The benefit/risk profile of TNF-blocking agents: Findings of a consensus panel

Seminars in Arthritis and Rheumatism

Volumn 34, Issue 6, 2005, Pages 819-836

  Hochberg, Marc C ^a   Lebwohl, Mark G ^b   Plevy, Scott E ^c   Hobbs, Kathryn F ^d   Yocum, David E ^e,f  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^d UNIVERSITY OF COLORADO   (United States)

^e UNIVERSITY OF ARIZONA   (United States)

^f Arizona Arthritis Center   (United States)

Author keywords

Adalimumab; Benefit risk; CD; Etanercept; Infliximab; Psoriasis; RA; TNF blockers

Indexed keywords

ADALIMUMAB; ANALGESIC AGENT; AZATHIOPRINE; CHLOROQUINE; CORTICOSTEROID; CYCLOSPORIN; ETANERCEPT; ETHAMBUTOL; ETRETIN; HYDROCORTISONE; HYDROXYCHLOROQUINE; INFLIXIMAB; ISONIAZID; LEFLUNOMIDE; LIVE VACCINE; MERCAPTOPURINE; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; ONERCEPT; PNEUMOCOCCUS VACCINE; PYRAZINAMIDE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RIFAMPICIN; TUMOR NECROSIS FACTOR ANTIBODY;

ANKYLOSING SPONDYLITIS; BACTERIAL INFECTION; BLEEDING; CANCER RISK; CELLULITIS; CHILL; CLINICAL TRIAL; COCCIDIOIDOMYCOSIS; CONGESTIVE HEART FAILURE; CONSENSUS; CROHN DISEASE; DEMYELINATING DISEASE; DIZZINESS; DOSE RESPONSE; DRUG EFFICACY; DRUG TOLERABILITY; DYSPNEA; EDEMA; ERYTHEMA; FEVER; HEADACHE; HEART PALPITATION; HISTOPLASMOSIS; HUMAN; HYPEREMIA; HYPERTENSION; HYPOTENSION; ILEITIS; IMMUNOGENICITY; INFECTION; INFECTION RISK; JUVENILE RHEUMATOID ARTHRITIS; LYMPHOMA; NAUSEA; NEPHROTOXICITY; OPPORTUNISTIC INFECTION; PAIN; PHOTOTHERAPY; PHYSICIAN; PNEUMONIA; PREGNANCY; PRIORITY JOURNAL; PRURITUS; PSORIASIS; PSORIATIC ARTHRITIS; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SKIN DISEASE; STRIDOR; SYSTEMIC LUPUS ERYTHEMATOSUS; THORAX PAIN; TREATMENT CONTRAINDICATION; TUBERCULOSIS;

EID: 19644364586     PISSN: 00490172     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.semarthrit.2004.11.006     Document Type: Article

References (116)

