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Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis

Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis Abstract Application of biological agents targeting tumor necrosis factor-α (TNF-α) caused a paradigm shift in the treatment of rheumatoid arthritis (RA). The introduction of infliximab in 2003 and etanercept in 2005 in Japan had a significant impact on both Japanese rheumatologists and RA patients, although serious adverse effects such as bacterial pneumonia, tuberculosis and Pneumocystis jiroveci pneumonia are significant concerns. Based on the data from post-marketing surveillance in Japan and accumulating evidence worldwide, the Internal Medicine Rheumatology Study Group of the Ministry of Health, Labor and Welfare (MHLW), Japan, has updated the guidelines for the use of anti-TNF-α agents for RA, which were subsequently approved by the Board of Japan College of Rheumatology (JCR). In the present revised guidelines, we combined the guidelines for use of each of infliximab and etanercept together with some modifications and precautions, paying special attention to serious adverse reactions. Although it is still controversial whether the use of TNF-α blocking agents per se increases the risk of infection or not, bacterial pneumonia, regardless of the pathogens, is the most frequent complications in RA. The risk factors associated with pneumonia identified in the post-marketing surveillance of infliximab in Japan are presented in this guideline. The diagnostic algorithm is also designed for early diagnosis and treatment of pulmonary lesions seen during the treatment of biological agents. Preventive measures and precautions against tuberculosis, another frequent and significant complication in Japan, are also described. Furthermore, risk factors for developing Pneumocystis pneumonia, which uniquely occurs at 30- to 50-fold frequency under TNF-α blockade therapy in Japan, are described here and its preventive measures are discussed. It is stressed that secondary-care rheumatologists should be better familiarized with the proper use of TNF-α blocking agents and be alert to any adverse events for a better management of RA patients. Adverse events, Etanercept, Infliximab, Rheumatoid arthritis, Treatment guidelines, Tumor necrosis factor-α antagonists References Miyasaka N , Takeuchi T, Eguchi K . Japanese guidelines for the use of infliximab for rheumatoid arthritis. Mod Ftheumatol 2005 ; 15 : 4 – 8 . Google Scholar OpenURL Placeholder Text WorldCat Miyasaka N , Takeuchi T, Eguchi K . Guidelines for the proper use of etanercept in Japan. Mod Ftheumatol 2006 ; 16 : 63 – 7 . Google Scholar OpenURL Placeholder Text WorldCat Information for proper use of infliximab ( in Japanese) by Tanabe Seiyaku. hap : //medical.tanabe.co.jp/mstaff/remicade/ index_remicade.shtml Information for proper use of etanercept . Vol. 4 (in Japanese) by Wyeth and Takeda Yakuhin, June 2006 . American College of Ftheumatology subcommittee on Rheuma-toid Arthritis Guidelines . Guidelines for the management of rheu-matoid arthritis . Arthritis Rheum 2002 ; 46 : 328 – 46 . Crossref Search ADS PubMed WorldCat Furst DE , Breedveld FC, Kalden JR, Smolen JS, Burmeater GR, Bijlsma JWJ, et al. Updated consensus statement on biological agents, specifically tumor necrosis factor a (TNFec) blocking agents and interleukin-1 receptor antagonist (IL-lra), for the treatment of rheumatic diseases, 2005 . Ann Rheum Dis 2005 ;64:iv2-iv 14 . Ledingham J , Deighton C. Update on the British Society for Ftheu-matology guidelines for prescribing TNFec blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001) . Ftheumatology 2005 ; 44 : 157 – 63 . Google Scholar Crossref Search ADS WorldCat Japan College of Ftheumatology, Official Guidelines for the use of anti-TNF agents for rheumatoid arthritis ( in Japanese). https : // www. r yuma chi -jp. com/Ryumachi/S e cur e/k aiin/me di c al/b rm_ guideline.html Arnett FC , Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised cri-teria for the classification of rheumatoid arthritis . Arthritis Rheum 1988 ; 31 : 315 – 24 . Google Scholar Crossref Search ADS PubMed WorldCat Study Group of the Ministry of Health, Labour and Welfare . Diag-nostic and therapeutic manual of rheumatoid arthritis. Diagnostic manual and evidence-based treatment guidelines (in Japanese). Japan Rheumatism Foundation; 2004 . McCurry J . Japan deaths spark concerns over arthritis drug . Lancet 31. 