Twelve years’ experience with etanercept in the treatment of rheumatoid arthritis: how it has changed clinical practice

References

• Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet358, 903–911 (2001).
   PubMed Web of Science ®Google Scholar
• Emery P. Early arthritis. In: Targeted Therapies in Rheumatology. Smolen JS, Lipsky PE (Eds). Martin Dunitz, London, UK, 509–513 (2003).
   Google Scholar
• van Dongen H, van Aken J, Lard LR et al. Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial. Arthritis Rheum.56, 1424–1432 (2007).
   PubMed Web of Science ®Google Scholar
• Kirwan JR. Arthritis and rheumatism council low-dose glucocorticoid study group: the effect of glucocorticoids on joint destruction in rheumatoid arthritis. N. Engl. J. Med.333, 142–114 (1995).
   PubMed Web of Science ®Google Scholar
• Nell VP, Machold KP, Eberl G, Stamm TA, Uffmann M, Smolen JS. Benefit of very early referral and very early therapy with disease-modifying anti-rheumatic drugs in patients with early rheumatoid arthritis. Rheumatology (Oxford)43, 906–914 (2004).
   PubMed Web of Science ®Google Scholar
• van der Heijde D. Radiographic progression in rheumatoid arthritis: does it reflect outcome? Does it reflect treatment? Ann. Rheum. Dis.60(Suppl. 3), iii47–iii50 (2001).
   PubMed Web of Science ®Google Scholar
• Zink A, Strangfeld A, Schneider M et al. Effectiveness of tumor necrosis factor inhibitors in rheumatoid arthritis in an observational cohort study: comparison of patients according to their eligibility for major randomized clinical trials. Arthritis Rheum.54, 3399–3407 (2006).
   PubMed Web of Science ®Google Scholar
• Caporali R, Pallavicini FB, Filippini M et al. Treatment of rheumatoid arthritis with anti-TNF-alpha agents: a reappraisal. Autoimmun. Rev.8, 274–280 (2009).
   PubMed Web of Science ®Google Scholar
• Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N. Engl. J. Med.344, 907–916 (2001).
   PubMed Web of Science ®Google Scholar
• Wiens GD, Glenney GW. Origin and evolution of TNF and TNF receptor superfamilies. Dev. Comp. Immunol.35(12), 1324–1335 (2011).
   PubMedGoogle Scholar
• Pincus T, Furer V, Keystone E, Yazici Y, Bergman MJ, Luijtens K. RAPID3 (Routine assessment of patient index data 3) severity categories and response criteria: Similar results to DAS28 (disease activity score) and CDAI (clinical disease activity index) in the RAPID 1 (rheumatoid arthritis prevention of structural damage) clinical trial of certolizumab pegol. Arthritis Care Res.63(8), 1142–1149 (2011).
   PubMed Web of Science ®Google Scholar
• Ash Z, Emery P. Golimumab – a new tool in the armoury against inflammatory arthritis. Ann. Med.43(2), 133–141 (2011).
   PubMed Web of Science ®Google Scholar
• Daudén E. Chemical structure of etanercept, pharmacokinetics and mechanism of action. Actas Dermosifiliogr.101(Suppl. 1), 1–4 (2010).
   Google Scholar
• Combe B. Update on the use of etanercept across a spectrum of rheumatoid disorders. Biologics2, 165–173 (2008).
   PubMedGoogle Scholar
• Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol. Ther.117(2), 244–279 (2008).
   PubMed Web of Science ®Google Scholar
• Zhou H. Clinical pharmacokinetics of etanercept: a fully humanized soluble recombinant tumor necrosis factor receptor fusion protein. J. Clin. Pharmacol.45, 490–497 (2005).
   PubMed Web of Science ®Google Scholar
• Nestorov I. Clinical pharmacokinetics of TNF antagonists: how do they differ? Semin Arthritis Rheum.34, 12–18 (2005).
   PubMed Web of Science ®Google Scholar
• Nestorov I. Clinical pharmacokinetics of tumor necrosis factor antagonists. J. Rheumatol.74(Suppl.), 13–18 (2005).
   Google Scholar
• Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci.93, 2645–2668 (2004).
   PubMed Web of Science ®Google Scholar
• 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.340, 253–259 (1999).
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Klareskog L, Rodriguez-Valverde V et al. TEMPO study investigators. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum.54, 1063–1074 (2004).
   Google Scholar
• Keystone E, Freundlich B, Schiff M, Li J, Hooper M. Patients with moderate rheumatoid arthritis (RA) achieve better disease activity states with etanercept treatment than patients with severe RA. J. Rheumatol.36(3), 522–531 (2009).
   PubMed Web of Science ®Google Scholar
• van Riel PL, Taggart AJ, Sany J et al. Add Enbrel or Replace Methotrexate Study Investigators. Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study. Ann. Rheum. Dis.65(11), 1478–1483 (2006).
