Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis

REFERENCES

• Breedveld FC, Dayer JM. Leflunomide: mode of action in the treatment of rheumatoid arthritis. Ann Rheum Dis. 2000;59: 841–9.
   PubMed Web of Science ®Google Scholar
• Weyand CM. New insights into the pathogenesis of rheumatoid arthritis. Rheumatology. 2000;39(Suppl 1):3–8.
   PubMed Web of Science ®Google Scholar
• Arend WP, Dayer JM. Inhibition of the production and effects of interleukin-1 and tumor necrosis factor alpha in rheumatoid arthritis. Arthritis Rheum. 1995;38:151–60.
   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: 1256–65.
   Google Scholar
• Sakuma S, Kato Y, Nishigaki F, Sasakawa T, Magari K, Miyata S, et al. FK506 potently inhibits T cell activation induced TNF-a and IL-lb production in vitro by human peripheral blood mononuclear cells. Br J Pharmacol. 2000;130:1655–63.
   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;1:749–57.
   PubMed Web of Science ®Google Scholar
• Magari K, Miyata S, Nishigaki F, Ohkubo Y, Mutoh S. Com-parison of anti-arthritic properties of leflunomide with metho-trexate and FK506: effect on T cell activation-induced inflammatory cytokine production in vitro and rat adjuvant-induced arthritis. Inflamm Res. 2004;53: 544–50.
   Google Scholar
• Kondo H, Abe T, Hashimoto H, Uchida S, Irimajiri S, Hara M, et al. Efficacy and safety of TAC (FK506) in treatment of rheumatoid arthritis: a randomized, double-blind, placebo-con-trolled dose-finding study. J Rheumatol. 2004;31:243–51.
   PubMed Web of Science ®Google Scholar
• Yocum DE, Furst DE, Kaine JL, Baldassare AR, Stevenson JT, Borton MA, et al. Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial. Arthritis Rheum. 2003;48:3328–37.
   PubMed Web of Science ®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;46:2020–8.
   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;33:2153–61.
   PubMed Web of Science ®Google Scholar
• Kawai S, Yamamoto K. Safety of tacrolimus, an immunosup-pressive agent, in the treatment of rheumatoid arthritis in elderly patients. Rheumatology (Oxford). 2006;45:441–4.
   PubMed Web of Science ®Google Scholar
• Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189–94.
   PubMed Web of Science ®Google Scholar
• Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009;36:898–906.
   PubMed Web of Science ®Google Scholar
• Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients. Ann Rheum Dis. 2011;70:2148–51.
   PubMed Web of Science ®Google Scholar
• Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheu-matoid arthritis patients: postmarketing surveillance report of the first 3,000 patients. Mod Rheumatol. 2012;22:498–508.
   PubMed Web of Science ®Google Scholar
• Ochiai T, Fukao K, Takahashi K, Endo T, Oshima S, Uchida K, et al. Phase III study of FK 506 in kidney transplantation. Japa-nese FK 506 Study Group. Transplant Proc. 1995;27:829–33.
   PubMedGoogle Scholar
• Ochiai T, Ishibashi M, Fukao K, et al. Japanese multicenter studies of FK 506 in renal transplantation. Japanese FK 506 Study Group. Transplant Proc. 1995;27:50–3.
   PubMed Web of Science ®Google Scholar
• Japanese FK506 Study Group. Japanese study of FK 506 on kidney transplantation: results of an early phase II study. Japa-nese FK 506 Study Group. Transplant Proc. 1991;23: 3071–4.
   Google Scholar
• Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE, et al. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002;46:2287–93.
   Google Scholar
• Komano Y, Tanaka M, Nanki T, Koike R, Sakai R, Kameda H, et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for long-term safety. J Rheumatol. 2011;38: 1258–64.