2004 ; 363 : 461 . Google Scholar Crossref Search ADS WorldCat Sakai F , Noma S, Kurihara Y, Yamada H,Azuma A, Kudoh S, et al. Leflunomide-related lung injury in patients with rheumatoid 32. arthritis : imaging features. Mod Ftheumatol 2005 ; 15: 173 – 9 . Ogawa J , Harigai M, Nagasaka K, Nakamura T, Miyasaka N. Predic-tion of and prophylaxis against Pneumocystis pneumonia in patients with connective tissue diseases undergoing medium- or high-dose 33. corticosteroid therapy. Mod Ftheumatol 2005 ; 15: 91 – 6 . Google Scholar OpenURL Placeholder Text WorldCat Obayashi T , Yoshida M, Mori T, Goto H, Yasuoka A, Iwasaki H, et al. Plasma (13)-3-glucan measurement in diagnosis of invasive 34 . deep mycosis and fungi febrile episodes. Lancet 1995 ; 345 : 17 – 20 . Google Scholar OpenURL Placeholder Text WorldCat Yasuoka A , Tachikawa N, Shimada K, Kimura S, Oka S. (1 3) P-D-glucan as a quantitative serological marker for Pneumocystis carinii 35. pneumonia. Clin Diagn Lab Immnunol 1996 ; 3: 197 – 9 . Google Scholar Crossref Search ADS WorldCat Saito K , Nakayamada S, Nakano K, Tokunaga M, Tsujimura S, Nakatsuka K, et al. Detection of Pneumocystis carinii by DNA amplification in patients with connective tissue diseases: re-evaluation of clinical features of P carinii pneumonia in rheumatic diseases . Ftheumatology 2004 ; 43 : 479-85 . 36 . Google Scholar OpenURL Placeholder Text WorldCat Calabrese LH , Zein NN, Vassilopoulos D. Hepatitis B virus (HBV) reactivation with immunosuppressive therapy in rheumatic dis-eases: assessment and preventive strategies. Ann Rheum Dis 2006 ; 65 : 983 – 9 . Wallis RS , Broder MS, Wong JY, Hanson ME, Beenhouwer DO. 37. Granulomatous infectious diseases associated with tumor necrosis factor antagonists. Clin Infect Dis 2004 ; 38: 1261 – 5 . Crum NF , Lederman ER, Wallace MR . Infections associated with tumor necrosis factor-a antagonists. Medicine 2005 ; 84 : 291-302 . 38 . Google Scholar OpenURL Placeholder Text WorldCat Mufti AH , Toye BW, Mckendry RRJ, Angel JB. Mycobacterium abscessus infection after use of tumor necrosis factor a inhibitor therapy: case report and review of infectious complications associ- 39 . ated with tumor necrosis factor a inhibitor use. Diagn Microbiol Infect Dis 2005 ; 53 : 233 – 8 . Google Scholar OpenURL Placeholder Text WorldCat Khanna D , McMahon M, Furst DE. Safety of tumour necrosis 40. factor-a antagonists. Drug Safety 2004 ; 27: 307 – 24 . Benson CA , Kaplan JE, Masur H, Pau A, Holmes KK. Treating opportunistic infections among HIV-infected adults and adoles-cents. Recommendations from CDC, the National Institutes of 41. Health, and the HIV Medicine Associated Diseases Society of America. MMWR 2004 ;53(RR15): 1 – 112 . Chung ES , Packer M, Lo KH, Fasanmade AA, Willerson JT. 42. Randomized, double-blind, placebo-controlled, pilot trial of inflix-imab, a chimeric monoclonal antibody to tumor necrosis factor-a, in patients with moderate-to-severe heart failure. Results of the anti-TNF therapy against congestive heart failure (ATTACH) trial. Circulation 2003 ; 107: 3133–40.43 . Kwon HJ , Cote TR, Cuffe MS, Kramer JM, Braun MM. Case reports of heart failure after therapy with a tumor necrosis factor 44. antagonist. Ann Intern Med 2003 ; 138: 807 – 12 . 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 45. study. Neurology 1999 : 53: 457 – 65 . Mohan N , Edwards ET, Cupps TR, Oliverio PJ, Sandberg G, Crayton H, et al. Demyelination occurring during anti-tumor necrosis factor a therapy for inflammatory arthritides . Arthritis 46. Rheum 2001 ; 44 : 2862 – 9 . Google Scholar Crossref Search ADS WorldCat Jarand J , Zochodne DW, Martin LO,Voll C . Neurological complica-tions of infliximab. J Ftheumatol 2006 ; 33 : 1018 – 20 . Google Scholar OpenURL Placeholder Text WorldCat Carswell EA , Old LJ, Kassel RL, Green S, Fiore N, Williamson B. 47. An endotoxin-induced serum factor that causes necrosis of tumors. Proc Nat Acad Sci USA 1975 ; 72: 3666 – 70 . Bendtzen K , Geborek P, Svenson M, Larsson L, Kapetanovic MC, 48 . Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor a inhibitor infliximab. Arthritis Rheum 2006 ; 54 : 3782-9 . 49 . Google Scholar OpenURL Placeholder Text WorldCat Klareskog L , Van der Heijde D, De Jager JP, Gough A, Kalden J, Malaise M, et al. Therapeutic effect of the combination of etaner-cept and methotrexate compared with each treatment alone in 50. patients with rheumatoid arthritis : double-blind randomised con-trolled trial. Lancet 2004 ; 363: 675 – 81 . Doran MF , Crowson CS, Pond GR, O'Fallon WM, Gabrial SE . Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002 ; 46 : 2294 – 300 . Google Scholar Crossref Search ADS WorldCat Wolfe F , Caplan L, Michaud K . Treatment of rheumatoid arthritis and the risk of hospitalization for pneumonia. Association with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy. Arthritis Rheum 2006 ; 54 : 628 – 34 . Google Scholar OpenURL Placeholder Text WorldCat Kroesen S , Widmer AF, Tyndall A, Hasler P. Serious bacterial infections in patients with rheumatoid arthritis under anti-TNF-� therapy . Rheumatology 2003 ; 42 : 617 – 21 . Google Scholar Crossref Search ADS PubMed WorldCat Listing J , Strangfeld A, Kary S, Rau R, Von Hinueber U, Stoyanova-Scholz M, et al . Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005 ; 52 : 3403 – 12 . Google Scholar OpenURL Placeholder Text WorldCat Dixon WG , Watson K, Lunt M, Hyrich KL, British Society for Rheumatology Biologics Register Control Centre Consorium, Silman AJ, et al . Rates of serious infection, including site-specifi c and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy. Arthritis Rheum 2006 ; 54 : 2368 – 76 . Google Scholar OpenURL Placeholder Text WorldCat Westhovens R , Yocum D, Han J, Berman A, Strusberg I, Geusens P, et al. The safety of infl iximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities . A large, randomized, placebo-controlled trial. Arthritis Rheum 2006 ; 54 : 1075 – 86 . Google Scholar OpenURL Placeholder Text WorldCat Carmona L , Gomez-Reino JJ, Rodriguez-Valverde V, Montero D, Pascual-Gomez E, Mola EE, et al. Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists . Arthritis Rheum 2005 ; 52 : 1766 – 72 . Google Scholar Crossref Search ADS PubMed WorldCat Label approved on 06/12/2007 of REMICADE, FDA homepage. Available from : URL: http://www.fda.gov/cder/foi/label/2007/ 103772s5189lbl.pdf Label approved on 02/01/2007 of ENBREL, FDA homepage. Available from : URL: http://www.fda.gov/cder/foi/label/2007/ 103795s5322lbl.pdf Wollner A , Mohle-Boetani J, Lambert E, Perruquet JL, Raffi n TA, McGuire JL . Pneumocystis carinii pneumonia complicating low dose methotrexate treatment for rheumatoid arthritis. Thorax 1991 ; 46 : 205 – 7 . Google Scholar OpenURL Placeholder Text WorldCat Tai TL , O'Rourke KP, McWeeney M, Burke CM, Sheehan K, Barry M. Pneumocystis carinii pneumonia following a second infusion of infl iximab . Rheumatology 2002 ; 41 : 951 – 2 . Google Scholar Crossref Search ADS PubMed WorldCat Lequerre T , Vittecoq O, Klemmer N, Goeb V, Pouplin S, Menard J-F, et al . Management of infusion reactions to infl iximab in patients with rheumatoid arthritis or spondyloarthritis: experience from an immunotherapy unit of rheumatology. J Rheumatol 2006 ; 33 : 1307 – 14 . Google Scholar OpenURL Placeholder Text WorldCat MedWatch , FD A home page. Available from: URL: http://www.fda. gov/medwatch/SAFETY/1998/infl ix.htm. Kugathasan S , Levy MB, Saeian K, Vasilopoulos S, Kim JP, Prajapati D, et al. Infl iximab retreatment in adults and children with Crohn's disease: risk factors for the development of delayed severe systemic reaction . Am J Gastroenterol 2002 ; 97 : 1408 – 14 . Google Scholar Crossref Search ADS PubMed WorldCat Sugiura F , Kojima T, Oba M, Tsuchiya H, Ishiguro N . Anaphylactic reaction to infl iximab in two rheumatoid arthritis patients who had previously received infl iximab and resumed. Mod Rheumatol 2005 ; 15 : 201 – 3 . Google Scholar OpenURL Placeholder Text WorldCat Giles JT , Bartlett SJ, Gelber AC, Nanda S, Fontaine K, Ruffi ng V, et al . Tumor necrosis factor inhibitor therapy and risk of serious postoperative orthopedic infection in rheumatoid arthritis. Arthritis Care Res 2006 ; 55 : 333 – 7 . Google Scholar OpenURL Placeholder Text WorldCat Centers for Disease Control and Prevention . Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000 ;49(No. RR-6): 26 – 39 . British Thoracic Society Standards of Care Committee . BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF- � treatment . Thorax 2005 ; 60 : 800 – 5 . 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Arthritis Rheum 2006 ; 54 : 2701 – 2 . Google Scholar Crossref Search ADS PubMed WorldCat Salmon JE , Alpert D. Are we coming to terms with tumor necrosis factor inhibition in pregnancy? Arthritis Rheum 2006 ; 54 : 2353 – 5 . Google Scholar Crossref Search ADS PubMed WorldCat Bongartz T , Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies . JAMA 2006 ; 295 : 2275 – 85 . Google Scholar Crossref Search ADS PubMed WorldCat Askling J , Fored CM, Baecklund E, Brandt L, Backlin C, Ekbom A, et al. Haematopoietic malignancies in rheumatoid arthritis: lymphoma risk and characteristics after exposure to tumour necrosis factor antagonists . Ann Rheum Dis 2005 ; 64 : 1414 – 20 . Google Scholar Crossref Search ADS PubMed WorldCat Wolfe F , Michaud K. Lymphoma in rheumatoid arthritis. The effect of methotrexate and anti-tumor necrosis factor therapy in 18,572 patients. 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Google Scholar Crossref Search ADS PubMed WorldCat Mariette X , Cazals-Hatem D, Warszawki J, Liote F, Balandraud N, Sibilia J, et al. Lymphomas in rheumatoid arthritis patients treated with methotrexate: a 3-year prospective study in France . Blood 2002 ; 99 : 3909 – 15 . Google Scholar Crossref Search ADS PubMed WorldCat This content is only available as a PDF. © 2007 Japan College of Rheumatology This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) © 2007 Japan College of Rheumatology http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Modern Rheumatology Oxford University Press

Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis

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Oxford University Press
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Copyright © 2022 Japan College of Rheumatology
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1439-7595
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1439-7609
DOI
10.3109/s10165-007-0626-3
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Abstract

Abstract Application of biological agents targeting tumor necrosis factor-α (TNF-α) caused a paradigm shift in the treatment of rheumatoid arthritis (RA). The introduction of infliximab in 2003 and etanercept in 2005 in Japan had a significant impact on both Japanese rheumatologists and RA patients, although serious adverse effects such as bacterial pneumonia, tuberculosis and Pneumocystis jiroveci pneumonia are significant concerns. Based on the data from post-marketing surveillance in Japan and accumulating evidence worldwide, the Internal Medicine Rheumatology Study Group of the Ministry of Health, Labor and Welfare (MHLW), Japan, has updated the guidelines for the use of anti-TNF-α agents for RA, which were subsequently approved by the Board of Japan College of Rheumatology (JCR). In the present revised guidelines, we combined the guidelines for use of each of infliximab and etanercept together with some modifications and precautions, paying special attention to serious adverse reactions. Although it is still controversial whether the use of TNF-α blocking agents per se increases the risk of infection or not, bacterial pneumonia, regardless of the pathogens, is the most frequent complications in RA. The risk factors associated with pneumonia identified in the post-marketing surveillance of infliximab in Japan are presented in this guideline. The diagnostic algorithm is