Efficacy and safety of additional use of tacrolimus in patients with early rheumatoid arthritis with inadequate response to DMARDs—a multicenter, double-blind, parallel-group trial

References

• Panayi GS, Lanchbury JS, Kingsley GH. The importance of the T cell in initiating and maintaining the chronic synovitis of rheu-matoid arthritis. Arthritis Rheum. 1992;35(7):729–35.
   PubMed Web of Science ®Google Scholar
• Sakuma S, Kato Y, Nishigaki F, Sasakawa T, Magari K, Miyata S, et al. FK506 potently inhibits T cell activation induced TNF-alpha and IL- lbeta production in vitro by human peripheral blood mononuclear cells. Br J Pharmacol. 2000;130(7):1655–63.
   PubMed Web of Science ®Google Scholar
• Sakuma S, Kato Y, Nishigaki F, Magari K, Miyata S, Ohkubo Y, et al. Effects of FK506 and other immunosuppressive anti-rheu-matic agents on T cell activation mediated IL-6 and IgM pro-duction in vitro. Int Immunopharmacol. 2001;1(4):749–57.
   PubMed Web of Science ®Google Scholar
• Kino T, Hatanaka H, Miyata S, Inamura N, Nishiyama M, Yajima T, et al. FK-506, a novel immunosuppressant isolated from a Streptomyces II. Immunosuppressive effect of FK-506 in vitro. J Antibiot (Tokyo). 1987;40(9):1256–65.
   Google Scholar
• Miyahara H, Hotokebuchi T, Arita C, Arai K, Sugioka Y, Takagishi K, et al. Comparative studies of the effects of FK506 and cyclosporin A on passively transferred collagen-induced arthritis in rats. Clin Immunol Immunopathol. 1991;60(2):278–88.
   PubMedGoogle Scholar
• Sakuma S, Nishigaki F, Magari K, Ogawa T, Miyata S, Ohkubo Y, et al. FK506 is superior to methotrexate in therapeutic effects on advanced stage of rat adjuvant-induced arthritis. Inflamm Res. 2001 ;50(10) :509–14.
   PubMed Web of Science ®Google Scholar
• Kondo H, Abe T, Hashimoto H, Uchida S, Irimajiri S, Hara M, et al. Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo con-trolled dose-finding study. J Rheumatol. 2004;31(2):243–51.
   PubMed Web of Science ®Google Scholar
• Kawai S, Hashimoto H, Kondo H, Murayama T, Kiuchi T, Abe T. Comparison of tacrolimus and mizoribine in a randomized, double-blind controlled study in patients with rheumatoid arthritis. J Rheumatol. 2006;33(11):2153–61. Epub 2006 Sep 1.
   Google Scholar
• Kremer JM, Habros JS, Kolba KS, Kaine JL, Borton MA, Mengle-Gaw LJ, et al. Tacrolimus in rheumatoid arthritis patients receiving concomitant methotrexate: a six-month, open-label study. Arthritis Rheum. 2003;48(10):2763–8.
   Google Scholar
• Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying anti-rheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008; 59(6):762–84.
   PubMed Web of Science ®Google Scholar
• Fuchs HA, Kaye JJ, Callahan LF, Nance EP, Pincus T. Evidence of significant radiographic damage in rheumatoid arthritis within the first 2 years of disease. J Rheumatol. 1989;16(5):585–91.
   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
• 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
• 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(1):44–8.
   Google Scholar
• van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthri-tis. Comparison with the preliminary American College of Rheuma-tology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum. 1996;39(1):34–40.
   Google Scholar
• Fransen J, Creemers MC, Van Riel PL. Remission in rheumatoid arthritis: agreement of the disease activity score (DA528) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004;43(10) : 1252–5.
   Google Scholar
• Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983;26(11):1346–53.
   Google Scholar
• van der Heijde DM. Plain X-rays in rheumatoid arthritis: over-view of scoring methods, their reliability and applicability. Baillieres Clin Rheumatol. 1996;10(3):435–53.
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Simon L, Smolen J, Strand V, Sharp J, Boers M, et al. How to report radiographic data in randomized clinical trials in rheumatoid arthritis: guidelines from a roundtable dis-cussion. Arthritis Rheum. 2002;47(2):215–8.
