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Volumn 66, Issue 3, 2014, Pages 344-354

Phase III study of the efficacy and safety of subcutaneous versus intravenous tocilizumab monotherapy in patients with rheumatoid arthritis

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CHOLESTEROL; DRUG ANTIBODY; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TOCILIZUMAB;

EID: 84896689880     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.22110     Document Type: Article
Times cited : (126)

References (32)
  • 1
    • 40749114497 scopus 로고    scopus 로고
    • Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): A double-blind, placebo-controlled, randomised trial
    • Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet 2008; 371: 987-97.
    • (2008) Lancet , vol.371 , pp. 987-997
    • Smolen, J.S.1    Beaulieu, A.2    Rubbert-Roth, A.3    Ramos-Remus, C.4    Rovensky, J.5    Alecock, E.6
  • 2
    • 54949150604 scopus 로고    scopus 로고
    • Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: The Tocilizumab in Combination with Traditional Disease-Modifying Antirheumatic Drug Therapy Study
    • Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the Tocilizumab in Combination With Traditional Disease-Modifying Antirheumatic Drug Therapy Study. Arthritis Rheum 2008; 58: 2968-80.
    • (2008) Arthritis Rheum , vol.58 , pp. 2968-2980
    • Genovese, M.C.1    McKay, J.D.2    Nasonov, E.L.3    Mysler, E.F.4    Da Silva, N.A.5    Alecock, E.6
  • 3
    • 52149099504 scopus 로고    scopus 로고
    • IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: Results from a 24-week multicentre randomised placebo-controlled trial
    • Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis 2008; 67: 1516-23.
    • (2008) Ann Rheum Dis , vol.67 , pp. 1516-1523
    • Emery, P.1    Keystone, E.2    Tony, H.P.3    Cantagrel, A.4    Van Vollenhoven, R.5    Sanchez, A.6
  • 4
    • 79953680176 scopus 로고    scopus 로고
    • Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: Results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year
    • Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum 2011; 63: 609-21.
    • (2011) Arthritis Rheum , vol.63 , pp. 609-621
    • Kremer, J.M.1    Blanco, R.2    Brzosko, M.3    Burgos-Vargas, R.4    Halland, A.M.5    Vernon, E.6
  • 5
    • 73449118587 scopus 로고    scopus 로고
    • Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study
    • Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis 2010; 69: 88-96.
    • (2010) Ann Rheum Dis , vol.69 , pp. 88-96
    • Jones, G.1    Sebba, A.2    Gu, J.3    Lowenstein, M.B.4    Calvo, A.5    Gomez-Reino, J.J.6
  • 6
    • 34447300492 scopus 로고    scopus 로고
    • 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
    • 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: 1162-7.
    • (2007) Ann Rheum Dis , vol.66 , pp. 1162-1167
    • Nishimoto, N.1    Hashimoto, J.2    Miyasaka, N.3    Yamamoto, K.4    Kawai, S.5    Takeuchi, T.6
  • 7
    • 60149105639 scopus 로고    scopus 로고
    • Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): Significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy
    • Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol 2009; 19: 12-9.
    • (2009) Mod Rheumatol , vol.19 , pp. 12-19
    • Nishimoto, N.1    Miyasaka, N.2    Yamamoto, K.3    Kawai, S.4    Takeuchi, T.5    Azuma, J.6
  • 9
    • 84871093047 scopus 로고    scopus 로고
    • Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY)
    • Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis 2013; 72: 43-50.
    • (2013) Ann Rheum Dis , vol.72 , pp. 43-50
    • Dougados, M.1    Kissel, K.2    Sheeran, T.3    Tak, P.P.4    Conaghan, P.G.5    Mola, E.M.6
  • 10
    • 84859832981 scopus 로고    scopus 로고
    • 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
    • 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 (Hoboken) 2012; 64: 625-39.
