Assessment of the validity of the 28-joint disease activity score using erythrocyte sedimentation rate (DAS28-ESR) as a disease activity index of rheumatoid arthritis in the efficacy evaluation of 24-week treatment with tocilizumab: subanalysis of the SATORI study

References

• Mihara M, Kasutani K, Okazaki M, Nakamura A, Kawai S, Sugimoto M, et al. Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family. Int Immunopharmacol. 2005;5 :1731–40.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Yoshizaki K, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, et al. Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 2004;50: 1761–9.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007;66:1162–7.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J, et al. Study of active controlled tocilizumab mono-therapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19:12–9.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis. 2009;68:1580–4.
   PubMed Web of Science ®Google Scholar
• Yokota S, Miyamae T, Imagawa T, Iwata N, Katakura S, Mori M, et al. Therapeutic efficacy of humanized recombinant anti-inter-leukin-6 receptor antibody in children with systemic-onset juve-nile idiopathic arthritis. Arthritis Rheum. 2005;52:818–25.
   PubMed Web of Science ®Google Scholar
• Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008;371: 998–1006.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Kanakura Y, Aozasa K, Johkoh T, Nakamura M, Nakano S, et al. Humanized anti-interleukin-6 receptor antibody treatment of multicentric Castleman disease. Blood. 2005;106: 2627–32.
   PubMed Web of Science ®Google Scholar
• Mima T, Nishimoto N. Clinical value of blocking IL-6 receptor. Curr Opin Rheumatol. 2009;21:224–30.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, OPTION investigators, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371: 987–97.
   Google Scholar
• Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, et al. Interleukin-6 receptor inhibition with toc-ilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modify-ing antirheumatic drug therapy study. Arthritis Rheum. 2008; 58:2968–80.
   PubMed Web of Science ®Google Scholar
• Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-con-trolled trial. Ann Rheum Dis. 2008;67:1516–23.
   PubMed Web of Science ®Google Scholar
• Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, et al. Com-parison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010;69:88–96.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Yoshizaki K, Maeda K, Kuritani T, Deguchi H, et al. Toxicity, pharmacokinetics, and dose-finding study of repetitive treatment with the humanized anti-interleukin 6 receptor antibody MRA in rheumatoid arthritis. Phase I/II clinical study. J Rheumatol. 2003;30:1426–35.
   Google Scholar
• 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;38:44–8.
   Google Scholar
• Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther. 2005;7:R796–806.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford). 2003;42:244–57.
   PubMed Web of Science ®Google Scholar
• Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Pre-liminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727–35.
   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;35:498–502.
   PubMed Web of Science ®Google Scholar
• van Gestel AM, Anderson JJ, van Riel PL, Boers M, Haagsma CJ, Rich B, et al. ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology. J Rheumatol. 1999;26:705–11.
   PubMed Web of Science ®Google Scholar
• Fransen J, Creemers MC, Van Riel PL. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004;43: 1252–5.
   Google Scholar
• Aletaha D, Funovits J, Keystone EC, Smolen JS. Disease activity early in the course of treatment predicts response to therapy after one year in rheumatoid arthritis patients. Arthritis Rheum. 2007;56:3226–35.
   PubMed Web of Science ®Google Scholar
• Aletaha D, Smolen JS. The simplified disease activity index (SDAI) and clinical disease activity index (CDAI) to monitor patients in standard clinical care. Best Pract Res Clin Rheumatol. 2007;21:663–75.
   PubMed Web of Science ®Google Scholar
• Shaver TS, Anderson JD, Weidensaul DN, Shahouri SS, Busch RE, et al. The problem of rheumatoid arthritis disease activity and remission in clinical practice. J Rheumatol. 2008;35:1015–22.
   PubMed Web of Science ®Google Scholar
• Sokka T, Hetland ML, Mäkinen H, Kautiainen H, Horsley-Pet-ersen K, Luukkainen RK, Questionnaires in Standard Monitoring of Patients With Rheumatoid Arthritis Group, et al. Remission and rheumatoid arthritis: data on patients receiving usual care in twenty-four countries. Arthritis Rheum. 2008;58:2642–51.
   Google Scholar
• Mäkinen H, Kautiainen H, Hannonen P, Sokka T. Is DA528 an appropriate tool to assess remission in rheumatoid arthritis? Ann Rheum Dis. 2005;64: 1410–3.
   Google Scholar