A multicenter, open-label, efficacy, pharmacokinetic, and safety study of adalimumab in Japanese patients with ankylosing spondylitis

References

• Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, et al. The development of Assessment of Spondylo-Arthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68:777–83.
   PubMed Web of Science ®Google Scholar
• Braun J, Bollow M, Remlinger G, Eggens U, Rudwaleit M, Distler A, et al. Prevalence of spondylarthropathies in HLA-B27 positive and negative blood donors. Arthritis Rheum. 1998;41: 58–67.
   PubMed Web of Science ®Google Scholar
• Hukuda S, Minami M, Saito T, Mitsui H, Matsui N, Komatsubara Y, et al. Spondyloarthropathies in Japan: nationwide question-naire survey performed by the Japan Ankylosing Spondylitis Society. J Rheumatol. 2001;28:554–9.
   PubMed Web of Science ®Google Scholar
• Yamaguchi A, Tsuchiya N, Mitsui H, Shiota M, Ogawa A, Toku-naga K, et al. Association of HLA-B39 with HLA-B27-negative ankylosing spondylitis and pauciarticular juvenile rheumatoid arthritis in Japanese patients. Evidence for a role of the peptide-anchoring B pocket. Arthritis Rheum. 1995;38: 1672–7.
   Google Scholar
• Rudwaleit M, Khan MA, Sieper J. The challenge of diagnosis and classification in early ankylosing spondylitis: do we need new criteria? Arthritis Rheum. 2005;52:1000–8.
   Google Scholar
• Boonen A, van der Heijde D, Landewe R, Spoorenberg A, Schouten H, Rutten-van Molken M, et al. Work status and pro-ductivity costs due to ankylosing spondylitis: comparison of three European countries. Ann Rheum Dis. 2002;61:429–37.
   Google Scholar
• Ward MM. Functional disability predicts total costs in patients with ankylosing spondylitis. Arthritis Rheum. 2002;46:223–31.
   PubMedGoogle Scholar
• Boonen A, van der Heijde D, Landewe R, Guillemin F, Rutten-van Molken M, Dougados M, et al. Direct costs of ankylosing spondylitis and its determinants: an analysis among three Euro-pean countries. Ann Rheum Dis. 2003;62:732–40.
   Google Scholar
• Braun J, van den Berg R, Baraliakos X, Boehm H, Burgos-Vargas R, Collantes-Estevez E, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70: 896–904.
   Web of Science ®Google Scholar
• Ward MM, Kuzis S. Medication toxicity among patients with ankylosing spondylitis. Arthritis Rheum. 2002;47:234–41.
   PubMedGoogle Scholar
• Braun J, Bollow M, Neure L, Seipelt E, Seyrekbasan F, Herbst H, et al. Use of immunohistologic and in situ hybridization tech-niques in the examination of sacroiliac joint biopsy specimens from patients with ankylosing spondylitis. Arthritis Rheum. 1995;38:499–505.
   PubMed Web of Science ®Google Scholar
• Braun J, Brandt J, Listing J, Zink A, Alten R, Golder W, et al. Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet. 2002;359:1187–93.
   PubMed Web of Science ®Google Scholar
• Gorman JD, Sack KE, Davis JC Jr. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med. 2002;346:1349–56.
   Google Scholar
• Van Den Bosch F, Kruithof E, Baeten D, Herssens A, de Keyser F, Mielants H, et al. Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) versus placebo in active spondylarthropathy. Arthritis Rheum. 2002;46:755–65.
   PubMed Web of Science ®Google Scholar
• Davis JC Jr, Van Der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a ran-domized, controlled trial. Arthritis Rheum. 2003;48:3230–6.
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Dijkmans B, Geusens P, Sieper J, DeWoody K, Williamson P, et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum. 2005;52:582–91.
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Kivitz A, Schiff MH, Sieper J, Dijkmans BA, Braun J, et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006;54: 2136–46.
   PubMed Web of Science ®Google Scholar
• Lambert RG, Salonen D, Rahman P, Inman RD, Wong RL, Einstein SG, et al. Adalimumab significantly reduces both spinal and sacroiliac joint inflammation in patients with ankylosing spondylitis: a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2007;56:4005–14.
   PubMed Web of Science ®Google Scholar
• Inman RD, Davis JC Jr, Heijde D, Diekman L, Sieper J, Kim SI, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-con-trolled, phase III trial. Arthritis Rheum. 2008;58:3402–12.
   PubMed Web of Science ®Google Scholar
• van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984;27:361–8.
   PubMed Web of Science ®Google Scholar
• Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary defini-tion of short-term improvement in ankylosing spondylitis. Arthritis Rheum. 2001;44:1876–86.
   Google Scholar
• Weisman MH, Moreland LW, Furst DE, Weinblatt ME, Keystone EC, Paulus HE, et al. Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study. Clin 'Ther. 2003;25:1700–21.
   PubMed Web of Science ®Google Scholar
• Pavy S, Brophy S, Calin A. Establishment of the minimum clinically important difference for the bath ankylosing spondylitis indices: a prospective study. J Rheumatol. 2005;32:80–5.
   Google Scholar
• Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics. 1999;15:141–55.
   PubMed Web of Science ®Google Scholar
• Humira [package insert]. In: Abbott; 2011.
   Google Scholar
• Burmester GR, Mease P, Dijkmans BA, Gordon K, Lovell D, Panaccione R, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory dis-eases. Ann Rheum Dis. 2009;68:1863–9.
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Pangan AL, Schiff MH, Braun J, Borofsky M, Tone J, et al. Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis. Ann Rheum Dis. 2008;67:1218–21.
   PubMed Web of Science ®Google Scholar
• Miyasaka N. Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Mod Rheumatol. 2008;18:252–62.
   PubMed Web of Science ®Google Scholar
• Asahina A, Nakagawa H, Etoh T, Ohtsuki M. Adalimumab in Japanese patients with moderate to severe chronic plaque psori-asis: efficacy and safety results from a phase II/III randomized controlled study. J Dermatol. 2010;37:299–310.
   PubMed Web of Science ®Google Scholar
• Schiff MH, Burmester GR, Kent JD, Pangan AL, Kupper H, Fitzpatrick SB, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis. 2006;65:889–94.
   PubMed Web of Science ®Google Scholar