메뉴 건너뛰기




Volumn 28, Issue 1, 2018, Pages 48-57

Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan

Author keywords

Add on therapy; biological DMARDs; post marketing surveillance; rheumatoid arthritis; tacrolimus

Indexed keywords

ABATACEPT; ADALIMUMAB; C REACTIVE PROTEIN; CERTOLIZUMAB PEGOL; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; METHOTREXATE; STROMELYSIN; TACROLIMUS; TOCILIZUMAB; ANTIRHEUMATIC AGENT;

EID: 85021298380     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.1080/14397595.2017.1332471     Document Type: Article
Times cited : (16)

References (38)
  • 1
    • 84855172814 scopus 로고    scopus 로고
    • The pathogenesis of rheumatoid arthritis
    • McInnes IB, Schett G., The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011;365:2205–19.
    • (2011) N Engl J Med , vol.365 , pp. 2205-2219
    • McInnes, I.B.1    Schett, G.2
  • 2
    • 20244372077 scopus 로고    scopus 로고
    • Therapeutic strategies for rheumatoid arthritis
    • O'Dell JR., Therapeutic strategies for rheumatoid arthritis. N Engl J Med. 2004;350:2591–602.
    • (2004) N Engl J Med , vol.350 , pp. 2591-2602
    • O'Dell, J.R.1
  • 3
    • 33745819196 scopus 로고    scopus 로고
    • Methotrexate therapy for rheumatoid arthritis: clinical practice guidelines based on published evidence and expert opinion
    • Pavy S, Constantin A, Pham T, Gossec L, Maillefert JF, Cantagrel 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.
    • (2006) Joint Bone Spine , vol.73 , pp. 388-395
    • Pavy, S.1    Constantin, A.2    Pham, T.3    Gossec, L.4    Maillefert, J.F.5    Cantagrel, A.6
  • 4
    • 76649094231 scopus 로고    scopus 로고
    • Risk and management of liver toxicity during methotrexate treatment in rheumatoid and psoriatic arthritis: a systematic review of the literature
    • Visser K, van der Heijde DM., Risk and management of liver toxicity during methotrexate treatment in rheumatoid and psoriatic arthritis: a systematic review of the literature. Clin Exp Rheumatol. 2009;27:1017–25.
    • (2009) Clin Exp Rheumatol , vol.27 , pp. 1017-1025
    • Visser, K.1    van der Heijde, D.M.2
  • 5
    • 67549107120 scopus 로고    scopus 로고
    • Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research
    • 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.
    • (2009) Ann Rheum Dis , vol.68 , pp. 1100-1104
    • Salliot, C.1    van der Heijde, D.2
  • 6
    • 67549096874 scopus 로고    scopus 로고
    • 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 rheumatologists in the 3E Initiative
    • 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 rheumatologists in the 3E Initiative. Ann Rheum Dis. 2009;68:1086–93.
    • (2009) Ann Rheum Dis , vol.68 , pp. 1086-1093
    • Visser, K.1    Katchamart, W.2    Loza, E.3    Martinez-Lopez, J.A.4    Salliot, C.5    Trudeau, J.6
  • 8
    • 84858999548 scopus 로고    scopus 로고
    • Biologicals for rheumatoid arthritis
    • Tugwell P, Singh JA, Wells GA., Biologicals for rheumatoid arthritis. BMJ. 2011;343:d4027.
    • (2011) BMJ , vol.343 , pp. d4027
    • Tugwell, P.1    Singh, J.A.2    Wells, G.A.3
  • 9
    • 64549161956 scopus 로고    scopus 로고
    • Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review
    • Rubbert-Roth A, Finckh A., Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009;11(Suppl 1):S1.
    • (2009) Arthritis Res Ther , vol.11 , pp. S1
    • Rubbert-Roth, A.1    Finckh, A.2
  • 10
    • 75749099775 scopus 로고    scopus 로고
    • Recent advances in the genetics of rheumatoid arthritis
    • Raychaudhuri S., Recent advances in the genetics of rheumatoid arthritis. Curr Opin Rheumatol. 2010;22:109–18.
    • (2010) Curr Opin Rheumatol , vol.22 , pp. 109-118
    • Raychaudhuri, S.1
  • 11
    • 84894096187 scopus 로고    scopus 로고
    • T cell subsets and their role in the pathogenesis of rheumatic disease
