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Review

Safety and efficacy of disease-modifying antirheumatic agents in rheumatoid arthritis and juvenile rheumatoid arthritis

Roy Fleischmann University of Texas Southwestern Medical Center at Dallas, St Paul University Hospital, 5939 Harry Hines Boulevard, Suite 400, Dallas, Texas 75235, USA. [email protected]
Pages 347-365 | Published online: 03 Mar 2005

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  • •This article reviews in depth the comparative efficacy and toxicity of traditional DMARDs. It points out that many patients do not benefit from monotherapy of these DMARDs either because of the development of toxicity relatively early on in therapy or because the medications lose efficacy within 1–2 years.
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  • •This is the seminal article on the use of MIX
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  • •This article demonstrates that MTX, when properly dosed and when followed closely for the development of significant AEs, can be used for many years with efficacy and safety.
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  • •The conclusions of this article are that virtually all traditional DMARDs have limited long-term benefit because of toxicity and loss of efficacy issues.
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  • •This study compares leflunomide with MTX and placebo and demonstrates that both medications are superior to placebo but also points out that neither medication is maintained in patients for > 1 year.
  • NORDSTROM DM, WEST SG, ANDERSEN PA, SHARP JT: Pulse methotrexate therapy in rheumatoid arthritis. A controlled prospective roentgenographic study. Ann. Intern. Med. (1987) 107(6):797–801.
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  • JEURISSEN ME, BOERBOOMS AM, VAN DE PUTTE LB et al: Influence of methotrexate and azathioprine on radiologic progression in rheumatoid arthritis. A randomized, double blind study. Ann. Intern. Med. (1991) 114(12):9994004.
  • RAU R, HERBORN G, KARGER T, WERDIER D: Retardation of radiologic progression in rheumatoid arthritis with methotrexate therapy. A controlled study. Arthritis Rheum. (1991) 34(10):1236–1244.
  • WEINBLATT ME, POLISSON R, BLOTNER SD et al: The effects of drug therapy on radiographic progression of rheumatoid arthritis. Results of a 36-week randomized trial comparing methotrexate and auranofin. Arthritis Rheum. (1993) 36(5):613–619.
  • LOPEZ-MENDEZ A, DANIEL WW, READING JC et al.: Radiographic assessment of disease progression in rheumatoid arthritis patients enrolled in the cooperative systematic studies of the rheumatic diseases program randomized clinical trial of methotrexate, auranofin, or a combination of the two. Arthritis Rheum. (1993) 36(10):1364–1369.
  • SHARP JT, STRAND V, LEUNG H et ed.:Treatment with leflunomide slows radiographic progression of rheumatoid arthritis: results from three randomized controlled trials of leflunomide in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum. (2000) 43(3):495–505.
  • •This article demonstrates that both leflunomide and MTX retard radiographic progression.
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  • FELSON DT, ANDERSON JJ, MEENAN RF: Use of short-term efficacy/toxicity tradeoffs to select second-line drugs in rheumatoid arthritis. A meta-analysis of published clinical trials. Arthritis Rheum. (1992) 35(10):1117–1125.
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  • MLADENOVIC V, DOMLJAN Z, ROZMAN B et al.: Safety and effectiveness of leflunomide in the treatment of patients with active rheumatoid arthritis. Results of a randomized, placebo-controlled, Phase II study. Arthritis Rheum. (1995) 38(11):1595–1603.
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  • SCOTT DL, SMOLEN JS, KALDEN JR et al.: Treatment of active rheumatoid arthritis with leflunomide: two year follow-up of a double blind, placebo controlled trial versus sulfasalazine. Ann. Rheum. Dis. (2001) 60:913–923.
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  • •The retardation of radiological progression with leflunomide and sulfasalazine is shown in this report.
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  • KREMER JM, GENOVESE MC, CANNON GW et al.: Concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate. A randomized, double-blind, placebo-controlled trial. Ann. Intern. Med. (2002) 137:726–733.
  • •This well-performed study demonstrated that the combination of leflunomide and MTX is more efficacious than MTX alone in MTX partial responders, but also points out the significant risk of elevated liver function tests with the combination.
  • BOERS M, VERHOEVEN AC, MARKUSSE HM et al.: Randomized comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet (1997) 350:309–318.
