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Volumn 67, Issue 10, 2015, Pages 2591-2600

The Efficacy and Safety of Subcutaneous Clazakizumab in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results From a Multinational, Phase IIb, Randomized, Double-Blind, Placebo/Active-Controlled, Dose-Ranging Study

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRHEUMATIC AGENT; CLAZAKIZUMAB; INTERLEUKIN 6; METHOTREXATE; MONOCLONAL ANTIBODY;

EID: 84958092782     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/ART.39249     Document Type: Article
Times cited : (91)

References (29)
  • 1
    • 84869797922 scopus 로고    scopus 로고
    • IL-6 trans-signaling via the soluble IL-6 receptor: Importance for the pro-inflammatory activities of IL-6
    • Rose-John S. IL-6 trans-signaling via the soluble IL-6 receptor: Importance for the pro-inflammatory activities of IL-6. Int J Biol Sci 2012;8:1237-47.
    • (2012) Int J Biol Sci , vol.8 , pp. 1237-1247
    • Rose-John, S.1
  • 2
    • 0037105542 scopus 로고    scopus 로고
    • IL-6, leukemia inhibitory factor, and oncostatin M stimulate bone resorption and regulate the expression of receptor activator of NF-kB ligand, osteoprotegerin, and receptor activator of NF-kB in mouse calvariae
    • Palmqvist P, Persson E, Conaway HH, Lerner UH. IL-6, leukemia inhibitory factor, and oncostatin M stimulate bone resorption and regulate the expression of receptor activator of NF-kB ligand, osteoprotegerin, and receptor activator of NF-kB in mouse calvariae. J Immunol 2002;169:3353-62.
    • (2002) J Immunol , vol.169 , pp. 3353-3362
    • Palmqvist, P.1    Persson, E.2    Conaway, H.H.3    Lerner, U.H.4
  • 3
    • 77955096184 scopus 로고    scopus 로고
    • Therapeutic targets in rheumatoid arthritis: The interleukin-6 receptor
    • Dayer JM, Choy E. Therapeutic targets in rheumatoid arthritis: The interleukin-6 receptor. Rheumatology (Oxford) 2010;49:15-24.
    • (2010) Rheumatology (Oxford) , vol.49 , pp. 15-24
    • Dayer, J.M.1    Choy, E.2
  • 4
    • 0037265995 scopus 로고    scopus 로고
    • Interleukin-6 and interleukin-11 support human osteoclast formation by a RANKL-independent mechanism
    • Kudo O, Sabokbar A, Pocock A, Itonaga I, Fujikawa Y, Athanasou NA. Interleukin-6 and interleukin-11 support human osteoclast formation by a RANKL-independent mechanism. Bone 2003;32:1-7.
    • (2003) Bone , vol.32 , pp. 1-7
    • Kudo, O.1    Sabokbar, A.2    Pocock, A.3    Itonaga, I.4    Fujikawa, Y.5    Athanasou, N.A.6
  • 5
    • 52949088264 scopus 로고    scopus 로고
    • Interleukin-6 inhibitors in the treatment of rheumatoid arthritis
    • Hennigan S, Kavanaugh A. Interleukin-6 inhibitors in the treatment of rheumatoid arthritis. Ther Clin Risk Manag 2008;4: 767-75.
    • (2008) Ther Clin Risk Manag , vol.4 , pp. 767-775
    • Hennigan, S.1    Kavanaugh, A.2
  • 6
    • 0027305079 scopus 로고
    • Interleukin-6 in synovial fluid is closely associated with chronic synovitis in rheumatoid arthritis
    • Sack U, Kinne RW, Marx T, Heppt P, Bender S, Emmrich F. Interleukin-6 in synovial fluid is closely associated with chronic synovitis in rheumatoid arthritis. Rheumatol Int 1993;13:45-51.
    • (1993) Rheumatol Int , vol.13 , pp. 45-51
    • Sack, U.1    Kinne, R.W.2    Marx, T.3    Heppt, P.4    Bender, S.5    Emmrich, F.6
  • 7
    • 33749008494 scopus 로고    scopus 로고
    • Interleukin-6 levels in synovial fluids of patients with rheumatoid arthritis correlated with the infiltration of inflammatory cells in synovial membrane
    • Matsumoto T, Tsurumoto T, Shindo H. Interleukin-6 levels in synovial fluids of patients with rheumatoid arthritis correlated with the infiltration of inflammatory cells in synovial membrane. Rheumatol Int 2006;26:1096-100.
    • (2006) Rheumatol Int , vol.26 , pp. 1096-1100
    • Matsumoto, T.1    Tsurumoto, T.2    Shindo, H.3
  • 8
    • 0031744306 scopus 로고    scopus 로고
    • Serum levels of interleukin-6 type cytokines and soluble interleukin-6 receptor in patients with rheumatoid arthritis