   PubMed Web of Science ®Google Scholar
• Kameda H, Kanbe K, Sato E et al. Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from the JESMR study. J. Rheumatol.38, 1585–1592 (2011).
   PubMed Web of Science ®Google Scholar
• Wiens A, Venson R, Correr CJ, Otuki MF, Pontarolo R. Meta-analysis of the efficacy and safety of adalimumab, etanercept, and infliximab for the treatment of rheumatoid arthritis. Pharmacotherapy30(4), 339–353 (2010).
   PubMed Web of Science ®Google Scholar
• Hyrich KL, Symmons DP, Watson KD, Silman AJ; British Society for Rheumatology Biologics Register. Comparison of the response to infliximab or etanercept monotherapy with the response to cotherapy with methotrexate or another disease-modifying antirheumatic drug in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum.54, 1786–1794 (2006).
   PubMed Web of Science ®Google Scholar
• Listing J, Strangfeld A, Rau R et al. Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low – results from RABBIT, the German biologics register. Arthritis Res. Ther.8(3), R66 (2006).
   PubMed Web of Science ®Google Scholar
• Arenere Mendoza M, Manero Ruiz FJ, Carrera Lasfuentes P, Navarro Aznárez H, Pecondón Español A, Rabanaque Hernández MJ. Tumour necrosis factor alpha antagonists in established rheumatoid arthritis: Effectiveness comparative study. Med. Clin.134, 665–670 (2010).
   PubMedGoogle Scholar
• Jin J, Chang Y, Wei W. Clinical application and evaluation of anti-TNF-alpha agents for the treatment of rheumatoid arthritis. Acta Pharmacol. Sin.31(9), 1133–1140 (2010).
   PubMedGoogle Scholar
• Bathon JM, Martin RW, Fleischmann RM et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N. Engl. J. Med.343, 1586–1593 (2000).
   PubMed Web of Science ®Google Scholar
• Genovese MC, Bathon JM, Martin RW et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum.46, 1443–1450 (2002).
   PubMed Web of Science ®Google Scholar
• Genovese MC, Bathon JM, Fleischmann RM et al. Long-term safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J. Rheumatol.32, 1232–1242 (2005).
   PubMed Web of Science ®Google Scholar
• Emery P, Breedveld FC, Hall S et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet372, 375–382 (2008).
   PubMed Web of Science ®Google Scholar
• Kekow J, Moots RJ, Emery P et al. Patient-reported outcomes improve with etanercept plus methotrexate in active early rheumatoid arthritis and the improvement is strongly associated with remission: the COMET trial. Ann. Rheum. Dis.69, 222–225 (2010).
   PubMed Web of Science ®Google Scholar
• Kekow J, Moots R, Khandker R, Melin J, Freundlich B, Singh A. Improvements in patient-reported outcomes, symptoms of depression and anxiety, and their association with clinical remission among patients with moderate-to-severe active early rheumatoid arthritis. Rheumatology (Oxford)50, 401–409 (2011).
   PubMed Web of Science ®Google Scholar
• Koyama Y, Shiraishi H, Ohta T, Uchino A. Etanercept in combination with conventional disease-modifying antirheumatic drugs (DMARDs) in the treatment of rheumatoid arthritis patients intolerant to methotrexate. Mod. Rheumatol. doi:10.1007/s10165-011-0478-8 (2011) (Epub ahead of print).
   Google Scholar
• Benucci M, Saviola G, Baiardi P, Manfredi M, Sarzi-Puttini P, Atzeni F. Efficacy and safety of leflunomide or methotrexate plus subcutaneous tumour necrosis factor-alpha blocking agents in rheumatoid arthritis. Int. J. Immunopathol. Pharmacol.24(1), 269–274 (2011).
   PubMed Web of Science ®Google Scholar
• Hetland ML, Christensen IJ, Tarp U et al. All departments of rheumatology in Denmark. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum.62(1), 22–32 (2010).
   PubMed Web of Science ®Google Scholar
• Marchesoni A, Zaccara E, Gorla R et al. TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann. NY Acad. Sci.1173, 837–846 (2009).
   PubMed Web of Science ®Google Scholar
• Geborek P, Crnkic M, Petersson IF, Saxne T; South Swedish Arthritis Treatment Group. Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden. Ann. Rheum. Dis.61(9), 793–798 (2002).
   PubMed Web of Science ®Google Scholar
• Klareskog L, Gaubitz M, Rodríguez-Valverde V, Malaise M, Dougados M, Wajdula J. Etanercept study 301 investigators. Assessment of long-term safety and efficacy of etanercept in a 5-year extension study in patients with rheumatoid arthritis. Clin. Exp. Rheumatol.29, 238–247 (2011).
