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Volumn 73, Issue 6, 2014, Pages 990-999

Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebocontrolled, randomised PSUMMIT 2 trial

Author keywords

[No Author keywords available]

Indexed keywords

INTERLEUKIN 12 ANTIBODY; INTERLEUKIN 23 ANTIBODY; METHOTREXATE; PLACEBO; TUMOR NECROSIS FACTOR INHIBITOR; USTEKINUMAB;

EID: 84899991797     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2013-204655     Document Type: Article
Times cited : (568)

References (40)
  • 2
    • 47349088393 scopus 로고    scopus 로고
    • From skin to bone: Translational perspectives on psoriatic disease
    • Ritchlin CT. From skin to bone: translational perspectives on psoriatic disease. J Rheumatol 2008;35: 1434-7. (Pubitemid 352000800)
    • (2008) Journal of Rheumatology , vol.35 , Issue.7 , pp. 1434-1437
    • Ritchlin, C.T.1
  • 3
    • 0025800559 scopus 로고
    • Psoriatic arthritis (PsA): A clinical, immunological and radiological study of 180 Patients
    • Torre Alonso JC, Rodriguez Perez A, Arribas Castrillo JM, et al. Psoriatic arthritis (PsA): a clinical, immunological and radiological study of 180 Patients. Br J Rheumatol 1991;30: 245-50.
    • (1991) Br J Rheumatol , vol.30 , pp. 245-250
    • Torre Alonso, J.C.1    Rodriguez Perez, A.2    Arribas Castrillo, J.M.3
  • 4
    • 0034907770 scopus 로고    scopus 로고
    • Comparison of disability and quality of life in rheumatoid and psoriatic arthritis
    • Sokoll KB, Helliwell PS. Comparison of disability and quality of life in rheumatoid and psoriatic arthritis. J Rheumatol 2001;28: 1842-6. (Pubitemid 32726931)
    • (2001) Journal of Rheumatology , vol.28 , Issue.8 , pp. 1842-1846
    • Sokoll, K.B.1    Helliwell, P.S.2
  • 5
    • 0030767275 scopus 로고    scopus 로고
    • Mortality studies in psoriatic arthritis: Results from a single outpatient clinic. I. Causes and risk of death
    • DOI 10.1002/art.1780401021
    • Wong K, Gladman DD, Husted J, et al. Mortality studies in psoriatic arthritis. Results from a single outpatient clinic. I. Causes and risk of death. Arthritis Rheum 1997;40: 1868-72. (Pubitemid 27452539)
    • (1997) Arthritis and Rheumatism , vol.40 , Issue.10 , pp. 1868-1872
    • Wong, K.1    Gladman, D.D.2    Husted, J.3    Long, J.A.4    Farewell, V.T.5
  • 6
    • 0031802067 scopus 로고    scopus 로고
    • Mortality studies in psoriatic arthritis: Results from a single outpatient center. II. Prognostic indicators for death
    • DOI 10.1002/1529-0131(199806)41:6<1103::AID-ART18>3.0.CO;2-N
    • Gladman DD, Farewell VT, Wong K, et al. Mortality studies in psoriatic arthritis. Results from a single outpatient center. II. Prognostic indicators for death. Arthritis Rheum 1998;41: 1103-10. (Pubitemid 28265412)
    • (1998) Arthritis and Rheumatism , vol.41 , Issue.6 , pp. 1103-1110
    • Gladman, D.D.1    Farewell, V.T.2    Wong, K.3    Husted, J.4
  • 7
    • 79959600844 scopus 로고    scopus 로고
    • Prevalence of patient-reported comorbidities in early and established psoriatic arthritis cohorts
    • Khraishi M, MacDonald D, Rampakakis E, et al. Prevalence of patient-reported comorbidities in early and established psoriatic arthritis cohorts. Clin Rheumatol 2011;30: 877-85.
    • (2011) Clin Rheumatol , vol.30 , pp. 877-885
    • Khraishi, M.1    Macdonald, D.2    Rampakakis, E.3
  • 8
    • 84856529650 scopus 로고    scopus 로고
    • Comorbidities of psoriatic arthritis-metabolic syndrome and prevention: A report from the GRAPPA 2010 Annual Meeting
    • Raychaudhuri SP. Comorbidities of psoriatic arthritis-metabolic syndrome and prevention: a report from the GRAPPA 2010 Annual Meeting. J Rheumatol 2012;39: 437-40.