also designed for early diagnosis and treatment of pulmonary lesions seen during the treatment of biological agents. Preventive measures and precautions against tuberculosis, another frequent and significant complication in Japan, are also described. Furthermore, risk factors for developing Pneumocystis pneumonia, which uniquely occurs at 30- to 50-fold frequency under TNF-α blockade therapy in Japan, are described here and its preventive measures are discussed. It is stressed that secondary-care rheumatologists should be better familiarized with the proper use of TNF-α blocking agents and be alert to any adverse events for a better management of RA patients. Adverse events, Etanercept, Infliximab, Rheumatoid arthritis, Treatment guidelines, Tumor necrosis factor-α antagonists References Miyasaka N , Takeuchi T, Eguchi K . Japanese guidelines for the use of infliximab for rheumatoid arthritis. Mod Ftheumatol 2005 ; 15 : 4 – 8 . Google Scholar OpenURL Placeholder Text WorldCat Miyasaka N , Takeuchi T, Eguchi K . Guidelines for the proper use of etanercept in Japan. Mod Ftheumatol 2006 ; 16 : 63 – 7 . Google Scholar OpenURL Placeholder Text WorldCat Information for proper use of infliximab ( in Japanese) by Tanabe Seiyaku. hap : //medical.tanabe.co.jp/mstaff/remicade/ index_remicade.shtml Information for proper use of etanercept . Vol. 4 (in Japanese) by Wyeth and Takeda Yakuhin, June 2006 . American College of Ftheumatology subcommittee on Rheuma-toid Arthritis Guidelines . Guidelines for the management of rheu-matoid arthritis . Arthritis Rheum 2002 ; 46 : 328 – 46 . Crossref Search ADS PubMed WorldCat Furst DE , Breedveld FC, Kalden JR, Smolen JS, Burmeater GR, Bijlsma JWJ, et al. Updated consensus statement on biological agents, specifically tumor necrosis factor a (TNFec) blocking agents and interleukin-1 receptor antagonist (IL-lra), for the treatment of rheumatic diseases, 2005 . Ann Rheum Dis 2005 ;64:iv2-iv 14 . Ledingham J , Deighton C. Update on the British Society for Ftheu-matology guidelines for prescribing TNFec blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001) . Ftheumatology 2005 ; 44 : 157 – 63 . Google Scholar Crossref Search ADS WorldCat Japan College of Ftheumatology, Official Guidelines for the use of anti-TNF agents for rheumatoid arthritis ( in Japanese). https : // www. r yuma chi -jp. com/Ryumachi/S e cur e/k aiin/me di c al/b rm_ guideline.html Arnett FC , Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised cri-teria for the classification of rheumatoid arthritis . Arthritis Rheum 1988 ; 31 : 315 – 24 . Google Scholar Crossref Search ADS PubMed WorldCat Study Group of the Ministry of Health, Labour and Welfare . Diag-nostic and therapeutic manual of rheumatoid arthritis. Diagnostic manual and evidence-based treatment guidelines (in Japanese). Japan Rheumatism Foundation; 2004 . McCurry J . Japan deaths spark concerns over arthritis drug . Lancet 31. 2004 ; 363 : 461 . Google Scholar Crossref Search ADS WorldCat Sakai F , Noma S, Kurihara Y, Yamada H,Azuma A, Kudoh S, et al. Leflunomide-related lung injury in patients with rheumatoid 32. arthritis : imaging features. Mod Ftheumatol 2005 ; 15: 173 – 9 . Ogawa J , Harigai M, Nagasaka K, Nakamura T, Miyasaka N. Predic-tion of and prophylaxis against Pneumocystis pneumonia in patients with connective tissue diseases undergoing medium- or high-dose 33. corticosteroid therapy. Mod Ftheumatol 2005 ; 15: 91 – 6 . Google Scholar OpenURL Placeholder Text WorldCat Obayashi T , Yoshida M, Mori T, Goto H, Yasuoka A, Iwasaki H, et al. Plasma (13)-3-glucan measurement in diagnosis of invasive 34 . deep mycosis and fungi febrile episodes. Lancet 1995 ; 345 : 17 – 20 . Google Scholar OpenURL Placeholder Text WorldCat Yasuoka A , Tachikawa N, Shimada K, Kimura S, Oka S. (1 3) P-D-glucan as a quantitative serological marker for Pneumocystis carinii 35. pneumonia. Clin Diagn Lab Immnunol 1996 ; 3: 197 – 9 . Google Scholar Crossref Search ADS WorldCat Saito K , Nakayamada S, Nakano K, Tokunaga M, Tsujimura S, Nakatsuka K, et al. Detection of Pneumocystis carinii by DNA amplification in patients with connective tissue diseases: re-evaluation of clinical features of P carinii pneumonia in rheumatic diseases . Ftheumatology 2004 ; 43 : 479-85 . 