   PubMed Web of Science ®Google Scholar
• Moots RJ, Haraoui B, Matucci-Cerinic M et al. Differences in biologic dose-escalation, non-biologic and steroid intensification among three anti-TNF agents: evidence from clinical practice. Clin. Exp. Rheumatol29, 26–34 (2011).
   PubMed Web of Science ®Google Scholar
• Thalayasingam N, Isaacs JD. Anti-TNF Therapy. Best Pract. Res. Clin. Rheumatol.25, 549–567 (2011).
   PubMed Web of Science ®Google Scholar
• Dixon WG, Watson K, Lunt K et al. British Society for Rheumatology Biologics Register Control Centre Consortium, Silman AJ, Symmons DPM. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy. Arthritis Rheum.54, 2368–2376 (2006).
   PubMed Web of Science ®Google Scholar
• Dixon WG, Hyrich KL, Watson KD et al. BSRBR Control Centre Consortium, Symmons DP, BSR Biologics Register. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann. Rheum. Dis.69, 522–528 (2010).
   PubMed Web of Science ®Google Scholar
• Galloway JB, Hyrich KL, Mercer LK et al. BSRBR Control Centre Consortium; British Society for Rheumatology Biologics Register. Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology (Oxford).50, 124–131 (2011).
   PubMed Web of Science ®Google Scholar
• Askling J, Fored CM, Brandt L et al. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann. Rheum. Dis.66, 1339–1344 (2007).
   PubMed Web of Science ®Google Scholar
• Listing J, Strangfeld A, Kary S et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum.52, 3403–3412 (2005).
   PubMed Web of Science ®Google Scholar
• Tubach F, Salmon D, Ravaud P et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: the three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum.60(7), 1884–1894 (2009).
   PubMed Web of Science ®Google Scholar
• Dixon WG, Hyrich KL, Watson KD et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann. Rheum. Dis.69(3), 522–528 (2010).
   PubMed Web of Science ®Google Scholar
• Atzeni F, Biasi D, Botsios C et al. Long-term anti-TNF therapy and risk of serious infections in a cohort of patients with rheumatoid arthritis: comparison among adalimumab, etanercept and infliximab. Ann. Rheum. Dis.70(Suppl. 3), abstract 229 (2011).
   Google Scholar
• Strangfeld A, Listing J, Herzer P et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents. JAMA301, 737–744 (2009).
   PubMed Web of Science ®Google Scholar
• Galloway JB, Hyrich KL, Mercer LK et al. BSR Biologics Register. Risk of septic arthritis in patients with rheumatoid arthritis and the effect of anti-TNF therapy: results from the British Society for Rheumatology Biologics Register. Ann. Rheum. Dis.70, 1810–1814 (2011).
   PubMed Web of Science ®Google Scholar
• Keystone EC. Does anti-tumor necrosis factor-{alpha} therapy affect risk of serious infection and cancer in patients with rheumatoid arthritis?: a review of longterm data. J. Rheumatol.38, 1552–1562 (2011).
   PubMed Web of Science ®Google Scholar
• Bordas X, Martín-Sala S. Etanercept and chronic infection by HCV and HBV. Actas Dermosifiliogr.101(Suppl. 1), 82–87 (2010).
   PubMedGoogle Scholar
• Brunasso AM, Puntoni M, Gulia A, Massone C. Safety of anti-tumour necrosis factor agents in patients with chronic hepatitis C infection: a systematic review. Rheumatology50(9), 1700–1711 (2011).
   PubMed Web of Science ®Google Scholar
• Caporali R, Bobbio-Pallavicini F, Atzeni F et al. Safety of tumor necrosis factor alpha blockers in hepatitis B virus occult carriers (hepatitis B surface antigen negative/anti-hepatitis B core antigen positive) with rheumatic diseases. Arthritis Care. Res.62(6), 749–754 (2010).
   PubMed Web of Science ®Google Scholar
• Wolfe F, Michaud K. The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19,562 patients during 89,710 person-years of observation. Arthritis Rheum.56(5), 1433–1439 (2007).
   PubMed Web of Science ®Google Scholar
• Askling J, Fored CM, Baecklund E et al. Haematopoietic malignancies in rheumatoid arthritis: lymphoma risk and characteristics after exposure to tumour necrosis factor antagonists. Ann. Rheum. Dis.64, 1414–1420 (2005).
   PubMed Web of Science ®Google Scholar
• 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. Ann. Rheum. Dis64, 1421–1426 (2005).
   PubMed Web of Science ®Google Scholar
• Mariette X, Matucci-Cerinic M, Pavelka K et al. Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis. Ann. Rheum. Dis.70(11), 1895–1904 (2011).
   PubMed Web of Science ®Google Scholar
• Mann DL, McMurray JJ, Packer M et al. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomised Etanercept World-wide Evaluation (RENEWAL). Circulation109, 1594–1602 (2004).