    • (2012) J Rheumatol , vol.39 , pp. 437-440
    • Raychaudhuri, S.P.1
  • 9
    • 78651093827 scopus 로고    scopus 로고
    • A 3 mg/kg starting dose of infliximab in active spondyloarthritis resistant to conventional treatments is efficient, safe and lowers costs
    • Tenga G, Goëb V, Lequerré T, et al. A 3 mg/kg starting dose of infliximab in active spondyloarthritis resistant to conventional treatments is efficient, safe and lowers costs. Joint Bone Spine 2011;78: 50-5.
    • (2011) Joint Bone Spine , vol.78 , pp. 50-55
    • Tenga, G.1    Goëb, V.2    Lequerré, T.3
  • 10
    • 43449111187 scopus 로고    scopus 로고
    • Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1)
    • DOI 10.1016/S0140-6736(08)60725-4, PII S0140673608607254
    • Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo controlled trial (PHOENIX 1). Lancet 2008;371: 1665-74. (Pubitemid 351671883)
    • (2008) The Lancet , vol.371 , Issue.9625 , pp. 1665-1674
    • Leonardi, C.L.1    Kimball, A.B.2    Papp, K.A.3    Yeilding, N.4    Guzzo, C.5    Wang, Y.6    Li, S.7    Dooley, L.T.8    Gordon, K.B.9
  • 11
    • 43449139402 scopus 로고    scopus 로고
    • Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2)
    • DOI 10.1016/S0140-6736(08)60726-6, PII S0140673608607266
    • Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo controlled trial (PHOENIX 2). Lancet 2008;371: 1675-84. (Pubitemid 351671884)
    • (2008) The Lancet , vol.371 , Issue.9625 , pp. 1675-1684
    • Papp, K.A.1    Langley, R.G.2    Lebwohl, M.3    Krueger, G.G.4    Szapary, P.5    Yeilding, N.6    Guzzo, C.7    Hsu, M.-C.8    Wang, Y.9    Li, S.10    Dooley, L.T.11    Reich, K.12
  • 12
    • 74249094930 scopus 로고    scopus 로고
    • Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis
    • on behalf of the ACCEPT Study Group
    • Griffiths CE, Strober BE, van de Kerkhof P, et al. on behalf of the ACCEPT Study Group. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med 2010;362: 118-28.
    • (2010) N Engl J Med , vol.362 , pp. 118-128
    • Griffiths, C.E.1    Strober, B.E.2    Van De Kerkhof, P.3
  • 13
    • 60249084148 scopus 로고    scopus 로고
    • Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: Randomised, double-blind, placebo-controlled, crossover trial
    • Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet 2009;373: 633-40.
    • (2009) Lancet , vol.373 , pp. 633-640
    • Gottlieb, A.1    Menter, A.2    Mendelsohn, A.3
  • 14
    • 84883134297 scopus 로고    scopus 로고
    • Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1-year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT i trial
    • on behalf of the PSUMMIT I Study Group
    • McInnes IB, Kavanaugh A, Gottlieb AB, et al. on behalf of the PSUMMIT I Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1-year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT I trial. Lancet 2013;382: 780-9.
    • (2013) Lancet , vol.382 , pp. 780-789
    • McInnes, I.B.1    Kavanaugh, A.2    Gottlieb, A.B.3
  • 15
    • 33746951437 scopus 로고    scopus 로고
    • Classification criteria for psoriatic arthritis: Development of new criteria from a large international study
    • DOI 10.1002/art.21972
    • Taylor W, Gladman D, Helliwell P, et al. for the CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 2006;54: 2665-73. (Pubitemid 44205029)
    • (2006) Arthritis and Rheumatism , vol.54 , Issue.8 , pp. 2665-2673
    • Taylor, W.1    Gladman, D.2    Helliwell, P.3    Marchesoni, A.4    Mease, P.5    Mielants, H.6
  • 16
    • 0029044362 scopus 로고