    • Gizinski AM, Fox DA., T cell subsets and their role in the pathogenesis of rheumatic disease. Curr Opin Rheumatol. 2014;26:204–10.
    • (2014) Curr Opin Rheumatol , vol.26 , pp. 204-210
    • Gizinski, A.M.1    Fox, D.A.2
  • 12
    • 0038237028 scopus 로고    scopus 로고
    • Tacrolimus: a further update of its use in the management of organ transplantation
    • Scott LJ, McKeage K, Keam SJ, Plosker GL., Tacrolimus: a further update of its use in the management of organ transplantation. Drugs. 2003;63:1247–97.
    • (2003) Drugs , vol.63 , pp. 1247-1297
    • Scott, L.J.1    McKeage, K.2    Keam, S.J.3    Plosker, G.L.4
  • 13
    • 0036674871 scopus 로고    scopus 로고
    • Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with methotrexate: a six-month, double-blind, randomized, dose-ranging study
    • 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.
    • (2002) Arthritis Rheum , vol.46 , pp. 2020-2028
    • Furst, D.E.1    Saag, K.2    Fleischmann, M.R.3    Sherrer, Y.4    Block, J.A.5    Schnitzer, T.6
  • 14
    • 10744233211 scopus 로고    scopus 로고
    • Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial
    • 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;48:3328–37.
    • (2003) Arthritis Rheum , vol.48 , pp. 3328-3337
    • Yocum, D.E.1    Furst, D.E.2    Kaine, J.L.3    Baldassare, A.R.4    Stevenson, J.T.5    Borton, M.A.6
  • 15
    • 0742305108 scopus 로고    scopus 로고
    • Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dose-finding study
    • 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 controlled dose-finding study. J Rheumatol. 2004;31:243–51.
    • (2004) J Rheumatol , vol.31 , pp. 243-251
    • Kondo, H.1    Abe, T.2    Hashimoto, H.3    Uchida, S.4    Irimajiri, S.5    Hara, M.6
  • 16
    • 33750973069 scopus 로고    scopus 로고
    • Comparison of tacrolimus and mizoribine in a randomized, double-blind controlled study in patients with rheumatoid arthritis
    • 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.
    • (2006) J Rheumatol , vol.33 , pp. 2153-2161
    • Kawai, S.1    Hashimoto, H.2    Kondo, H.3    Murayama, T.4    Kiuchi, T.5    Abe, T.6
  • 17
    • 33645276306 scopus 로고    scopus 로고
    • Safety of tacrolimus, an immunosuppressive agent, in the treatment of rheumatoid arthritis in elderly patients
    • Kawai S, Yamamoto K., Safety of tacrolimus, an immunosuppressive agent, in the treatment of rheumatoid arthritis in elderly patients. Rheumatology (Oxford). 2006;45:441–4.
    • (2006) Rheumatology (Oxford) , vol.45 , pp. 441-444
    • Kawai, S.1    Yamamoto, K.2
  • 18
    • 84896867064 scopus 로고    scopus 로고
    • Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis
    • Takeuchi T, Kawai S, Yamamoto K, Harigai M, Ishida K, Miyasaka N., Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2014;24:8–16.
    • (2014) Mod Rheumatol , vol.24 , pp. 8-16
    • Takeuchi, T.1    Kawai, S.2    Yamamoto, K.3    Harigai, M.4    Ishida, K.5    Miyasaka, N.6
  • 19
    • 69049118111 scopus 로고    scopus 로고
    • Adding low dose tacrolimus in rheumatoid arthritis patients with an inadequate response to tumor necrosis factor inhibitor therapies
    • Naniwa T, Watanabe M, Banno S, Maeda T., Adding low dose tacrolimus in rheumatoid arthritis patients with an inadequate response to tumor necrosis factor inhibitor therapies. Rheumatol Int. 2009;29:1287–91.
    • (2009) Rheumatol Int , vol.29 , pp. 1287-1291
    • Naniwa, T.1    Watanabe, M.2    Banno, S.3    Maeda, T.4
  • 20
    • 84862252993 scopus 로고    scopus 로고
    • Effect of additional administration of tacrolimus in patients with rheumatoid arthritis treated with biologics
    • Miyata M, Asano T, Satoh S., Effect of additional administration of tacrolimus in patients with rheumatoid arthritis treated with biologics. Fukushima J Med Sci. 2011;57:54–9.
    • (2011) Fukushima J Med Sci , vol.57 , pp. 54-59