   PubMed Web of Science ®Google Scholar
• Sakai R, Komano Y, Tanaka M, Nanki T, Koike R, Nagasawa H, et al. Time-dependent increased risk for serious infection from continuous use of TNF antagonists during three years in rheu-matoid arthritis patients. Arthritis Care Res (Hoboken). 2012;64:1125–34.
   PubMed Web of Science ®Google Scholar
• Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum. 2005;52: 3403–12.
   PubMed Web of Science ®Google Scholar
• Dixon WG, Watson K, Lunt M, Hyrich KL, Silman AJ, Symmons DP, et al. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2006;54:2368–76.
   PubMed Web of Science ®Google Scholar
• Au K, Reed G, Curtis JR, Kremer JM, Greenberg JD, Strand V, et al. High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70:785–91.
   PubMed Web of Science ®Google Scholar
• Galloway JB, Mercer LK, Moseley A, Dixon WG, Ustianowski AP, Helbert M, et al. Risk of skin and soft tissue infections (including shingles) in patients exposed to anti-tumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis Published Online First: 24 April 2012.
   Google Scholar
• Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum. 2002;46:2294–300.
   PubMed Web of Science ®Google Scholar
• Wolfe F, Caplan L, Michaud K. Treatment for rheumatoid arthritis and the risk of hospitalization for pneumonia: associa-tions with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy. Arthritis Rheum. 2006;54:628–34.
   Google Scholar
• Curtis JR, Patkar N, Xie A, Martin C, Allison JJ, Saag M, et al. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor a antagonists. Arthritis Rheum. 2007;56:1125–33.
   PubMed Web of Science ®Google Scholar
• Dixon WG, Abrahamowicz M, Beauchamp ME, Ray DW, Ber-natsky S, Suissa S, et al. Immediate and delayed impact of oral glucocorticoid therapy on risk of serious infection in older patients with rheumatoid arthritis: a nested case-control analysis. Ann Rheum Dis. 2012;71:1128–33.
   Google Scholar
• Strangfeld A, Eveslage M, Schneider M, Bergerhausen HJ, Klopsch T, Zink A, et al. Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient? Ann Rheum Dis. 2011;70:1914–20.
   Google Scholar
• Kitahama M, Okamoto H, Koseki Y, Inoue E, Kaneko H, Tan-iguchi A, et al. Efficacy and safety of tacrolimus in 101 con-secutive patients with rheumatoid arthritis. Mod Rheumatol. 2010;20: 478–85.
   Google Scholar
• Koike R, Tanaka M, Komano Y, Sakai F, Sugiyama H, Nanki T, et al. Tacrolimus-induced pulmonary injury in rheumatoid arthritis patients. Pulm Pharmacol Ther. 2011;24:401–6.
   PubMedGoogle Scholar
• Visser K, van der Heijde DM. Risk and management of liver toxicity during methotrexate treatment in rheumatoid and psori-atic arthritis: a systematic review of the literature. Clin Exp Rheumatol. 2009;27:1017–25.
   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;68:1100–4.
   PubMed Web of Science ®Google Scholar
• Pavy S, Constantin A, Pham T, Gossec L, Maillefert JF, Canta-grel A, et al. Methotrexate therapy for rheumatoid arthritis: clinical practice guidelines based on published evidence and expert opinion. Joint Bone Spine. 2006;73:388–95.
   Google Scholar
• Visser K, Katchamart W, Loza E, Martinez-Lopez JA, Salliot C, Trudeau J, et al. Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatol-ogists in the 3E Initiative. Ann Rheum Dis. 2009;68: 1086–93.
   Google Scholar
• Morita Y, Sasae Y, Sakuta T, Satoh M, Sasaki T, Kashihara N. Efficacy of low-dose tacrolimus added to methotrexate in patients with rheumatoid arthritis in Japan: a retrospective study. Mod Rheumatol. 2008;18:379–84.
   PubMed Web of Science ®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. Arthritis Rheum. 2003;48:2763–8.
   PubMed Web of Science ®Google Scholar