    • American College of Rheumatology: Preliminary definition of improvement in rheumatoid arthritis
    • Felson DT, Anderson JJ, Boers M, 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
  • 17
    • 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, et al. 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
  • 19
    • 53149105544 scopus 로고    scopus 로고
    • Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
    • Aletaha D, Landewe R, Karonitsch T, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Ann Rheum Dis 2008;67: 1360-4.
    • (2008) Ann Rheum Dis , vol.67 , pp. 1360-1364
    • Aletaha, D.1    Landewe, R.2    Karonitsch, T.3
  • 20
    • 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, 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
  • 21
    • 0018099294 scopus 로고
    • Severe psoriasis - oral therapy with a new retinoid
    • Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978;157: 238-44. (Pubitemid 8387357)
    • (1978) Dermatologica , vol.157 , Issue.4 , pp. 238-244
    • Fredriksson, T.1    Pettersson, U.2
  • 23
    • 14244255744 scopus 로고    scopus 로고
    • How much improvement in functional status is considered important by patients with active psoriatic arthritis: Applying the outcome measures in rheumatoid arthritis clinical trials (OMERACT) group guidelines
    • Mease PJ, Ganguly R, Wanke L, et al. How much improvement in functional status is considered important by patients with active psoriatic arthritis: applying the outcome measures in rheumatoid arthritis clinical trials (OMERACT) group guidelines. Ann Rheum Dis 2004;63(Suppl 1):391.
    • (2004) Ann Rheum Dis , vol.63 , Issue.SUPPL. 1 , pp. 391
    • Mease, P.J.1    Ganguly, R.2    Wanke, L.3
  • 25
    • 0028575453 scopus 로고
    • A new approach to defining disease status in ankylosing spondylitis: The Bath Ankylosing Spondylitis Disease Activity Index
    • Garrett S, Jenkinson T, Kennedy LG, et al. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol 1994;21: 2286-91.
    • (1994) J Rheumatol , vol.21 , pp. 2286-2291
    • Garrett, S.1    Jenkinson, T.2    Kennedy, L.G.3
  • 26
    • 33645124111 scopus 로고    scopus 로고
    • ASAS/EULAR recommendations for the management of ankylosing spondylitis
    • Zochling J, van der Heijde D, Burgos-Vargas R, et al. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2006;65: 442-52.
    • (2006) Ann Rheum Dis , vol.65 , pp. 442-452
    • Zochling, J.1    Van Der Heijde, D.2    Burgos-Vargas, R.3
  • 27
    • 0026877917 scopus 로고
    • The MOS 36-item short-form health survey (SF-36): Conceptual framework and item selection
    • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): conceptual framework and item selection. Med Care 1992;30: 473-83.
    • (1992) Med Care , vol.30 , pp. 473-483
    • Ware Jr., J.E.1    Sherbourne, C.D.2
  • 28
    • 0028332995 scopus 로고
    • Dermatology Life Quality Index (DLQI) - A simple practical measure for routine clinical use
    • DOI 10.1111/j.1365-2230.1994.tb01167.x
    • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Exp Dermatol 1994;19: 210-16. (Pubitemid 24194579)
    • (1994) Clinical and Experimental Dermatology , vol.19 , Issue.3 , pp. 210-216
    • Finlay, A.Y.1    Khan, G.K.2
  • 29
    • 18744368778 scopus 로고    scopus 로고
    • Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis
    • Cella D, Yount S, Sorensen M, et al. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 2005;32: 811-19. (Pubitemid 40676488)
    • (2005) Journal of Rheumatology , vol.32 , Issue.5 , pp. 811-819
    • Cella, D.1    Yount, S.2    Sorensen, M.3    Chartash, E.4    Sengupta, N.5    Grober, J.6
  • 31
