Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: An open-label extension of a randomized, double-blind, placebo-controlled trial

References

• Kawakami A, Tsuboi M, Urayama S, Matsuoka N, Yamasaki S, Hida A, et al. Inhibitory effect of a new anti-rheumatic drug T-614 on costimulatory molecule expression, cytokine production, and antigen presentation by synovial cells. J Lab Clin Med. 1999; 133(6):566–74.
   PubMed Web of Science ®Google Scholar
• Kohno M, Aikawa Y, Tsubouchi Y, Hashiramoto A, Yamada R, Kawahito Y, et al. Inhibitory effect of T-614 on tumor necrosis factor-alpha induced cytokine production and nuclear factor-kappaB activation in cultured human synovial cells. J Rheumatol. 2001;28(12):2591–6.
   PubMed Web of Science ®Google Scholar
• Aikawa Y, Yamamoto M, Yamamoto T, Morimoto K, Tanaka K. An anti-rheumatic agent T-614 inhibits NF-kappaB activation in LPS- and TNF-alpha-stimulated THP-1 cells without interfering with IkappaBalpha degradation. Inflamm Res. 2002;51(4):188–94.
   PubMed Web of Science ®Google Scholar
• Tanaka K, Yamamoto T, Aikawa Y, Kizawa K, Muramoto K, Matsuno H, et al. Inhibitory effects of an anti-rheumatic agent T-614 on immunoglobulin production by cultured B cells and rheumatoid synovial tissues engrafted into SCID mice. Rheumatology 2003; 42(11):1365–71.
   PubMed Web of Science ®Google Scholar
• Hara M, Abe T, Sugawara S, Mizushima Y, Hoshi K, Irimajiri S, et al. Efficacy and safety of iguratimod compared with placebo and salazosulfapyridine in active rheumatoid arthritis: a controlled, multicenter, double-blind, parallel-group study. Mod Rheumatol. 2007;17(1):1–9.
   PubMedGoogle Scholar
• Tian H, Cronstein BN. Understanding the mechanisms of action of methotrexate: implications for the treatment of rheumatoid arthritis. Bull NYU Hosp Jt Dis. 2007;65(3):168–73.
   PubMedGoogle Scholar
• Chan ES, Cronstein BN. Methotrexate–how does it really work?Nat Rev Rheumatol. 2010;6(3):175–8.
   PubMed Web of Science ®Google Scholar
• Akkari R, Burbiel JC, Hockemeyer J, Müller CE. Recent progress in the development of adenosine receptor ligands as antiinflammatory drugs. Curr Top Med Chem. 2006;6(13):1375–99.
   PubMed Web of Science ®Google Scholar
• Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625–39.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewé R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010; 69(6):964–75.
   PubMed Web of Science ®Google Scholar
• Ishiguro N, Yamamoto K, Katayama K, Kondo M, Sumida T, Minori T, et al. Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate: a randomized, double-blind, placebo-controlled trial. Mod Rheumatol. 2013;23(3):430–9.
   PubMed Web of Science ®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
• 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.
   PubMed Web of Science ®Google Scholar
• Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol. 1982;9(5):789–93.
   PubMed Web of Science ®Google Scholar
• Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware JE Jr. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. 2000;43(7):1478–87.
   PubMed Web of Science ®Google Scholar
• Fransen J, van Riel PL. Outcome measures in inflammatory rheumatic diseases. Arthritis Res Ther. 2009;11(5):244.
   PubMed Web of Science ®Google Scholar
• Kawai S, Takeuchi T, Yamamoto K, Tanaka Y, Miyasaka N. 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. Mod Rheumatol. 2011;21(5):458–68.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, et al. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis. 2012;71(6):817–24.
   PubMed Web of Science ®Google Scholar
• Hara M, Abe T, Sugawara S, Mizushima Y, Hoshi K, Irimajiri S, et al. Long-term safety study of iguratimod in patients with rheumatoid arthritis. Mod Rheumatol. 2007;17(1):10–6.
   PubMedGoogle Scholar
• Rheumatoid Arthritis Clinical Trial Archive Group. The effect of age and renal function on the efficacy and toxicity of methotrexate in rheumatoid arthritis. J Rheumatol. 1995;22(2):218–23.
   PubMed Web of Science ®Google Scholar
• Borchers AT, Keen CL, Cheema GS, Gershwin ME. The use of methotrexate in rheumatoid arthritis. Semin Arthritis Rheum. 2004;34(1):465–83.
   PubMed Web of Science ®Google Scholar
• Tak PP, Kalden JR. Advances in rheumatology: new targeted therapeutics. Arthritis Res Ther. 2011;13 Suppl 1:S5.
   Web of Science ®Google Scholar
• American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 Update. Arthritis Rheum. 2002;46(2):328–46.
   PubMedGoogle Scholar