1. Immunex Corp. Enbrel [package insert]. Seattle, WA, 2002.
2. Centocor Inc. Remicade [package insert]. Malvern, PA, 2003.
3. Abbott Laboratories. Humira [package insert]. North Chicago, IL, 2003.
4. A. Kavanaugh, E.W. St Clair, W.J. McCune, T. Braakman, P. Lipsky Chimeric anti-tumor necrosis factor-alpha monoclonal antibody treatment of patients with rheumatoid arthritis receiving methotrexate therapy J Rheumatol 27 2000 841 850
5. C.A. Smith, T. Farrah, R.G. Goodwin The TNF receptor superfamily of cellular and viral proteins activation, costimulation, and death Cell 76 1994 959 962
6. L.W. Moreland, M.H. Schiff, S.W. Baumgartner, E.A. Tindall, R.M. Fleischmann, K.J. Bulpitt Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial Ann Intern Med 130 1999 478 486
7. R.N. Maini, F.C. Breedveld, J.R. Kalden, J.S. Smolen, D. Davis, J.D. Macfarlane Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis Arthritis Rheum 41 1998 1552 1563
8. L.B.A. Van de Putte, C. Atkins, M. Malaise, J. Sany, A.S. Russell, P.L.C. van Riel Efficacy and safety of adalimumab (D2E7), the first fully human anti-TNF monoclonal antibody in patients with rheumatoid arthritis who failed previous DMARD therapy 6-month results from a phase III study Ann Rheum Dis 61 2002 168
9. American College of Rheumatology Subcommittee on Rheumatoid Arthritis G Guidelines for the management of rheumatoid arthritis 2002 Update Arthritis Rheum 46 2002 328 346
10. E.C. Keystone, M.H. Schiff, J.M. Kremer, S. Kafka, M. Lovy, T. DeVries Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis results of a multicenter, randomized, double-blind, placebo-controlled trial Arthritis Rheum 50 2004 353 363
11. M.E. Weinblatt, J.M. Kremer, A.D. Bankhurst, K.J. Bulpitt, R.M. Fleischmann, R.I. Fox A trial of etanercept, a recombinant tumor necrosis factor receptor Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate N Engl J Med 340 1999 253 259
12. R. Maini, E.W. St Clair, F. Breedveld, D. Furst, J. Kalden, M. Weisman Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate a randomised phase III trial Lancet 354 1999 1932 1939
13. M.E. Weinblatt, E.C. Keystone, D.E. Furst, L.W. Moreland, M.H. Weisman, C.A. Birbara Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate the ARMADA trial [erratum appears in Arthritis Rheum 2003 Mar;48(3):855] Arthritis Rheum 48 2003 35 45
14. M.C. Hochberg, J.K. Tracy, M. Hawkins-Holt, R.H. Flores Comparison of the efficacy of the tumour necrosis factor alpha blocking agents adalimumab, etanercept, and infliximab when added to methotrexate in patients with active rheumatoid arthritis Ann Rheum Dis 62 Suppl. 2 2003 ii13 ii16
15. E. Keystone, A.F. Kavanaugh, J. Sharp, Y. Hua, L. Teoh, S. Fischkoff Adalimumab (D2E7), a fully human anti-TNF--a monoclonal antibody, inhibits the progression of structural joint damage in patients with active RA despite concomitant methotrexate therapy Arthritis Rheum 46 2002 abstract 468
16. D.E. Furst, M.H. Schiff, R.M. Fleischmann, V. Strand, C.A. Birbara, D. Compagnone Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis) J Rheumatol 30 2003 2563 2571
17. P.E. Lipsky, D.M. van der Heijde, E.W. St Clair, D.E. Furst, F.C. Breedveld, J.R. Kalden Infliximab and methotrexate in the treatment of rheumatoid arthritis N Engl J Med 343 2000 1594 1602
18. J.S. Smolen, P. Emery, J. Bathon, E. Keystone, R.N. Maini, J. Kalden Treatment of early rheumatoid arthritis with infliximab plus methotrexate or methotrexate alone preliminary results of the ASPIRE trial 2003 [abstract OP0001]. Paper presented at European League Against Arthritis Jun 9-12; Lisbon
19. L. Klareskog, D. van der Heijde, J.P. de Jager, A. Gough, J. Kalden, M. Malaise Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis double-blind randomised controlled trial Lancet 363 2004 675 681