   PubMed Web of Science ®Google Scholar
• Jacobsson LT, Turesson C, Gülfe A et al. Treatment with tumor necrosis factor blockers is associated with a lower incidence of first cardiovascular events in patients with rheumatoid arthritis. J. Rheumatol.32, 1213–1218 (2005).
   PubMed Web of Science ®Google Scholar
• Dixon WG, Watson KD, Lunt M et al. Reduction in the incidence of myocardial infarction in patients with rheumatoid arthritis who respond to anti-tumor necrosis factor α therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum.56(9), 2905–2912 (2007).
   PubMed Web of Science ®Google Scholar
• Lunt M, Watson KD, Dixon WG et al. No evidence of association between anti-tumor necrosis factor treatment and mortality in patients with rheumatoid arthritis: results from the british society for rheumatology biologics register. Arthritis Rheum.62, 3145–3153 (2010).
   PubMed Web of Science ®Google Scholar
• Atzeni F, Turiel M, Capsoni F, Doria A, Meroni P, Sarzi-Puttini P. Autoimmunity and anti-TNF-alpha agents. Ann. NY Acad. Sci.1051, 559–569 (2005).
   PubMed Web of Science ®Google Scholar
• Atzeni F, Sarzi-Puttini P. Autoantibody production in patients treated with anti-TNF-alpha. Expert Rev. Clin. Immunol.4, 275–280 (2008).
   PubMed Web of Science ®Google Scholar
• Saint Marcoux B, De Bandt M; CRI (Club Rhumatismes et Inflammation). Vasculitides induced by TNFalpha antagonists: a study in 39 patients in France. Joint Bone Spine73, 710–713 (2006).
   PubMed Web of Science ®Google Scholar
• Abourazzak FE, Guggenbuhl P, Perdriger A et al. Cutaneous lupus induced by etanercept in rheumatoid arthritis. Rev. Med. Interne.29, 744–747 (2008).
   PubMedGoogle Scholar
• Murashima A, Watanabe N, Ozawa N, Saito H, Yamaguchi K. Etanercept during pregnancy and lactation in a patient with rheumatoid arthritis: drug levels in maternal serum, cord blood, breast milk and the infant’s serum. Ann. Rheum. Dis.68(11), 1793–1794 (2009).
   PubMed Web of Science ®Google Scholar
• Verstappen SM, King Y, Watson KD, Symmons DP, Hyrich KL; BSRBR Control Centre Consortium, BSR Biologics Register. Anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register. Ann. Rheum. Dis.70(5), 823–826 (2011).
   PubMed Web of Science ®Google Scholar
• Hazes JM, Coulie PG, Geenen V et al. Rheumatoid arthritis and pregnancy: evolution of disease activity and pathophysiological considerations for drug use. Rheumatology50(11), 1955–1968 (2011).
   PubMed Web of Science ®Google Scholar
• Arnett FC, Edworthy SM, Bloch DA et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum.31, 315–324 (1988).
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewé R, Breedveld FC et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann. Rheum. Dis.69(6), 964–975 (2010).
   PubMed Web of Science ®Google Scholar
• Alonso-Ruiz A, Pijoan JI, Ansuategui E, Urkaregi A, Calabozo M, Quintana A. Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and meta-analysis of efficacy and safety. BMC Musculoskelet. Disord.9, 52 (2008).
   PubMed Web of Science ®Google Scholar
• Singh JA, Wells GA, Christensen R et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst. Rev.16(2), CD008794 (2011).
   Google Scholar
• Weinblatt M, Bathon J, Kremer JM et al. Safety and efficacy of etanercept beyond 10 years therapy in North American patients with early and long-standing rheumatoid arthritis. Arthritis Care Res.63, 373–382 (2011).
   PubMedGoogle Scholar
• Atzeni F, Sarzi-Puttini P, Gorla R, Marchesoni A, Caporali R. Switching rheumatoid arthritis treatments: an update. Autoimmun. Rev.10(7), 397–403 (2011).
   PubMed Web of Science ®Google Scholar
• Soini E, Hallinen T, Puolakka K, Vihervaara V, Kauppi M. Cost–effectiveness of adalimumab, etanercept and tocilizumab as first-line treatments for moderate-to-severe rheumatoid arthritis. J. Med. Econ. doi:10.3111/13696998.2011.649327 (2011) (Epub ahead of print).
   Google Scholar
• Gu N, Yi S, Kim TE et al. Comparative Pharmacokinetics and Tolerability of Branded Etanercept (25 mg) and Its Biosimilar (25 mg): a randomized, open-label, single-dose, two-sequence, crossover study in healthy Korean male volunteers. Clin. Ther.33(12), 2029–2037 (2011).
   PubMed Web of Science ®Google Scholar