  • •This is the first demonstration of the early aggressive use of combination therapy, and the results showed impressive control of disease with this combination which was maintained.
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  • DINARELLO CA, MOLDAWER LL: Proinjiammatory and Anti-Inflammatory Cytokines in Rheumatoid Arthritis: A Primer for Clinicians (3rd edn). Amgen, Inc., Thousand Oaks, CA (2001).
  • BRESNIHAN B, ALVARO-GARCIA JM,COBBY M et al: Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum. (1998) 41(12):2196–2204.
  • •This is the first demonstration of the effectiveness of anakinra in RA.
  • NUKI G, BRESNIHAN B, BEAR M, MCCABE D: Long-term safety and maintenance of clinical improvement following treatment with anakinra (recombinant human interleukin-1 receptor antagonist) in patients with rheumatoid arthritis. Arthritis Rheum. (2002) 46(11):2838–2846.
  • JIANG Y, GENANT HK, WATT I et al.: A multicenter, double-blind, dose ranging, randomized, and placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radiological progression and correlation of Genant and Larsen scores. Arthritis Rheum. (2000) 43:1001–1009.
  • •This is the first demonstration of the retardation of radiographic progression with anakinra.
  • COHEN SB, HURD E, CUSH JJ et aL: Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 antagonist, in combination with methotrexate. Arthritis Rheum. (2002) 46:614–624.
  • SHERGY WJ, COHEN SB, GREENWALD M et aL: Anakinra (Kineret°) inhibits the progression of radiographically measured joint destruction in rheumatoid arthritis. Am. ColL RheumatoL (October 2002). Abstract.
  • REIFF A, PORRAS O, RUDGE S et aL: Preliminary data from a study of Kinererrm (anakinra) in children with juvenile rheumatoid arthritis. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 496.
  • KNIGHT DM,TRINH H, LE J et aL: Construction and initial characterization of mouse human chimeric anti-TNF-a antibody. MoL Immunol. (1993) 30:1443–1453.
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  • ELLIOTT MJ, MAINI RN, FELDMANN M et aL: Treatment of RA with chimeric monoclonal antibody to TNF-a. Arthritis Rheum. (1993) 36:1681–1690.
  • ELLIOTT MJ, MAINI RN, FELDMANN M et aL: Randomized double-blind comparison of chimeric monoclonal antibody to TNF-a CA2 versus placebo in RA. Lancet (1994) 344:1105–1110.
  • •This is the first demonstration of the effectiveness of inffiximab, and also points out that low-dose MTX is required to limit the development of HACAs.
  • WAGNER CL, ST CLAIR EW, HAN C et aL: Effects of antibodies to inffiximab on ACR response in patients with rheumatoid arthritis in the ATTRACT study. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 260.
  • MAINI RN, BREED VELD FC, KALDEN JR et al.: Therapeutic efficacy of multiple IV infusions of anti-TNF-a monoclonal antibody combined with low dose weekly methotrexate in RA. Arthritis Rheum. (1998) 41:1552–1563.
  • MAINI RN, ST CLAIRE WILLIAM, BREEDVELD FC et aL: Inffiximab versus placebo in RA patients receiving concomitant methotrexate: a randomized Phase III trial. Lancet (1999) 354:1932–1939.
  • LIPSKY PE, VAN DER HEIJDE DMFM, ST CLAIR EW et al.: Inffiximab and methotrexate in the treatment of rheumatoid arthritis. N EngL J. Med. (2000) 343:1594–1602.
  • •This is the seminal article on the use of inffiximab plus MTX in RA both for clinical signs and symptoms and retardation of X-ray progression.
  • LIPSKY PE, VAN DER HEIJDE DMFM, ST CLAIR EW et aL: 102-week clinical and radiologic results from the ATTRACT trial: a 2 year, randomized, controlled, Phase III trial of inffiximab (Remicade) in patients with active RA despite MTX. Arthritis Rheum. (2000) 43(9). Abstract 1216.
  • QUINN M: Rapid and sustained improvement with TNF blockade in early rheumatoid arthritis: results from a double blind placebo controlled study with MRI outcomes. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 1388.
  • QUINN MA, CONAGHAN PG, GREENSTEIN A et al.: Sustained response in early poor prognosis RA after withdrawal of inffiximab therapy. Am. ColL RheumatoL (October 2002). Abstract.