36 . Google Scholar OpenURL Placeholder Text WorldCat Calabrese LH , Zein NN, Vassilopoulos D. Hepatitis B virus (HBV) reactivation with immunosuppressive therapy in rheumatic dis-eases: assessment and preventive strategies. Ann Rheum Dis 2006 ; 65 : 983 – 9 . Wallis RS , Broder MS, Wong JY, Hanson ME, Beenhouwer DO. 37. Granulomatous infectious diseases associated with tumor necrosis factor antagonists. Clin Infect Dis 2004 ; 38: 1261 – 5 . Crum NF , Lederman ER, Wallace MR . Infections associated with tumor necrosis factor-a antagonists. Medicine 2005 ; 84 : 291-302 . 38 . Google Scholar OpenURL Placeholder Text WorldCat Mufti AH , Toye BW, Mckendry RRJ, Angel JB. Mycobacterium abscessus infection after use of tumor necrosis factor a inhibitor therapy: case report and review of infectious complications associ- 39 . ated with tumor necrosis factor a inhibitor use. Diagn Microbiol Infect Dis 2005 ; 53 : 233 – 8 . Google Scholar OpenURL Placeholder Text WorldCat Khanna D , McMahon M, Furst DE. Safety of tumour necrosis 40. factor-a antagonists. Drug Safety 2004 ; 27: 307 – 24 . Benson CA , Kaplan JE, Masur H, Pau A, Holmes KK. Treating opportunistic infections among HIV-infected adults and adoles-cents. Recommendations from CDC, the National Institutes of 41. Health, and the HIV Medicine Associated Diseases Society of America. MMWR 2004 ;53(RR15): 1 – 112 . Chung ES , Packer M, Lo KH, Fasanmade AA, Willerson JT. 42. Randomized, double-blind, placebo-controlled, pilot trial of inflix-imab, a chimeric monoclonal antibody to tumor necrosis factor-a, in patients with moderate-to-severe heart failure. Results of the anti-TNF therapy against congestive heart failure (ATTACH) trial. Circulation 2003 ; 107: 3133–40.43 . Kwon HJ , Cote TR, Cuffe MS, Kramer JM, Braun MM. Case reports of heart failure after therapy with a tumor necrosis factor 44. antagonist. Ann Intern Med 2003 ; 138: 807 – 12 . 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 45. study. Neurology 1999 : 53: 457 – 65 . Mohan N , Edwards ET, Cupps TR, Oliverio PJ, Sandberg G, Crayton H, et al. Demyelination occurring during anti-tumor necrosis factor a therapy for inflammatory arthritides . Arthritis 46. Rheum 2001 ; 44 : 2862 – 9 . Google Scholar Crossref Search ADS WorldCat Jarand J , Zochodne DW, Martin LO,Voll C . Neurological complica-tions of infliximab. J Ftheumatol 2006 ; 33 : 1018 – 20 . Google Scholar OpenURL Placeholder Text WorldCat Carswell EA , Old LJ, Kassel RL, Green S, Fiore N, Williamson B. 47. An endotoxin-induced serum factor that causes necrosis of tumors. Proc Nat Acad Sci USA 1975 ; 72: 3666 – 70 . Bendtzen K , Geborek P, Svenson M, Larsson L, Kapetanovic MC, 48 . Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor a inhibitor infliximab. Arthritis Rheum 2006 ; 54 : 3782-9 . 49 . Google Scholar OpenURL Placeholder Text WorldCat Klareskog L , Van der Heijde D, De Jager JP, Gough A, Kalden J, Malaise M, et al. Therapeutic effect of the combination of etaner-cept and methotrexate compared with each treatment alone in 50. patients with rheumatoid arthritis : double-blind randomised con-trolled trial. Lancet 2004 ; 363: 675 – 81 . Doran MF , Crowson CS, Pond GR, O'Fallon WM, Gabrial SE . Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002 ; 46 : 2294 – 300 . Google Scholar Crossref Search ADS WorldCat Wolfe F , Caplan L, Michaud K . Treatment of rheumatoid arthritis and the risk of hospitalization for pneumonia. Association with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy. Arthritis Rheum 2006 ; 54 : 628 – 34 . Google Scholar OpenURL Placeholder Text WorldCat Kroesen S , Widmer AF, Tyndall A, Hasler P. Serious bacterial infections in patients with rheumatoid arthritis under anti-TNF-� therapy . Rheumatology 2003 ; 42 : 617 – 21 . 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Journal

Modern Rheumatology – Oxford University Press

Published: Dec 1, 2007

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