    • Miyata, M.1    Asano, T.2    Satoh, S.3
  • 21
    • 84870377175 scopus 로고    scopus 로고
    • Additional use of tacrolimus after switching to tocilizumab therapy in patients with primary lack of efficacy of infliximab therapy for rheumatoid arthritis
    • Mori S., Additional use of tacrolimus after switching to tocilizumab therapy in patients with primary lack of efficacy of infliximab therapy for rheumatoid arthritis. Mod Rheumatol. 2012;22:947–50.
    • (2012) Mod Rheumatol , vol.22 , pp. 947-950
    • Mori, S.1
  • 22
    • 84946831790 scopus 로고    scopus 로고
    • Comparison of efficacy and safety of tacrolimus and methotrexate in combination with abatacept in patients with rheumatoid arthritis; a retrospective observational study in the TBC Registry
    • Fujibayashi T, Takahashi N, Kida D, Kaneko A, Hirano Y, Fukaya N, et al. Comparison of efficacy and safety of tacrolimus and methotrexate in combination with abatacept in patients with rheumatoid arthritis; a retrospective observational study in the TBC Registry. Mod Rheumatol. 2015;25:825–30.
    • (2015) Mod Rheumatol , vol.25 , pp. 825-830
    • Fujibayashi, T.1    Takahashi, N.2    Kida, D.3    Kaneko, A.4    Hirano, Y.5    Fukaya, N.6
  • 23
    • 84941993345 scopus 로고    scopus 로고
    • Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use
    • Takahashi N, Fujibayashi T, Kida D, Hirano Y, Kato T, Kato D, et al. Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use. Rheumatol Int. 2015;35:1707–16.
    • (2015) Rheumatol Int , vol.35 , pp. 1707-1716
    • Takahashi, N.1    Fujibayashi, T.2    Kida, D.3    Hirano, Y.4    Kato, T.5    Kato, D.6
  • 24
    • 79953752083 scopus 로고    scopus 로고
    • American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials
    • Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum. 2011;63:573–86.
    • (2011) Arthritis Rheum , vol.63 , pp. 573-586
    • Felson, D.T.1    Smolen, J.S.2    Wells, G.3    Zhang, B.4    van Tuyl, L.H.5    Funovits, J.6
  • 26
    • 0037331240 scopus 로고    scopus 로고
    • Radiologic features in juvenile idiopathic arthritis: a first step in the development of a standardized assessment method
    • van Rossum MA, Zwinderman AH, Boers M, Dijkmans BA, van Soesbergen RM, Fiselier TJ, et al. Radiologic features in juvenile idiopathic arthritis: a first step in the development of a standardized assessment method. Arthritis Rheum. 2003;48:507–15.
    • (2003) Arthritis Rheum , vol.48 , pp. 507-515
    • van Rossum, M.A.1    Zwinderman, A.H.2    Boers, M.3    Dijkmans, B.A.4    van Soesbergen, R.M.5    Fiselier, T.J.6
  • 27
    • 48949117142 scopus 로고    scopus 로고
    • Measurement of biomarkers in juvenile idiopathic arthritis patients and their significant association with disease severity: a comparative study
    • Gilliam BE, Chauhan AK, Low JM, Moore TL., Measurement of biomarkers in juvenile idiopathic arthritis patients and their significant association with disease severity: a comparative study. Clin Exp Rheumatol. 2008;26:492–7.
    • (2008) Clin Exp Rheumatol , vol.26 , pp. 492-497
    • Gilliam, B.E.1    Chauhan, A.K.2    Low, J.M.3    Moore, T.L.4
  • 30
    • 34548152256 scopus 로고    scopus 로고
    • Disease Activity Score 28 (DAS28) using C-reactive protein underestimates disease activity and overestimates EULAR response criteria compared with DAS28 using erythrocyte sedimentation rate in a large observational cohort of rheumatoid arthritis patients in Japan
    • Matsui T, Kuga Y, Kaneko A, Nishino J, Eto Y, Chiba N, et al. Disease Activity Score 28 (DAS28) using C-reactive protein underestimates disease activity and overestimates EULAR response criteria compared with DAS28 using erythrocyte sedimentation rate in a large observational cohort of rheumatoid arthritis patients in Japan. Ann Rheum Dis. 2007;66:1221–6.
    • (2007) Ann Rheum Dis , vol.66 , pp. 1221-1226