20. J.F. Fries, P.W. Spitz, D.Y. Young The dimensions of health outcomes the health assessment questionnaire, disability and pain scales J Rheumatol 9 1982 789 793
21. R. Maini, D. van der Heijde, J. Smolen, J. Kalden, F. Breedveld, P. Emery 102-week clinical and radiologic results from the ATTRACT trial a 2 year randomized, controlled, phase 3 trial of infliximab (Remicade®) in patients with active rheumatoid arthritis despite methotrexate Ann Rheum Dis 60 2001 abstract FRI0068
22. K.E. Hansen, J.J. Cush, S. Patel, M.C. Genovese, M. Schiff The efficacy of switching from etanercept to infliximab in patients with rheumatoid arthritis Arthritis Rheum 46 2002 abstract 1439
23. R. van Vollenhoven, A. Harju, S. Brannemark, L. Klareskog Treatment with infliximab (Remicade) when etanercept (Enbrel) has failed or vice versa data from the STURE registry showing that switching tumour necrosis factor alpha blockers can make sense Ann Rheum Dis 62 2003 1195 1198
24. H.T. Ang, S. Helfgott Do the clinical responses and complications following etanercept or infliximab therapy predict similar outcomes with the other tumor necrosis factor-alpha antagonists in patients with rheumatoid arthritis? J Rheumatol 30 2003 2315 2318
25. P.J. Mease, B.S. Goffe, J. Metz, A. VanderStoep, B. Finck, D.J. Burge Etanercept in the treatment of psoriatic arthritis and psoriasis a randomised trial Lancet 356 2000 385 390
26. C. Antoni, A. Kavanaugh, B. Kirkham, G. Burmester, M. Weisman, E. Keystone The Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT) Arthritis Rheum 46 2002 abstract 985
27. J. Braun, T. Pham, J. Sieper, J. Davis, S. van der Linden, M. Dougados International ASAS consensus statement for the use of anti-tumour necrosis factor agents in patients with ankylosing spondylitis Ann Rheum Dis 62 2003 817 824
28. J.D. Gorman, K.E. Sack, J.C. Davis Jr Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha N Engl J Med 346 2002 1349 1356
29. J. Braun, J. Brandt, J. Listing, A. Zink, R. Alten, W. Golder Treatment of active ankylosing spondylitis with infliximab a randomised controlled multicentre trial Lancet 359 2002 1187 1193
30. S.R. Targan, S.B. Hanauer, S.J. van Deventer, L. Mayer, D.H. Present, T. Braakman A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease N Engl J Med 337 1997 1029 1035
31. W.R. Best, J.M. Becktel, J.W. Singleton, F. Kern Jr Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study Gastroenterology 70 1976 439 444
32. S.B. Hanauer, B.G. Feagan, G.R. Lichtenstein, L.F. Mayer, S. Schreiber, J.F. Colombel Maintenance infliximab for Crohn's disease the ACCENT I randomised trial Lancet 359 2002 1541 1549
33. B.G. Feagan, S. Yan, M. Bala, W. Bao, G.R. Lichtenstein The effects of infliximab maintenance therapy on health-related quality of life Am J Gastroenterol 98 2003 2232 2238
34. J.Y. Mary, R. Modigliani Groupe d'Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif (GETAID) Development and validation of an endoscopic index of the severity for Crohn's disease a prospective multicentre study Gut 30 1989 983 989
35. G. D'Haens, S. Van Deventer, R. Van Hogezand, D. Chalmers, C. Kothe, F. Baert Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease a European multicenter trial Gastroenterology 116 1999 1029 1034
36. W.J. Sandborn, S.B. Hanauer, S. Katz, M. Safdi, D.G. Wolf, R.D. Baerg Etanercept for active Crohn's disease a randomized, double-blind, placebo-controlled trial Gastroenterology 121 2001 1088 1094
