Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs

References

• Saeki Y, Matsui T, Saisho K, Tohma S. Current treatments of rheumatoid arthritis: from the ‘NinJa’ registry. Expert Rev Clin Immunol. 2012;8(5):455–65.
   PubMed Web of Science ®Google Scholar
• Salliot C, van der Heijde D. Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research. Ann Rheum Dis. 2009;68(7):1100–4.
   PubMed Web of Science ®Google Scholar
• Visser K, van der Heijde D. Optimal dosage and route of administration of methotrexate in rheumatoid arthritis: a systematic review of the literature. Ann Rheum Dis. 2009;68(7):1094–9.
   Google Scholar
• Wells AF, Westhovens R, Reed DM, Fanti L, Becker JC, Covucci A, Keystone EC. Abatacept plus methotrexate provides incremental clinical benefits versus methotrexate alone in methotrexate-naive patients with early rheumatoid arthritis who achieve radiographic nonprogression. J Rheumatol. 2011;38(11):2362–8.
   Google Scholar
• Weaver AL, Lautzenheiser RL, Schiff MH, Gibofsky A, Perruquet JL, Luetkemeyer J, et al. Real-world effectiveness of select biologic and DMARD monotherapy and combination therapy in the treatment of rheumatoid arthritis: results from the RADIUS observational registry. Curr Med Res Opin. 2006;22(1):185–98.
   Google Scholar
• Bulpitt KJ. Biologic therapies in rheumatoid arthritis. Curr Rheumatol Rep. 1999;1(2):157–63.
   Google Scholar
• Moreland LW, Alten R, Van den Bosch F, Appelboom T, Leon M, Emery P, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double-blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum. 2002;46(6):1470–9.
   PubMed Web of Science ®Google Scholar
• Bathon J, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, et al. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes. Ann Rheum Dis. 2011;70(11):1949–56.
   PubMedGoogle Scholar
• Kremer JM, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Westhovens R, et al. Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Ann Rheum Dis. 2011;70(10): 1826–30.
   PubMedGoogle Scholar
• 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(8):1096–103.
   PubMed Web of Science ®Google Scholar
• 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(4):547–54.
   PubMed Web of Science ®Google Scholar
• Takeuchi T, Matsubara T, Nitobe T, Suematsu E, Ohta S, Honjo S, et al. Phase II dose-response study of abatacept in Japanese patients with active rheumatoid arthritis with an inadequate response to methotrexate. Mod Rheumatol. 2013;23(2):226–35.
   PubMed Web of Science ®Google Scholar
• Matsubara T, Yamana S, Tohma S, Takeuchi T, Kondo H, Kohsaka H, et al. Tolerability and efficacy of abatacept in Japanese patients with rheumatoid arthritis: a phase I study. Mod Rheumatol. 2012; Epub ahead of print: doi: 10.1007/s10165-012-0722-x.
   Google Scholar
• Ma Y, Lin BR, Lin B, Hou S, Qian WZ, Li J, et al. Pharmacokinetics of CTLA4Ig fusion protein in healthy volunteers and patients with rheumatoid arthritis. Acta Pharmacol Sin. 2009;30(3):364–71.
   Google Scholar
• 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(3):315–24.
   PubMed Web of Science ®Google Scholar
• 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(5):498–502.
   PubMedGoogle Scholar
• 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(6):727–35.
   PubMed Web of Science ®Google Scholar
• Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23(2):137–45.
   PubMed Web of Science ®Google Scholar
• 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(4):736–42.
   PubMedGoogle Scholar
• Genovese MC, Schiff M, Luggen M, Le Bars M, Aranda R, Elegbe A, Dougados M. Longterm safety and efficacy of abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy. J Rheumatol. 2012;39(8):1546–54.
   Google Scholar
• Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, et al. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009;68(7):1220–7.
   Google Scholar
• Weisman MH, Durez P, Hallegua D, Aranda R, Becker JC, Nuamah I, et al. Reduction of inflammatory biomarker response by abatacept in treatment of rheumatoid arthritis. J Rheumatol. 2006;33(11):2162–6.
   Google Scholar
• 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(3):510–6.
   Google Scholar
• Buch MH, Aletaha D, Emery P, Smolen J. Reporting of long-term extension studies: lack of consistency calls for consensus. Ann Rheum Dis. 2011;70(6):886–90.
   Google Scholar