  • HONKANEN VE, TYNJALA P, VAHASALO P, LAHDENNE P: Inffiximab in juvenile arthritis: 1-year follow-up. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 1272.
  • NAM MH, REDA D, BOUJOUKOS AJ et aL: Recombinant human dimeric tumor necrosis factor (TNF) receptor (TNFR:Fc): safety and pharmacokinetics in human volunteers. Clin. Res. (1993) 41(2):249A. Abstract.
  • MORELAND LW, MARGOLIES G, HECK LW et aL: Recombinant soluble tumor necrosis factor receptor (p80) fusion protein: toxicity and dose finding trial in refractory rheumatoid arthritis. J. Rheum. (1996) 23:1849–1855.
  • MORELAND LW, BAUMGARTNER SW, SCHIFF MH et aL: Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor (p75)-Fc fusion protein. N EngL J. Med. (1997) 17(337):141–147.
  • •This is the first demonstration of the efficacy of etanercept in RA.
  • MORELAND LW, SCHIFF, MH, BAUMGARTNER SW et al.: Etanercept therapy in rheumatoid arthritis: a randomized, controlled study. Ann. Intern. Med. (1999) 130:478–486.
  • MORELAND LW, COHEN SB, FLEISCHMANN RM et aL: Safety and efficacy of up to 5 years of etanercept (Enbrel) therapy in rheumatoid arthritis. Ann. Rheum. Dis. (2002) 61(1). Abstract FRI0078.
  • WEINBLATT ME, KREMER JM, BANKHURST AD et aL: A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N EngL J. Med. (1999) 340:253–259.
  • •This is the first demonstration of the efficacy of the combination of etanercept and MTX.
  • KREMER J, WEINBLATT M, FLEISCHMANN R et aL: Etanercept (Enbrel) added to background methotrexate in rheumatoid arthritis: continued observations. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 1421.
  • BATHON JM, MARTIN RW, FLEISCHMANN RM et aL: A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N EngL J. Med. (2000) 343:1586–1593.
  • •This is the first study in which the aggressive use of MTX was employed in early RA and demonstrates the increased effectiveness of MTX in this situation as well as the utility of etanercept in early RA. The retardation of structural damage with both agents is also shown.
  • GENOVESE M, BATHON J, MARTIN R et aL: Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. (2002) 46(6):1443–1451.
  • •This reports demonstrates that etanercept in early RA is more effective than
  • BATHON JM, GENOVESE MC, MARTIN RW et al.: Etanercept (Enbrel) in early erosive rheumatoid arthritis (ERATrial): observations at three years. Ann. Rheum. Dis. (2002) 61(1). Abstract 0P0072.
  • FLEISCHMANN R, BAUMGARTNER S, MORELAND Let al.: Patient reported outcomes (PRO) in rheumatoid arthritis (RA) patients treated with etanercept (Enbrel) for up to 5 years. Arthritis Rheum. (2002) 46(9). Abstract 1420.
  • •This reports shows that the early,
  • LOVELL DJ, GIANNINI EH, REIFF A et al.: Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Engl. J. Med. (2000) 342:763–769.
  • •The effectiveness of etanercept in polyarticular arthritis in children is shown.
  • GIANNINI EH, RUPERTO N, RAVELLI A et al.: Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum. (1997) 40:1202–1209.
  • LOVELL DJ, GIANNINI EH, REIFF A et al.: Long-term efficacy and saefty of etanercept in children with poly-articular course juvenile rheumatoid arthritis. Arthritis Rheum. (2003) 48(1):218–226.
  • SALFELD J, KAYMAKCALAN Z, TRACEY D et al.: Generation of fully human anti-TNF antibody D2E7. Arthritis Rheum. (1998) 41(9):S57. Abstract.
  • VAN DE PULTE LB, ATKINS C, MALAISE M et al.: Adalimumab (D2E7) monotherapy in the treatment of patients with severely active rheumatoid arthritis. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 467.
  • •The effectiveness of adalimumab in DMARD failures is shown in this report.
  • BURMEISTER GR, VAN DE PULTE, RAU R et al.: Long-term efficacy and safety of adalimumab (D2E7) monotherapy in patients with DMARD refractory rheumatoid arthritis - results from a 2-year study. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 1436.