37. P. Rutgeerts, L. Lemmens, G. Van Assche, M. Noman, I. Borghini-Fuhrer, R. Goedkoop Treatment of active Crohn's disease with onercept (recombinant human soluble p55 tumour necrosis factor receptor) results of a randomized, open-label, pilot study Aliment Pharmacol Ther 17 2003 185 192
38. D.H. Present, P. Rutgeerts, S. Targan, S.B. Hanauer, L. Mayer, R.A. van Hogezand Infliximab for the treatment of fistulas in patients with Crohn's disease N Engl J Med 340 1999 1398 1405
39. B. Sands, S. Van Deventer, C. Bernstein, M. Kamm, D. Rachmilewitz, W. Chey Long-term treatment of fistulizing Crohn's disease response to infliximab in the ACCENT II trial through 54 weeks Gastroenterology 122 2002 81 82
40. B.E. Sands, N.A. Thorne, P.A. Marsters, M.A. Blank Response to infliximab in fistulizing Crohn's disease is independent of baseline number of draining fistulas 2003 [abstract 723]. Paper presented at 68th Annual Meeting of the American College of Gastroenterology; Oct 10-15; Baltimore, MD, USA
41. J.A. Tuvlin, K.G. Schaefer, N.P. Sane, R.D. Cohen, S.B. Hanauer Infliximab is not a bridge to immunomodulators in Crohns disease 2003 [abstract 100582]. Paper presented at Digestive Diseases Week; May 17-22; Orlando, FL, USA
42. B.E. Sands, W.J. Tremaine, W.J. Sandborn, P.J. Rutgeerts, S.B. Hanauer, L. Mayer Infliximab in the treatment of severe, steroid-refractory ulcerative colitis a pilot study Inflamm Bowel Dis 7 2001 83 88
43. W.Y. Chey Infliximab for patients with refractory ulcerative colitis Inflamm Bowel Dis 7 Suppl. 1 2001 S30 S33
44. C.G. Su, B. Salzberg, J. Lewis, J. Deren, A. Kornbluth, D. Katzka Efficacy of anti-tumor necrosis factor therapy in patients with ulcerative colitis Am J Gastroenterol 96 2001 S310
45. P. Mamula, J.E. Markowitz, K.A. Brown, L.B. Hurd, D.A. Piccoli, R.N. Baldassano Infliximab as a novel therapy for pediatric ulcerative colitis J Pediatr Gastroenterol Nutr 34 2002 307 311
46. C.S. Probert, S.D. Hearing, S. Schreiber, T. Kuhbacher, S. Ghosh, I.D. Arnott Infliximab in moderately severe glucocorticoid resistant ulcerative colitis a randomised controlled trial Gut 52 2003 998 1002
47. A. Viscido, F.I. Habib, A. Kohn, C. Papi, A. Marcheggiano, M.T. Pimpo Infliximab in refractory pouchitis complicated by fistulae following ileo-anal pouch for ulcerative colitis Aliment Pharmacol Ther 17 2003 1263 1271
48. M. Regueiro, J. Valentine, S. Plevy, M.R. Fleisher, G.R. Lichtenstein Infliximab for treatment of pyoderma gangrenosum associated with inflammatory bowel disease Am J Gastroenterol 98 2003 1821 1826
49. M. Lebwohl Psoriasis Lancet 361 2003 1197 1204
50. U. Chaudhari, P. Romano, L.D. Mulcahy, L.T. Dooley, D.G. Baker, A.B. Gottlieb Efficacy and safety of infliximab monotherapy for plaque-type psoriasis a randomised trial Lancet 357 2001 1842 1847
51. R.E. Schopf, H. Aust, J. Knop Treatment of psoriasis with the chimeric monoclonal antibody against tumor necrosis factor alpha, infliximab J Am Acad Dermatol 46 2002 886 891
52. A.B. Gottlieb, S. Li, R. Evans, M.A. Menter Infliximab in the treatment of psoriasis results from the first 10 weeks of the phase II trial 2003 [abstract p596]. Paper presented at 61st Annual Meeting of the American Academy of Dermatology; Mar 21-26; San Francisco, CA, USA
53. C.L. Leonardi, J.L. Powers, R.T. Matheson, B.S. Goffe, R. Zitnik, A. Wang Etanercept as monotherapy in patients with psoriasis N Engl J Med 349 2003 2014 2022
54. C. Voigtlander, M. Luftl, G. Schuler, M. Hertl Infliximab (anti-tumor necrosis factor alpha antibody) a novel, highly effective treatment of recalcitrant subcorneal pustular dermatosis (Sneddon-Wilkinson disease) Arch Dermatol 137 2001 1571 1574
55. F. Martinez, P. Nos, S. Benlloch, J. Ponce Hidradenitis suppurativa and Crohn's disease response to treatment with infliximab Inflamm Bowel Dis 7 2001 323 326