    • (2012) Arthritis Care Res (Hoboken) , vol.64 , pp. 625-639
    • Singh, J.A.1    Furst, D.E.2    Bharat, A.3    Curtis, J.R.4    Kavanaugh, A.F.5    Kremer, J.M.6
  • 11
    • 77953696525 scopus 로고    scopus 로고
    • EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs
    • Smolen JS, Landewe 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: 964-75.
    • (2010) Ann Rheum Dis , vol.69 , pp. 964-975
    • Smolen, J.S.1    Landewe, R.2    Breedveld, F.C.3    Dougados, M.4    Emery, P.5    Gaujoux-Viala, C.6
  • 12
    • 78049288337 scopus 로고    scopus 로고
    • Patient preferences and satisfaction in the treatment of rheumatoid arthritis with biologic therapy
    • Barton JL,. Patient preferences and satisfaction in the treatment of rheumatoid arthritis with biologic therapy. Patient Prefer Adherence 2009; 3: 335-44.
    • (2009) Patient Prefer Adherence , vol.3 , pp. 335-344
    • Barton, J.L.1
  • 13
    • 45149127659 scopus 로고    scopus 로고
    • Treatment choices, preferences and decision-making by patients with rheumatoid arthritis
    • Chilton F, Collett RA,. Treatment choices, preferences and decision-making by patients with rheumatoid arthritis. Musculoskeletal Care 2008; 6: 1-14.
    • (2008) Musculoskeletal Care , vol.6 , pp. 1-14
    • Chilton, F.1    Collett, R.A.2
  • 14
    • 33751413085 scopus 로고    scopus 로고
    • Patient preferences in choosing anti-TNF therapies-R1
    • [letter
    • Williams EL, Edwards CJ,. Patient preferences in choosing anti-TNF therapies-R1 [letter]. Rheumatology (Oxford) 2006; 45: 1575-6.
    • (2006) Rheumatology (Oxford) , vol.45 , pp. 1575-1576
    • Williams, E.L.1    Edwards, C.J.2
  • 15
    • 84896831026 scopus 로고    scopus 로고
    • Optimal dose prediction by pharmacokinetic and biomarker response of subcutaneous tocilizumab treatment: A phase I/II study evaluating the safety, pharmacokinetics and clinical response in patients with rheumatoid arthritis
    • [abstract
    • Ohta S, Tsuru T, Terao K, Mogi S, Suzaki M, Nakashima H, et al. Optimal dose prediction by pharmacokinetic and biomarker response of subcutaneous tocilizumab treatment: a phase I/II study evaluating the safety, pharmacokinetics and clinical response in patients with rheumatoid arthritis [abstract]. Arthritis Rheum 2010; 62 Suppl: S467-8.
    • (2010) Arthritis Rheum , vol.62 , Issue.SUPPL.
    • Ohta, S.1    Tsuru, T.2    Terao, K.3    Mogi, S.4    Suzaki, M.5    Nakashima, H.6
  • 16
    • 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
  • 17
    • 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    Anderson, J.J.2    Boers, M.3    Bombardier, C.4    Furst, D.5    Goldsmith, C.6
  • 18
    • 0346220231 scopus 로고    scopus 로고
    • Validation of a Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with rheumatoid arthritis
    • Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, et al. Validation of a Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with rheumatoid arthritis. Arthritis Rheum 2003; 49: 784-8.
    • (2003) Arthritis Rheum , vol.49 , pp. 784-788
    • Matsuda, Y.1    Singh, G.2    Yamanaka, H.3    Tanaka, E.4    Urano, W.5    Taniguchi, A.6
  • 19
    • 58149154996 scopus 로고    scopus 로고
    • Mechanisms and pathologic significances in increase in serum interleukin-6 (IL-6) and soluble IL-6 receptor after administration of an anti-IL-6 receptor antibody, tocilizumab, in patients with rheumatoid arthritis and Castleman's disease
    • Nishimoto N, Terao K, Mima T, Nakahara H, Takagi N, Kakehi T,. Mechanisms and pathologic significances in increase in serum interleukin-6 (IL-6) and soluble IL-6 receptor after administration of an anti-IL-6 receptor antibody, tocilizumab, in patients with rheumatoid arthritis and Castleman's disease. Blood 2008; 112: 3959-64.