   PubMed Web of Science ®Google Scholar
• Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al. Therapeutic effect of the combination of eta-nercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet. 2004;363(9410):675–81.
   PubMed Web of Science ®Google Scholar
• Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48(1):35–45.
   PubMed Web of Science ®Google Scholar
• Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial ATTRACT Study Group. Lancet. 1999;354(9194): 1932–9.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Aletaha D, Koeller M, Weisman MH, Emery P. New therapies for treatment of rheumatoid arthritis. Lancet. 2007; 370(9602) : 1861–74.
   Google Scholar
• Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Kerstens PJ, Nielen MM, Vos K, van Schaardenburg D, et al. DAS-driven therapy versus routine care in patients with recent-onset active rheumatoid arthritis. Ann Rheum Dis. 2010;69(1):65–9.
   Google Scholar
• Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, et al. Treating rheumatoid arthritis to target: rec-ommendations of an international task force. Ann Rheum Dis. 2010;69(4):631–7.
   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(9):1162–7.
   PubMed Web of Science ®Google Scholar
• St Clair EW, van der Heijde DM, Smolen JS, Maim RN, Bathon JM, Emery P, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004;50(10:3432–43.
   PubMed Web of Science ®Google Scholar
• Sharp JT, Strand V, Leung H, Hurley F, Loew-Friedrich I. Treatment with leflunomide slows radiographic progression of rheumatoid arthritis: results from three randomized controlled trials of leflunomide in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum. 2000;43(3):495–505.
   Google Scholar
• Kerstens PJ, Boerbooms AM, Jeurissen ME, de Graaf R, Mulder J, van de Putte LB. Radiological and clinical results of longterm treatment of rheumatoid arthritis with methotrexate and azathio-prine. J Rheumatol. 2000;27(5):1148–55.
   Google Scholar
• van der Heijde DM, van Riel PL, Nuver-Zwart IH, Gribnau FW, van de Putte LB. Effects of hydoxychloroquine and sulphasal-azine on progression of joint damage in rheumatoid arthritis. Lancet. 1989;1(8646):1036–8.
   PubMed Web of Science ®Google Scholar
• Akimoto K, Kusunoki Y, Nishio S, Takagi K, Kawai S. Safety profile of tacrolimus in patients with rheumatoid arthritis. Clin Rheumatol. 2008;27(11):1393–7.
   Google Scholar
• Kawai S, Tanaka K, Ohno I, Utsunomiya K, Seino Y. Safety of long-term tacrolimus therapy for rheumatoid arthritis: an open-label, uncontrolled study in non-elderly patients. Mod Rheuma-tol. 2008;18(4):345–53.
   Google Scholar
• Furst DE, Saag K, Fleischmann MR, Sherrer Y, Block JA, Schnitzer T, et al. Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with methotrexate: a six-month, double-blind, randomized, dose-ranging study. Arthritis Rheum. 2002;46(8):2020–8.
   PubMed Web of Science ®Google Scholar
• Yocum DE, Furst DE, Bensen WG, Burch FX, Borton MA, Mengle-Gaw LJ, et al. Safety of tacrolimus in patients with rheu-matoid arthritis: long-term experience. Rheumatology (Oxford). 2004;43(8):992–9.
   Google Scholar
• Yocum DE, Furst DE, Kaine JL, Baldassare AR, Stevenson JT, Borton MA, Tacrolimus Rheumatoid Arthritis Study Group, et al. Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial. Arthritis Rheum. 2003;48(12): 3328–37.
   PubMed Web of Science ®Google Scholar
• Morgan SL, Baggott JE, Vaughn WH, Young PK, Austin JV, Krumdieck CL, et al. The effect of folic acid supplementation on the toxicity of low-dose methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 1990;33(1):9–18.
   PubMed Web of Science ®Google Scholar
• Shiroky JB, Neville C, Esdaile JM, Choquette D, Zummer M, Hazeltine M, et al. Low-dose methotrexate with leucovorin (folinic acid) in the management of rheumatoid arthritis. Results of a multicenter randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 1993;36(6):795–803.
   PubMed Web of Science ®Google Scholar