56. C. Sacher, A. Rubbert, C. Konig, K. Scharffetter-Kochanek, T. Krieg, N. Hunzelmann Treatment of recalcitrant cicatricial pemphigoid with the tumor necrosis factor alpha antagonist etanercept J Am Acad Dermatol 46 2002 113 115
57. J.I. Henter, J. Karlen, U. Calming, C. Bernstrand, U. Andersson, B. Fadeel Successful treatment of Langerhans'-cell histiocytosis with etanercept N Engl J Med 345 2001 1577 1578
58. J.H. Stone, M.L. Uhlfelder, D.B. Hellmann, S. Crook, N.M. Bedocs, G.S. Hoffman Etanercept combined with conventional treatment in Wegener's granulomatosis a six-month open-label trial to evaluate safety Arthritis Rheum 44 2001 1149 1154
59. D. Khanna, M.R. Liebling, J.S. Louie Etanercept ameliorates sarcoidosis arthritis and skin disease J Rheumatol 30 2003 1864 1867
60. L. Mallbris, A. Ljungberg, M.A. Hedblad, P. Larsson, M. Stahle-Backdahl Progressive cutaneous sarcoidosis responding to anti-tumor necrosis factor-alpha therapy J Am Acad Dermatol 48 2003 290 293
61. J.H. Meyerle, A. Shorr The use of infliximab in cutaneous sarcoidosis J Drugs Dermatol 2 2003 413 414
62. H. Haley, W. Cantrell, K. Smith Infliximab therapy for sarcoidosis (lupus pernio) Br J Dermatol 150 2004 146 149
63. P.P. Sfikakis Behcet's disease a new target for anti-tumour necrosis factor treatment Ann Rheum Dis 61 Suppl. 2 2002 ii51 ii53
64. L.S. Simon Pharmacovigilance towards a better understanding of the benefit to risk ratio Ann Rheum Dis 61 Suppl. 2 2002 ii88 ii89
65. Food and Drug Administration Center for Biologics Evaluation and Research Safety and efficacy update on approved TNF-blocking agents 2003 Arthritis Advisory Committee March 4, 2003. Available at: http://www.fda.gov.ohrms/ dockets/ac/cder03.html#Arthritis. Accessed 26th July
66. T.R. Mikuls Co-morbidity in rheumatoid arthritis Best Pract Res Clin Rheumatol 17 2003 729 752
67. P.J. Mease, C. Ritchlin, R.W. Martin, A.B. Gottlieb, S.W. Baumgartner, D.J. Burge Response to pneumococcal vaccination in psoriatic arthritis patients treated with etanercept (Enbrel®) Ann Rheum Dis 61 2002 abstract SAT0144
68. J. Keane, S. Gershon, R.P. Wise, E. Mirabile-Levens, J. Kasznica, W.D. Schwieterman Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent N Engl J Med 345 2001 1098 1104
69. M.A. Gardam, E.C. Keystone, R. Menzies, S. Manners, E. Skamene, R. Long Anti-tumour necrosis factor agents and tuberculosis risk mechanisms of action and clinical management Lancet Infect Dis 3 2003 148 155
70. American College of Rheumatology Hotline FDA Meeting March 2003: update on the safety of new drugs for rheumatoid arthritis. Part II: CHF, infection and other safety issues 2003 Available at: http://www.rheumatology.org/ publications/hotline/0803chf.asp. Accessed 10 July 2003
71. J.J. Gomez-Reino, L. Carmona, V.R. Valverde, E.M. Mola, M.D. Montero Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk a multicenter active-surveillance report Arthritis Rheum 48 2003 2122 2127
72. C.D. Hamilton Tuberculosis in the cytokine era what rheumatologists need to know Arthritis Rheum 48 2003 2085 2091
73. L. Carmona, C. Hernandez-Garcia, C. Vadillo, E. Pato, A. Balsa, I. Gonzalez-Alvaro Increased risk of tuberculosis in patients with rheumatoid arthritis J Rheumatol 30 2003 1436 1439
74. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Treatment of tuberculosis Am J Respir Crit Care Med 167 2003 603 662
75. Centers for Disease Control and Prevention. Dear Colleague Letter. Available at: http://www.cdc.gov/nchstp/tb/dearcolleague_8_9_03.htm. Accessed 28 October 2003, 2003.
76. J.H. Lee, N.R. Slifman, S.K. Gershon, E.T. Edwards, W.D. Schwieterman, J.N. Siegel Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor alpha antagonists infliximab and etanercept Arthritis Rheum 46 2002 2565 2570
