn's disease after infliximab therapy. Canadian Journal of Gastroenterology. 2005;19:313–316
  143. Enayati PJ, Papadakis KA. Association of anti-tumor necrosis therapy with the development of multiple sclerosis. Journal of Clinical Gastroenterology. 2005;39:303–306
  144. Thomas CW, Weinshenker BG, Sandborn WJ. Demyelination during anti-tumor necrosis factory alpha therapy with infliximab for Crohn's disease. Inflammatory Bowel Diseases. 2004;10:28–31
  145. Rodriguez-Escalara C, Belzunegui J, Lopez-Dominguez L, et al. Multifocal motor neuropathy with conduction block in a patient with rheumatoid arthritis on infliximab therapy. Rheumatology (Oxford). 2005;44:132–133
  146. Richette P, Dieude P, Damiano J, et al. Sensory neuropathy revealing necrotizing vasculitis during infliximab therapy for rheumatoid arthritis. The Journal of Rheumatology. 2004;31:2079–2081
  147. Cisternas M, Gutierrez M, Jacobelli S. Successful rechallenge with anti-tumor necrosis factor alpha for psoriatic arthritis after development of demyelinating nervous system disease during initial treatment: comment on the article by Mohan et al. Arthritis and Rheumatism. 2002;46:3107–3108
  148. Berthelot CN, George SJ, Hsu S. Distal lower extremity paresthesia and foot drop developing during adalimumab therapy. Journal of the American Academy of Dermatology. 2005;53(supplement 1):S260–S262
  149. FDA Briefing Document . Safety Update on TNF-alpha Antagonists: Infliximab and Etanercept. FDA; 2001;
  150. Gupta G, Gelfand JM, Lewis JD. Increased risk for demyelinating diseases in patients with inflammatory bowel disease. Gastroenterology. 2005;129:819–826
  151. Zelster R, Valle L, Tanck C, et al. Clinical, histological, and immunophenotypic characteristics of injection site reactions associated with etanercept: a recombinant tumor necrosis factor alpha receptor: Fc fusion protein. Archives of Dermatology. 2001;137:893–899
  152. Etanercept (Enbrel) package insert, 2003.
  153. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. The New England Journal of Medicine. 2000;343:1586–1593
  154. Wells AF, Kupper H, Fischoff S, et al. Incidence of injection-site reactions association with adalimumab (D2E7) given subcutaneously for at least 6 months: a retrospective analysis of 4 phase 2/3 clinical trials. Arthritis and Rheumatism. 2002;46:S171
  155. Infliximab (Remicade) package insert, 2002.
  156. Cheifetz A, Smedley M, Martin S, et al. The incidence and management of infusion reactions to infliximab: a large center experience. The American Journal of Gastroenterology. 2003;98:1315–1324
  157. Kavanaugh A, Keenan GF, DeWoody K, et al. Long-term follow-up of patients treated with infliximab in all completed clinical trials category. Arthritis and Rheumatism. 2002;46:S535
  158. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. The New England Journal of Medicine. 2003;348:601–608
  159. Caramaschi P, Biasi D, Colombatti M, et al. Anti-TNFα therapy in rheumatoid arthritis and autoimmunity. Rheumatology International. 2004;296–308
  160. Sellam J, Allanore Y, Batteux F, et al. Autoantibody induction in patients with refractory spondyloarthropathy treated with infliximab and etanercept. Joint Bone Spine. 2005;72:48–52
  161. Eriksson C, Engstrand S, Sundqvist KG, Rantapää-Dahlqvist S. Autoantibody formation in patients with rheumatoid arthritis treated with anti-TNFα. Annals of the Rheumatic Diseases. 2005;64:403–407
  162. Klareskog L, Wajdula J, Yeh P, et al. Low autoantibody and anti-etanercept antibody formation and lack of impact on clinical outcomes after five years of treatment with etanercept in patients with rheumatoid arthritis. Arthritis and Rheumatism. 2005;52(supplement):S348;[abstract 881]
  163. Kapetanovic MC, Geborek P, Saxne T, et al. Development of antibodies against infliximab during infliximab treatment in rheumatoid arthritis: relation to infusion reactions and treatment response. Arthritis and Rheumatism. 2005;52(supplement):S543;[abstract 1440]
  164. De Rycke L, Baeten D, Kruithof E, et al. Infliximab, but not etanercept, induces IgM anti-double-stranded DNA autoantibodies as main antinuclear reactivity. Arthritis and Rheumatism. 2005;52:2192–2201
  165. Jonsdottir T, Forslid J, van Vollenhoven A, et al. Treatment with TNF alpha antagonists in patients with rheumatoid arthritis induces anti-cardiolipin antibodies. Annals of the Rheumatic Diseases. 2004;63:1068–1075
  166. Ferraccioli G, Mecchia F, DiPoi E, Fabris M. Anti-cardiolipin antibodies in rheumatoid arthritis patients treated with etanercept or conventional combination therapy: direct and indirect evidence for a possible association with infections. Annals of the Rheumatic Diseases. 2002;61:358–361
  167. Allanore Y, Sellam J, Batteux F, et al. Induction of autoantibody in refractory rheumatoid arthritis patients treated by infliximab. Clinical and Experimental Rheumatology. 2004;22:756–758
  168. Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Incidence of human anti-humanized antibodies (HAHAs) to adalimumab in relationship to clinical response in patients with rheumatoid arthritis. Arthritis and Rheumatism. 2005;52(supplement):S560;[abstract 1489]
  169. De Bandt M, Sibilia J, Le Loët X, et al. Systemic lupus erythematosus induced by anti-tumor necrosis factor alpha therapy: a French national survey. Arthritis Research & Therapy. 2005;7:R545–R551

PII: S1521-6942(06)00072-6

doi: 10.1016/j.berh.2006.06.002

Best Practice & Research Clinical Rheumatology
Volume 20, Issue 4 , Pages 757-790 , August 2006

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