  • RAU R, SIMLANER S, WEIER R et al.: Effective combination of the fully human anti-TNF antibody D2E7 and methotrexate in active rheumatoid arthritis. XIV European League Against Rheumatism (PULAR) Congress, Glasgow (June 1999). Ann. Rheum. Dis.
  • SIMLANER S, RAU, R, WASSENBERG S et al.: 1-year treatment results of the fully human anti-TNF antibody D2E7 in combination with methotrexate in active rheumatoid arthritis. XIV European League Against Rheumatism (PULAR) Congress, Nice (June 2000). Ann. Rheum. Dis.
  • WEINBLATT M, KEYSTONE E, FURST D et al.: Adalimumab, a fully human anti-tumor necrosis factor-a monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA Trial. Arthritis Rheum. (2003) 48:35–45.
  • •The effectiveness of adalimumab in patients with an incomplete response to MTX is shown in this report.
  • KAVANAUGH A, WEINBLATT M, KEYSTONE E et al.: The ARMADA trial: 12-month efficacy and safety of combination therapy with adalimumab (D2E7), the first fully human anti-TNF-a monoclonal antibody and methotrexate (MTX) in patients with active rheumatoid arthritis. Ann. Rheum. Dis. (2002) 61(1). Abstract FRI0026.
  • KEYSTONE E, KAVANAUGH A, SHARP J et al.: 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. (2002) 46(9 Suppl.). Abstract 468.
  • •This report demonstrates the retardation of structural damage with adalimumab in combination with MTX
  • RICHTER JA, RUNGE LA, FINALS RS et al.: Analysis of treatment terminations with gold and antimalarial compounds in rheumatoid arthritis. J. Rheumatol (1980) 7:153–159.
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  • SANDOVAL DM, ALARCON GS, MORGAN SL: Adverse events in methotrexate-treated rheumatoid arthritis patients. Br. J. Rheumatol. (1995) 34:49–56.
  • BROOKS P: Disease-modifying antirheumatic drugs. In: Primer on the Rheumatic Disease (11th edn). Arthritis Foundation, Atlanta, Georgia (1997):432–436.
  • CANNON GW, SCHIFF M, STRAND V et al.: Hepatic adverse events and other toxicity during treatment with leflunomide (LEF), methotrexate (MTX), other disease modifying anti-rheumatic drugs (DMARDs), and combination DMARD therapy: comparison to NSAIDs alone and adjustment for comorbidities. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 1440.
  • WOLFE F: Low rates of serious liver toxicity to leflunomide (LEF) and methotrexate (MTX): a longitudinal surveillance study of 14,997 LEF and MTX exposures in RA. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 968.
  • FLEISCHMANN R, SCHECHTMAN J, BENNETT R et al.: A large, international, multicenter, placebo-controlled trial of anakinra, a recombinant interleukin-1 receptor antagonist (r-metHuIl-lra), in patients with rheumatoid arthritis. Arthritis Rheum. (2003). In Press.
  • •This is the largest safety trial of a BRM in RA in patients with a number of comorbidities and concomitant medications.
  • FLEISCHMANN R: Safety of anakinra, a recombinant interleukin-1 receptor antagonist (r-metHuIL-lra), in patients with rheumatoid arthritis and comparison to anti-TNF-a agents. Clin. Exp. Rheumatol (2002) (Suppl. 27):535–541.
  • DORAN MF, CROWSON CS, POND GR et al.: Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. (2002) 46:2287–2293.
  • •This report points out that patients with RA are at an increased risk for serious infections even without the use of BRMs.
  • SCHIFF M, BULPITT K, WEAVER A et al.: Safety of combination therapy with Kineret (anakinra) and etanercept in patients with rheumatoid arthritis. Ann. Rheum. Dis. (2002) 61(1). Abstract FRI0083.
  • •This report shows that the combination of anakinra and etanercept does produce a significant increase in serious infections.
  • Remicade® (infliximab) package insert. Centocor, Inc. (2002).
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  • •This report shows that etanercept over 5 years has a reasonable safety profile.
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  • HOLMAN J, WALLIS WJ, SABATH DF, VIVEASH D, BURGE DJ: Tuberculosis reports with etanercept (Enbrel®) therapy. Ann. Rheum. Dis. (2002) 61\(Suppl. 1):167–168. Abstract.