    • Robak T, Gladalska A, Stepien H, Robak E. Serum levels of interleukin-6 type cytokines and soluble interleukin-6 receptor in patients with rheumatoid arthritis. Mediators Inflamm 1998;7:347-53.
    • (1998) Mediators Inflamm , vol.7 , pp. 347-353
    • Robak, T.1    Gladalska, A.2    Stepien, H.3    Robak, E.4
  • 9
    • 84896495791 scopus 로고    scopus 로고
    • A new era for the treatment of inflammatory autoimmune diseases by interleukin-6 blockade strategy
    • Tanaka T, Narazaki M, Ogata A, Kishimoto T. A new era for the treatment of inflammatory autoimmune diseases by interleukin-6 blockade strategy. Semin Immunol 2014;26:88-96.
    • (2014) Semin Immunol , vol.26 , pp. 88-96
    • Tanaka, T.1    Narazaki, M.2    Ogata, A.3    Kishimoto, T.4
  • 10
    • 84896974848 scopus 로고    scopus 로고
    • Anti-IL-6 antibody clazakizumab is more potent than tocilizumab in blocking in vitro and ex vivo IL-6-induced functions [abstract]
    • Zhao Q, Pang J, Shuster D, Hung C, Baglino S, Dodge R, et al. Anti-IL-6 antibody clazakizumab is more potent than tocilizumab in blocking in vitro and ex vivo IL-6-induced functions [abstract]. Arthritis Rheum 2013; 65 Suppl:S1020.
    • (2013) Arthritis Rheum , vol.65
    • Zhao, Q.1    Pang, J.2    Shuster, D.3    Hung, C.4    Baglino, S.5    Dodge, R.6
  • 11
    • 84862783578 scopus 로고    scopus 로고
    • A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate
    • Mease P, Strand V, Shalamberidze L, Dimic A, Raskina T, Xu LA, et al. A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate. Ann Rheum Dis 2012;71:1183-9.
    • (2012) Ann Rheum Dis , vol.71 , pp. 1183-1189
    • Mease, P.1    Strand, V.2    Shalamberidze, L.3    Dimic, A.4    Raskina, T.5    Xu, L.A.6
  • 12
    • 81155138345 scopus 로고    scopus 로고
    • Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): Results from the CanACT study
    • Haraoui B, Cividino A, Stewart J, Guerette B, Keystone EC. Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): Results from the CanACT study. BMC Musculoskelet Disord 2011;12:261.
    • (2011) BMC Musculoskelet Disord , vol.12 , pp. 261
    • Haraoui, B.1    Cividino, A.2    Stewart, J.3    Guerette, B.4    Keystone, E.C.5
  • 13
    • 0023945481 scopus 로고
    • The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis
    • 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;31:315-24.
    • (1988) Arthritis Rheum , vol.31 , pp. 315-324
    • Arnett, F.C.1    Edworthy, S.M.2    Bloch, D.A.3    McShane, D.J.4    Fries, J.F.5    Cooper, N.S.6
  • 14
    • 77956055481 scopus 로고    scopus 로고
    • Rheumatoid arthritis classification criteria: An American College of Rheumatology/European League Against Rheumatism collaborative initiative
    • Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, et al. 2010 Rheumatoid arthritis classification criteria: An American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 2010; 62:2569-81.
    • (2010) Arthritis Rheum , vol.62 , pp. 2569-2581
    • Aletaha, D.1    Neogi, T.2    Silman, A.J.3    Funovits, J.4    Felson, D.T.5    Bingham, C.O.6
  • 15
    • 0026629688 scopus 로고
    • The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis
    • 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.
    • (1992) Arthritis Rheum , vol.35 , pp. 498-502
    • Hochberg, M.C.1    Chang, R.W.2    Dwosh, I.3    Lindsey, S.4    Pincus, T.5    Wolfe, F.6
  • 16
    • 0029044362 scopus 로고
    • American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis
    • 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;38:727-35.
    • (1995) Arthritis Rheum , vol.38 , pp. 727-735
    • Felson, D.T.1    Erson, J.J.2    Boers, M.3    Bombardier, C.4    Furst, D.5    Goldsmith, C.6
  • 17
    • 0027238592 scopus 로고
    • The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials
    • Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum 1993;36:729-40.
    • (1993) Arthritis Rheum , vol.36 , pp. 729-740
