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  • 1
    Bulpitt KJ. Biologic therapies in rheumatoid arthritis. Curr Rheumatol Rep 1999; 1: 15763.
  • 2
    Emery P, Durez P, Dougados M, Legerton CW, Becker JC, Vratsanos G, et al. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis 2010; 69: 5106.
  • 3
    Westhovens R, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, et al. Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors. Ann Rheum Dis 2009; 68: 18707.
  • 4
    Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition. N Engl J Med 2005; 353: 111423.
  • 5
    Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, et al. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis 2008; 67: 54754.
  • 6
    Kremer JM, Dougados M, Emery P, Durez P, Sibilia J, Shergy W, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005; 52: 226371.
  • 7
    Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 2006; 144: 86576.
  • 8
    Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, et al. Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum 2008; 58: 95363.
  • 9
    Westhovens R, Kremer JM, Moreland LW, Emery P, Russell AS, Li T, et al. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol 2009; 36: 73642.
  • 10
    Orencia (abatacept) prescribing information. Princeton (NJ): Bristol-Myers Squibb; 2009. URL: http://packageinserts.bms.com/pi/pi_orencia.pdf.
  • 11
    Corbo M, Valencia X, Raymond R, Summerill R, Agrawal S, Shergy W, et al. A subcutaneous administration regimen for abatacept in patients with rheumatoid arthritis: pharmacokinetics, safety and immunogenicity [abstract]. Arthritis Rheum 2008; 58 Suppl: S307.
  • 12
    Corbo M, Valencia X, Raymond R, Summerill R, Agrawal S, Townsend R, et al. Subcutaneous administration of abatacept in patients with rheumatoid arthritis: pharmacokinetics, safety and immunogenicity [abstract]. Ann Rheum Dis 2009; 68 Suppl III: iii574.
  • 13
    Nash P, Nayiager S, Genovese M, Kivitz A, Oelke K, Ludivico C, et al. Immunogenicity is not increased with subcutaneous administration of abatacept with and without methotrexate in patients with rheumatoid arthritis: results from a phase III study [abstract]. Arthritis Rheum 2009; 60 Suppl: S6334.
  • 14
    Nash P, Nayiager S, Genovese MC, Rodriguez C, Delaet I, Elegbe A, et al. Low immunogenicity, consistent safety and sustained clinical efficacy over 18 months of subcutaneous administration of abatacept with and without methotrexate in patients with rheumatoid arthritis—results from a phase III study [abstract]. Ann Rheum Dis 2010; 69 Suppl III: iii97. Oral OP0132.
  • 15
    Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 31524.
  • 16
    Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992; 35: 498502.
  • 17
    Methotrexate-inadequate response study. 2011. URL: http://clinicaltrials.gov/ct2/show/NCT00559585?term=abatacept&phase=2&rank=18.
  • 18
    A population pharmacokinetic and pharmacodynamic analysis for abatacept: relationship between abatacept concentrations and ACR 20 and DAS28 response. Document Control No. 930012830. Data on file. Princeton (NJ): Bristol-Myers Squibb. 2006.
  • 19
    Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995; 38: 72735.
  • 20
    Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980; 23: 13745.
  • 21
    Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight–joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995; 38: 448.
  • 22
    Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol 1993; 20: 55760.
  • 23
    Kremer JM, Westhovens R, Leon M, Di Giorgio E, Alten R, Steinfeld S, et al. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 2003; 349: 190715.
  • 24
    Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 2008; 67: 1096103.
  • 25
    European Medicines Agency. Guideline on choice of the non-inferiority margin. 2005. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003636.pdf.
  • 26
    European Medicines Agency. ICH Topic E9. Statistical principles for clinical trials. 1998. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf.
  • 27
    European Medicines Agency. ICH Topic E10. Choice of control group. 2000. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf.
  • 28
    D'Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med 2003; 22: 16986.
  • 29
    Human mixed lymphocyte reaction proliferation and cytokine production. BMS-188667. Document Control No. 930007790. Data on file. Princeton (NJ): Bristol-Myers Squibb; 2004.
  • 30
    Hochberg M, Westhovens R, Aranda R, Kelly SM, Khan N, Qi K, et al. Long-term safety of abatacept: integrated analysis of clinical program data of up to 7 years of treatment [abstract]. Arthritis Rheum 2010; 62 Suppl: S1645.
  • 31
    Humira (adalimumab) prescribing information. North Chicago (IL): Abbott; 2011. URL: http://www.rxabbott.com/pdf/humira.pdf.
  • 32
    Frenken LA, van Lier HJ, Gerlag PG, den Hartog M, Koene RA. Assessment of pain after subcutaneous injection of erythropoietin in patients receiving haemodialysis. BMJ 1991; 303: 288.
  • 33
    Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al. 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 2004; 363: 67581.
  • 34
    Van Riel PL, Taggart AJ, Sany J, Gaubitz M, Nab HW, Pedersen R, et al. 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 2006; 65: 147883.
  • 35
    Enbrel prescribing information. Thousand Oaks (CA): Amgen; 2011. URL: http://www.enbrel.com/documents/ENBREL-Prescribing-Information.pdf.
  • 36
    Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, et al. Adalimumab, a fully human anti tumor necrosis factor-α 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 2003; 30: 256371.
  • 37
    Radstake TR, Svenson M, Eijsbouts AM, van den Hoogen FH, Enevold C, van Riel PL, et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2009; 68: 173945.
  • 38
    Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al. Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 2010; 69: 81721.
  • 39
    Haggerty HG, Abbott MA, Reilly TP, DeVona DA, Gleason CR, Tay L, et al. Evaluation of immunogenicity of the T cell costimulation modulator abatacept in patients treated for rheumatoid arthritis. J Rheumatol 2007; 34: 236573.