77. A.K. Mohan, T.R. Cote, J.N. Siegel, M.M. Braun Infectious complications of biologic treatments of rheumatoid arthritis Curr Opin Rheumatol 15 2003 179 184
78. D.L. Mann, J.J. McMurray, M. Packer, K. Swedberg, J.S. Borer, W.S. Colucci Targeted anticytokine therapy in patients with chronic heart failure results of the Randomized Etanercept Worldwide Evaluation (RENEWAL) Circulation 109 2004 1594 1602
79. E.S. Chung, M. Packer, K.H. Lo, A.A. Fasanmade, J.T. Willerson Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-to-severe heart failure results of the anti-TNF Therapy Against Congestive Heart Failure (ATTACH) trial Circulation 107 2003 3133 3140
80. H.J. Kwon, T.R. Cote, M.S. Cuffe, J.M. Kramer, M.M. Braun Case reports of heart failure after therapy with a tumor necrosis factor antagonist Ann Intern Med 138 2003 807 811
81. F. Wolfe, K. Michaud Heart failure in rheumatoid arthritis rates, predictors, and the effect of anti-tumor necrosis factor therapy Am J Med 116 2004 305 311
82. American College of Rheumatology Hotline. FDA Meeting March 2003: update on the safety of new drugs for rheumatoid arthritis. Part I: The risk of lymphoma with rheumatoid arthritis (RA) and TNF inhibitors. Available at: http://www.rheumatology.org/publications/hotline/0303tnfl.asp. Accessed 28th October, 2003.
83. G. Gridley, J.K. McLaughlin, A. Ekbom, L. Klareskog, H.O. Adami, D.G. Hacker Incidence of cancer among patients with rheumatoid arthritis J Natl Cancer Inst 85 1993 307 311
84. L. Mellemkjaer, M.S. Linet, G. Gridley, M. Frisch, H. Moller, J.H. Olsen Rheumatoid arthritis and cancer risk Eur J Cancer 32A 1996 1753 1757
85. K. Ekstrom, H. Hjalgrim, L. Brandt, E. Baecklund, L. Klareskog, A. Ekbom Risk of malignant lymphomas in patients with rheumatoid arthritis and in their first-degree relatives Arthritis Rheum 48 2003 963 970
86. K.O. Arseneau, G.J. Stukenborg, A.F. Connors Jr, F. Cominelli The incidence of lymphoid and myeloid malignancies among hospitalized Crohn's disease patients Inflamm Bowel Dis 7 2001 106 112
87. D. Margolis, W. Bilker, S. Hennessy, C. Vittorio, J. Santanna, B.L. Strom The risk of malignancy associated with psoriasis Arch Dermatol 137 2001 778 783
88. E. Baecklund, A. Ekbom, P. Sparen, N. Feltelius, L. Klareskog Disease activity and risk of lymphoma in patients with rheumatoid arthritis nested case-control study BMJ 317 1998 180 181
89. E.V. Loftus Jr, W.J. Sandborn Lymphoma risk in inflammatory bowel disease influences of referral bias and therapy Gastroenterology 121 2001 1239 1242
90. G.A. Dayharsh, E.V. Loftus Jr., W.J. Sandborn, W.J. Tremaine, A.R. Zinsmeister, T.E. Witzig Epstein-Barr virus-positive lymphoma in patients with inflammatory bowel disease treated with azathioprine or 6-mercaptopurine Gastroenterology 122 2002 72 77
91. M.C. Wasko Comorbid conditions in patients with rheumatic diseases an update Curr Opin Rheumatol 16 2004 109 113
92. F. Wolfe, K. Michaud Lymphoma in rheumatoid arthritis the effect of methotrexate and anti-tumor necrosis factor therapy in 18,572 patients Arthritis Rheum 50 2004 1740 1751
93. N. Mohan, E.T. Edwards, T.R. Cupps, P.J. Oliverio, G. Sandberg, H. Crayton Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides Arthritis Rheum 44 2001 2862 2869
94. The Lenercept Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group TNF neutralization in MS results of a randomized, placebo-controlled multicenter study Neurology 53 1999 457 465
95. C.L. Wagner, E.W. St Clair, C. Han, J. Ford, A. Schantz, R.N. Maini The effects of antibodies to infliximab on ACR response in patients with rheumatoid arthritis in the ATTRACT study Arthritis Rheum 46 2002 abstract 260