    • Felson, D.T.1    Erson, J.J.2    Boers, M.3    Bombardier, C.4    Chernoff, M.5    Fried, B.6
  • 18
    • 0028815803 scopus 로고
    • Modified disease activity scores that include twenty-eight-joint counts: Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis
    • 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.
    • (1995) Arthritis Rheum , vol.38 , pp. 44-48
    • Prevoo, M.L.1    Van’T Hof, M.A.2    Kuper, H.H.3    Van Leeuwen, M.A.4    Van De Putte, L.B.5    Van Riel, P.L.6
  • 19
    • 23944478301 scopus 로고    scopus 로고
    • Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: Validation of a clinical activity score
    • 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.
    • (2005) Arthritis Res Ther , vol.7 , pp. R796-R806
    • Aletaha, D.1    Nell, V.P.2    Stamm, T.3    Uffmann, M.4    Pflugbeil, S.5    Machold, K.6
  • 21
    • 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
  • 23
    • 70349402169 scopus 로고    scopus 로고
    • Long-term safety and efficacy of tocilizumab, an antiIL-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
    • Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J. Long-term safety and efficacy of tocilizumab, an antiIL-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.
    • (2009) Ann Rheum Dis , vol.68 , pp. 1580-1584
    • Nishimoto, N.1    Miyasaka, N.2    Yamamoto, K.3    Kawai, S.4    Takeuchi, T.5    Azuma, J.6
  • 24
    • 84893733932 scopus 로고    scopus 로고
    • Interleukin 6 and rheumatoid arthritis
    • Yoshida Y, Tanaka T. Interleukin 6 and rheumatoid arthritis. Biomed Res Int 2014;2014:698313.
    • (2014) Biomed Res Int , vol.2014
    • Yoshida, Y.1    Tanaka, T.2
  • 26
    • 84905179575 scopus 로고    scopus 로고
    • Sarilumab, a fully human monoclonal antibody against IL-6Ra in patients with rheumatoid arthritis and an inadequate response to methotrexate: Efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial
    • Huizinga TW, Fleischmann RM, Jasson M, Radin AR, van Adelsberg J, Fiore S, et al. Sarilumab, a fully human monoclonal antibody against IL-6Ra in patients with rheumatoid arthritis and an inadequate response to methotrexate: Efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis 2014;73:1626-34.
    • (2014) Ann Rheum Dis , vol.73 , pp. 1626-1634
    • Huizinga, T.W.1    Fleischmann, R.M.2    Jasson, M.3    Radin, A.R.4    Van Adelsberg, J.5    Fiore, S.6
  • 27
    • 84905192115 scopus 로고    scopus 로고
    • Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: Outcomes of a randomised Phase IIb study
    • Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, et al. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: Outcomes of a randomised Phase IIb study. Ann Rheum Dis 2014;73:1607-15.
    • (2014) Ann Rheum Dis , vol.73 , pp. 1607-1615
    • Genovese, M.C.1    Fleischmann, R.2    Furst, D.3    Janssen, N.4    Carter, J.5    Dasgupta, B.6
  • 28
    • 84925670384 scopus 로고    scopus 로고
    • Effect of interleukin-6 receptor blockade on surrogates of vascular risk in rheumatoid arthritis: MEASURE, a randomised, placebo-controlled study
    • McInnes IB, Thompson L, Giles JT, Bathon JM, Salmon JE, Beaulieu AD, et al. Effect of interleukin-6 receptor blockade on surrogates of vascular risk in rheumatoid arthritis: MEASURE, a randomised, placebo-controlled study. Ann Rheum Dis 2013; 74:694-702.
    • (2013) Ann Rheum Dis , vol.74 , pp. 694-702
    • McInnes, I.B.1    Thompson, L.2    Giles, J.T.3    Bathon, J.M.4    Salmon, J.E.5    Beaulieu, A.D.6
  • 29
    • 0037231533 scopus 로고    scopus 로고
    • Adalimumab, a fully human anti-tumor necrosis factor a monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial
    • Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor a monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial. Arthritis Rheum 2003;48:35-45.
    • (2003) Arthritis Rheum , vol.48 , pp. 35-45
    • Weinblatt, M.E.1    Keystone, E.C.2    Furst, D.E.3    Moreland, L.W.4    Weisman, M.H.5    Birbara, C.A.6


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