  • MORELAND LW, BUCY RP, WEINBLATT ME et al.: Effects of TNF receptor (P75) fusion protein (TNFR:Fc; Enbrel) on immune function. Arthritis Rheum. (1998) 41(Suppl.):S59. Abstract 158.
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  • HumiraTm (adalimumab) package insert. Abbott Laboratories (2003).
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  • BROWN SL, GREENE MH, GERSHON SK et al.: Tumor necrosis factor antagonist therapy and lymphoma development. Arthritis Rheum. (2002) 46(12):3151–3158.
  • •This report points out the risk of lymphoma with anti-TNF agents.
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  • KEANE J, GERSHON S, WISE RP et al: Tuberculosis associated with infliximab, a tumor necrosis factor-a-neutralizing agent. N Engl. J. Med. (2001) 345(15):1098–1104.
  • •This reports points out the risk of tuberculosis with anti-TNF agents.
  • KEYSTONE E: Update on Biologics. Presented at EULAR, Stockholm, Sweden (2002).
  • MANADAN AN, MOHAN AK, COTE TR et al: Tuberculosis and etanercept treatment. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 356.
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  • SABATH DF, WALLIS WJ, BURGE DJ et al: Lymphoma reports with etanercept (Enbrel) therapy. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 1426.
  • PETERSON JR: Safety of the TNF-a antagonists in patients with rheumatoid arthritis and chronic hepatitis C. Ann. Rheum. Dis. (2002) 61(1). Abstract OP 0098.
  • MOHAN N, EDWARDS ET, CUPPS TR et al: Demyelination occurring during anti-tumor necrosis factor-a therapy for inflammatory arthritides. Arthritis Rheum. (2001) 44:2862–2869.
  • •This report discusses demyelination with anti-TNF agents.
  • WOOTEN MD, REDDY GV, JOHNSON RD: Atrial fibrillation occurring in a patient taking etanercept plus methotrexate for rheumatoid arthritis. DeL Med. J. (2000) 72(12):517–519.
  • GALARIA NA, WERTH VP, SCHUMACHER HR Leukocytoclastic vasculitis due to etanercept. J. Rheumatol (2000) 27 (8):2041–2044.
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  • RUSSELL E, ZEIHEN M, WERGIN S et al: Patients receiving etanercept may develop antibodies that interfere with monoclonal antibody laboratory assays. Arthritis Rheum. (2000) 43:944.
  • QUARTIER P, TUAPIN P, BOURDEAUT F et al: Efficacy of etanercept for the treatment of juvenile isdiopathic arthritis according to the onset type. Aythitis Rheum (2003) 48(4):1093–1101.
  • WALLIS WJ, SABATH DF, DO TP et al: Update on comparative benefit/risk analysis of DMARD therapies. Arthritis Rheum. (2002) 46(9 Suppl.). Abstract 144.
  • FLEISCHMANN RM: Examining the efficacy of biologic therapy: are there real differences? J. Rheum. (2002) 29(565):27–32.
  • •This reports discusses many of the reasons why efficacy trials cannot be compared.
  • FLEISCHMANN RM, BAUMGARTNER SW, MORELAND LW et al: Improvement in disability in RA patients with early versus established disease treated with enbrel. Ann. Rheum. Dis. (2001) 60(Suppl.):172. Abstract FRI081.

Websites

  • http://www.fda.govllohrms/dockets/ados/ briefing/393061.htm FDA Briefing Information (4 March 2003).
  • •This is an excellent review of the efficacy and toxicity of adalimumab, etanercept and inffiximab.
  • http://www.emea.eu.int/pclfi/human/press/pus/ 56110en.pdf EMEA Public Statement on Leflunomide (Arava) — severe and serious hepatic reactions. The European Agency for the Evaluation of Medicinal Products (12 March 2001).
  • http://www.fda.gov/ohrms/dockets/ac/01/ briefing/377961b1_01_Amgen.pclf Kineret (analcinra) FDA Briefing Information (16 August 2001).
  • http://seer.cancer.gov/csr/ 191973_1999/,2002 SEER Cancer Statistics Review, 1973 — 1999. Ries LAG, Eisner MP, Kosary CL et al. (Eds), National Cancer Institute, Bethesda, MD.
  • http://www.fda.gov/medwatch/SAFETY/ 2001 /remicadeTB_deardoc. pdf Important drug warning. Centocor, Inc. (2001).

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