96. F. Baert, M. Noman, S. Vermeire, G. Van Assche, D.H. G, A. Carbonez Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease N Engl J Med 348 2003 601 608
97. R.J. Farrell, M. Alsahli, Y.T. Jeen, K.R. Falchuk, M.A. Peppercorn, P. Michetti Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease a randomized controlled trial Gastroenterology 124 2003 917 924
98. R.A. Watts Musculoskeletal and systemic reactions to biological therapeutic agents Curr Opin Rheumatol 12 2000 49 52
99. P.J. Charles, R.J. Smeenk, J. De Jong, M. Feldmann, R.N. Maini Assessment of antibodies to double-stranded DNA induced in rheumatoid arthritis patients following treatment with infliximab, a monoclonal antibody to tumor necrosis factor alpha findings in open-label and randomized placebo-controlled trials Arthritis Rheum 43 2000 2383 2390
100. M. Debandt, O. Vittecoq, V. Descamps, X. Le Loet, O. Meyer Anti-TNF-alpha-induced systemic lupus syndrome Clin Rheumatol 22 2003 56 61
101. E.G. Favalli, L. Sinigaglia, M. Varenna, C. Arnoldi Drug-induced lupus following treatment with infliximab in rheumatoid arthritis Lupus 11 2002 753 755
102. P. Sarzi-Puttini, S. Ardizzone, G. Manzionna, F. Atzeni, E. Colombo, M. Antivalle Infliximab-induced lupus in Crohn's disease a case report Dig Liver Dis 35 2003 814 817
103. L. Lepore, F. Marchetti, S. Facchini, V. Leone, A. Ventura Drug-induced systemic lupus erythematosus associated with etanercept therapy in a child with juvenile idiopathic arthritis Clin Exp Rheumatol 21 2003 276 277
104. N. Shakoor, M. Michalska, C.A. Harris, J.A. Block Drug-induced systemic lupus erythematosus associated with etanercept therapy Lancet 359 2002 579 580
105. V.J. Swale, C.M. Perrett, C.P. Denton, C.M. Black, M.H. Rustin Etanercept-induced systemic lupus erythematosus Clin Exp Dermatol 28 2003 604 607
106. A.P. Cairns, M.K. Duncan, A.E. Hinder, A.J. Taggart New onset systemic lupus erythematosus in a patient receiving etanercept for rheumatoid arthritis Ann Rheum Dis 61 2002 1031 1032
107. Y. Ali, S. Shah Infliximab-induced systemic lupus erythematosus Ann Intern Med 137 2002 625 626
108. A. Cheifetz, M. Smedley, S. Martin, M. Reiter, G. Leone, L. Mayer The incidence and management of infusion reactions to infliximab a large center experience Am J Gastroenterol 98 2003 1315 1324
109. Amgen. Kineret [package insert]. Thousand Oaks, CA, 2003.
110. M.C. Genovese, S.B. Cohen, L.W. Moreland, D. Lium, T. Tiu A randomized double-blind controlled study evaluating the safety and efficacy of etanercept vs etanercept plus anakinra in patients with rheumatoid arthritis Ann Rheum Dis 62 2003 66
111. M.H. Schiff, K. Bulpitt, A.A. Weaver, M.C. Genovese, S. Cohen Safety of combination therapy with anakinra and etanercept in patients with rheumatoid arthritis Arthritis Rheum 44 2001 79
112. H.H. Roenigk Jr, R. Auerbach, H. Maibach, G. Weinstein, M. Lebwohl Methotrexate in psoriasis consensus conference J Am Acad Dermatol 38 1998 478 485
113. M. Lebwohl, C. Ellis, A. Gottlieb, J. Koo, G. Krueger, K. Linden Cyclosporine consensus conference with emphasis on the treatment of psoriasis J Am Acad Dermatol 39 1998 464 475
114. C.E. Antoni, D. Furst, B. Manger, G.R. Lichtenstein, G.F. Keenan, D.E. Healy Outcome of pregnancy in women receiving Remicade (infliximab) for the treatment of Crohn's disease or rheumatoid arthritis Arthritis Rheum 44 2001 S152
115. R. Fleischmann, I. Iqbal, P. Nandeshwar, A. Quiceno Safety and efficacy of disease-modifying anti-rheumatic agents focus on the benefits and risks of etanercept Drug Saf 25 2002 173 197
116. J.A. Katz, G. Pore Inflammatory bowel disease and pregnancy Inflamm Bowel Dis 7 2001 146 157