    • (2008) Blood , vol.112 , pp. 3959-3964
    • Nishimoto, N.1    Terao, K.2    Mima, T.3    Nakahara, H.4    Takagi, N.5    Kakehi, T.6
  • 20
    • 77958165601 scopus 로고    scopus 로고
    • Subset analysis of patients experiencing clinical events of a potentially immunogenic nature in the pivotal clinical trials of tocilizumab for rheumatoid arthritis: Evaluation of an antidrug antibody ELISA using clinical adverse event-driven immunogenicity testing
    • Stubenrauch K, Wessels U, Birnboeck H, Ramirez F, Jahreis A, Schleypen J,. Subset analysis of patients experiencing clinical events of a potentially immunogenic nature in the pivotal clinical trials of tocilizumab for rheumatoid arthritis: evaluation of an antidrug antibody ELISA using clinical adverse event-driven immunogenicity testing. Clin Ther 2010; 32: 1597-609.
    • (2010) Clin Ther , vol.32 , pp. 1597-1609
    • Stubenrauch, K.1    Wessels, U.2    Birnboeck, H.3    Ramirez, F.4    Jahreis, A.5    Schleypen, J.6
  • 21
    • 0033566769 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline: Statistical principles for clinical trials
    • International Conference on Harmonisation E9 Expert Working Group.
    • International Conference on Harmonisation E9 Expert Working Group. ICH Harmonised Tripartite Guideline: statistical principles for clinical trials. Stat Med 1999; 18: 1905-42.
    • (1999) Stat Med , vol.18 , pp. 1905-1942
  • 22
    • 84892481998 scopus 로고    scopus 로고
    • A randomized, double-blind, parallel group study of the safety and efficacy of tocilizumab SC versus tocilizumab IV, in combination with traditional Dmards in patients with moderate to severe RA
    • [abstract
    • Burmester GR, Rubbert-Roth A, Cantagrel AG, Hall S, Leszczynski P, Feldman D, et al. A randomized, double-blind, parallel group study of the safety and efficacy of tocilizumab SC versus tocilizumab IV, in combination with traditional Dmards in patients with moderate to severe RA [abstract]. Arthritis Rheum 2012; 64 Suppl: S1075.
    • (2012) Arthritis Rheum , vol.64 , Issue.SUPPL.
    • Burmester, G.R.1    Rubbert-Roth, A.2    Cantagrel, A.G.3    Hall, S.4    Leszczynski, P.5    Feldman, D.6
  • 23
    • 84896838276 scopus 로고    scopus 로고
    • A randomized, double-blind, parallel-group study of the safety and efficacy of tocilizumab subcutaneous versus placebo in combination with traditional DMARDs in patients with moderate to severe rheumatoid arthritis (BREVACTA). Presented at the 76th Annual Scientific Meeting of the American College of Rheumatology; November 9-14; Washington, DC.
    • Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Rowell L, et al. A randomized, double-blind, parallel-group study of the safety and efficacy of tocilizumab subcutaneous versus placebo in combination with traditional DMARDs in patients with moderate to severe rheumatoid arthritis (BREVACTA). Presented at the 76th Annual Scientific Meeting of the American College of Rheumatology; 2012 November 9-14; Washington, DC.
    • (2012)
    • Kivitz, A.1    Olech, E.2    Borofsky, M.3    Zazueta, B.M.4    Navarro-Sarabia, F.5    Rowell, L.6
  • 24
    • 79959685613 scopus 로고    scopus 로고
    • Genentech, Inc.(a member of the Roche Group). South San Francisco: Genentech.
    • Genentech, Inc.(a member of the Roche Group). Actemra prescribing information. South San Francisco: Genentech; 2010.
    • (2010) Actemra Prescribing Information
  • 25
    • 84860908371 scopus 로고    scopus 로고
    • Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: Results of the GO-FORTH study
    • 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: 817-24.