    • Matsui, T.1    Kuga, Y.2    Kaneko, A.3    Nishino, J.4    Eto, Y.5    Chiba, N.6
  • 31
    • 34147194958 scopus 로고    scopus 로고
    • Comparison of Disease Activity Score (DAS)28-erythrocyte sedimentation rate and DAS28- C-reactive protein threshold values
    • Inoue E, Yamanaka H, Hara M, Tomatsu T, Kamatani N., Comparison of Disease Activity Score (DAS)28-erythrocyte sedimentation rate and DAS28- C-reactive protein threshold values. Ann Rheum Dis. 2007;66:407–9.
    • (2007) Ann Rheum Dis , vol.66 , pp. 407-409
    • Inoue, E.1    Yamanaka, H.2    Hara, M.3    Tomatsu, T.4    Kamatani, N.5
  • 32
    • 67449116863 scopus 로고    scopus 로고
    • Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate
    • Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009;68:954–60.
    • (2009) Ann Rheum Dis , vol.68 , pp. 954-960
    • Wells, G.1    Becker, J.C.2    Teng, J.3    Dougados, M.4    Schiff, M.5    Smolen, J.6
  • 33
    • 0021046385 scopus 로고
    • Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire
    • 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;26:1346–53.
    • (1983) Arthritis Rheum , vol.26 , pp. 1346-1353
    • Pincus, T.1    Summey, J.A.2    Soraci, S.A.3    Wallston, K.A.4    Hummon, N.P.5
  • 34
    • 0032699810 scopus 로고    scopus 로고
    • Serum levels of matrix metalloproteinase-3 in relation to the development of radiological damage in patients with early rheumatoid arthritis
    • Posthumus MD, Limburg PC, Westra J, Cats HA, Stewart RE, van Leeuwen MA, et al. Serum levels of matrix metalloproteinase-3 in relation to the development of radiological damage in patients with early rheumatoid arthritis. Rheumatology (Oxford). 1999;38:1081–7.
    • (1999) Rheumatology (Oxford) , vol.38 , pp. 1081-1087
    • Posthumus, M.D.1    Limburg, P.C.2    Westra, J.3    Cats, H.A.4    Stewart, R.E.5    van Leeuwen, M.A.6
  • 35
    • 0033863433 scopus 로고    scopus 로고
    • Serum matrix metalloproteinase 3 as a predictor of the degree of joint destruction during the six months after measurement, in patients with early rheumatoid arthritis
    • Yamanaka H, Matsuda Y, Tanaka M, Sendo W, Nakajima H, Taniguchi A, et al. Serum matrix metalloproteinase 3 as a predictor of the degree of joint destruction during the six months after measurement, in patients with early rheumatoid arthritis. Arthritis Rheum. 2000;43:852–8.
    • (2000) Arthritis Rheum , vol.43 , pp. 852-858
    • Yamanaka, H.1    Matsuda, Y.2    Tanaka, M.3    Sendo, W.4    Nakajima, H.5    Taniguchi, A.6
  • 36
    • 33644804877 scopus 로고    scopus 로고
    • The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): a review of their usefulness and validity in rheumatoid arthritis
    • Aletaha D, Smolen J., The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): a review of their usefulness and validity in rheumatoid arthritis. Clin Exp Rheumatol. 2005;23(Suppl 39):S100–S8.
    • (2005) Clin Exp Rheumatol , vol.23 , pp. S100-S108
    • Aletaha, D.1    Smolen, J.2
  • 37
    • 85041291899 scopus 로고    scopus 로고
    • Astellas Pharma Inc. [Japanese]
    • ® Capsules (tacrolimus). Astellas Pharma Inc. [Japanese].
  • 38
    • 84948584169 scopus 로고    scopus 로고
    • Evaluation of the safety and effectiveness of add-on tacrolimus in patients with rheumatoid arthritis who failed to show an adequate response to biological DMARDs: the interim results of a specific drug use-results survey of tacrolimus
    • Ishida K, Shiraki K, Yoshiyasu T., Evaluation of the safety and effectiveness of add-on tacrolimus in patients with rheumatoid arthritis who failed to show an adequate response to biological DMARDs: the interim results of a specific drug use-results survey of tacrolimus. Drugs R D. 2015;15:307–17.
    • (2015) Drugs R D , vol.15 , pp. 307-317
    • Ishida, K.1    Shiraki, K.2    Yoshiyasu, T.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.