    • (2012) Ann Rheum Dis , vol.71 , pp. 817-824
    • Tanaka, Y.1    Harigai, M.2    Takeuchi, T.3    Yamanaka, H.4    Ishiguro, N.5    Yamamoto, K.6
  • 26
    • 46549084098 scopus 로고    scopus 로고
    • Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: The CHANGE study
    • the CHANGE Study Investigators.
    • Miyasaka N, and the CHANGE Study Investigators. Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Mod Rheumatol 2008; 18: 252-62.
    • (2008) Mod Rheumatol , vol.18 , pp. 252-262
    • Miyasaka, N.1
  • 27
    • 84883197280 scopus 로고    scopus 로고
    • A retrospective study of serum KL-6 levels during treatment with biological disease-modifying antirheumatic drugs in rheumatoid arthritis patients: A report from the Ad Hoc Committee for Safety of Biological DMARDs of the Japan College of Rheumatology
    • Takamura A, Hirata S, Nagasawa H, Kameda H, Seto Y, Atsumi T, et al. A retrospective study of serum KL-6 levels during treatment with biological disease-modifying antirheumatic drugs in rheumatoid arthritis patients: a report from the Ad Hoc Committee for Safety of Biological DMARDs of the Japan College of Rheumatology. Mod Rheumatol 2013; 23: 297-303.
    • (2013) Mod Rheumatol , vol.23 , pp. 297-303
    • Takamura, A.1    Hirata, S.2    Nagasawa, H.3    Kameda, H.4    Seto, Y.5    Atsumi, T.6
  • 28
    • 84883143578 scopus 로고    scopus 로고
    • Elevation of KL-6 serum levels in clinical trials of tumor necrosis factor inhibitors in patients with rheumatoid arthritis: A report from the Japan College of Rheumatology Ad Hoc Committee for Safety of Biological DMARDs
    • Harigai M, Takamura A, Atsumi T, Dohi M, Hirata S, Kameda H, et al. Elevation of KL-6 serum levels in clinical trials of tumor necrosis factor inhibitors in patients with rheumatoid arthritis: a report from the Japan College of Rheumatology Ad Hoc Committee for Safety of Biological DMARDs. Mod Rheumatol 2013; 23: 284-96.
    • (2013) Mod Rheumatol , vol.23 , pp. 284-296
    • Harigai, M.1    Takamura, A.2    Atsumi, T.3    Dohi, M.4    Hirata, S.5    Kameda, H.6
  • 29
    • 34347267600 scopus 로고    scopus 로고
    • Clinical response to adalimumab: Relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis
    • Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007; 66: 921-6.
    • (2007) Ann Rheum Dis , vol.66 , pp. 921-926
    • Bartelds, G.M.1    Wijbrandts, C.A.2    Nurmohamed, M.T.3    Stapel, S.4    Lems, W.F.5    Aarden, L.6
  • 30
    • 77951548027 scopus 로고    scopus 로고
    • Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: A cohort study
    • Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al. Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 2010; 69: 817-21.
    • (2010) Ann Rheum Dis , vol.69 , pp. 817-821
    • Bartelds, G.M.1    Wijbrandts, C.A.2    Nurmohamed, M.T.3    Stapel, S.4    Lems, W.F.5    Aarden, L.6
  • 31
    • 33947594031 scopus 로고    scopus 로고
    • The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis
    • Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, et al. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol 2007; 25: 40-6.
    • (2007) Clin Exp Rheumatol , vol.25 , pp. 40-46
    • Dore, R.K.1    Mathews, S.2    Schechtman, J.3    Surbeck, W.4    Mandel, D.5    Patel, A.6
  • 32
    • 82955189834 scopus 로고    scopus 로고
    • Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: Impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase IIIb ALLOW study)
    • Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, et al. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase IIIb ALLOW study). Ann Rheum Dis 2012; 71: 38-44.
    • (2012) Ann Rheum Dis , vol.71 , pp. 38-44
    • Kaine, J.1    Gladstein, G.2    Strusberg, I.3    Robles, M.4    Louw, I.5    Gujrathi, S.6


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