    • 84899922972 scopus 로고    scopus 로고
    • Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: Results of an integrated analysis of radiographic data from the phase 3, multicenter, randomized, double-blind, placebo-controlled PSUMMIT 1 and PSUMMIT 2 trials
    • Kavanaugh A, Ritchlin C, Rahman P, et al. Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicenter, randomized, double-blind, placebo-controlled PSUMMIT 1 and PSUMMIT 2 trials. Ann Rheum Dis 2014;73: 1000-6.
    • (2014) Ann Rheum Dis , vol.73 , pp. 1000-1006
    • Kavanaugh, A.1    Ritchlin, C.2    Rahman, P.3
  • 32
    • 84861481528 scopus 로고    scopus 로고
    • To switch or not to switch after a poor response to a TNFα blocker? It is not only a matter of ACR20 or ACR50
    • Buch MH, Rubbert-Roth A, Ferraccioli G. To switch or not to switch after a poor response to a TNFα blocker? It is not only a matter of ACR20 OR ACR50. Autoimmun Rev 2012;11: 558-62.
    • (2012) Autoimmun Rev , vol.11 , pp. 558-562
    • Buch, M.H.1    Rubbert-Roth, A.2    Ferraccioli, G.3
  • 33
    • 84858866631 scopus 로고    scopus 로고
    • Ustekinumab in clinical practice: Response depends on dose and previous treatment
    • Ruiz Salas V, Puig L, Alomar A. Ustekinumab in clinical practice: response depends on dose and previous treatment. J Eur Acad Dermatol Venereol 2012;26: 508-13.
    • (2012) J Eur Acad Dermatol Venereol , vol.26 , pp. 508-513
    • Ruiz Salas, V.1    Puig, L.2    Alomar, A.3
  • 34
    • 84885182023 scopus 로고    scopus 로고
    • Switching between TNF inhibitors in psoriatic arthritis: Data from the NOR-DMARD study
    • Fagerli KM, Lie E, van der Heijde D, et al. Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study. Ann Rheum Dis 2013;72: 1840-4.
    • (2013) Ann Rheum Dis , vol.72 , pp. 1840-1844
    • Fagerli, K.M.1    Lie, E.2    Van Der Heijde, D.3
  • 35
    • 84876572244 scopus 로고    scopus 로고
    • Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor α inhibitor therapy: Results from the Danish nationwide DANBIO Registry
    • Glintborg B, Ostergaard M, Krogh NS, et al. Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor α inhibitor therapy: results from the Danish nationwide DANBIO Registry. Arthritis Rheum 2013;65: 1213-23.
    • (2013) Arthritis Rheum , vol.65 , pp. 1213-1223
    • Glintborg, B.1    Ostergaard, M.2    Krogh, N.S.3
  • 36
    • 84555202364 scopus 로고    scopus 로고
    • Practical experience of ustekinumab in the treatment of psoriasis: Experience from a multicentre, retrospective case cohort study across the U.K. and Ireland
    • Laws PM, Downs AM, Parslew R, et al. Practical experience of ustekinumab in the treatment of psoriasis: experience from a multicentre, retrospective case cohort study across the U.K. and Ireland. Br J Dermatol 2012;166: 189-95.
    • (2012) Br J Dermatol , vol.166 , pp. 189-195
    • Laws, P.M.1    Downs, A.M.2    Parslew, R.3
  • 37
    • 84879994854 scopus 로고    scopus 로고
    • Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in psoriatic arthritis
    • Fénix-Caballero S, Alegre-del Rey EJ, Castaño-Lara R, et al. Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in psoriatic arthritis. J Clin Pharm Ther 2013;38: 286-93.
    • (2013) J Clin Pharm Ther , vol.38 , pp. 286-293
    • Fénix-Caballero, S.1    Alegre-Del Rey, E.J.2    Castaño-Lara, R.3
  • 38
    • 84907879972 scopus 로고    scopus 로고
    • Safety of ustekinumab from the placebo-controlled periods of psoriatic arthritis and psoriasis clinical development programs
    • Abstract 323
    • McInnes IB, Papp K, Puig L, et al. Safety of ustekinumab from the placebo-controlled periods of psoriatic arthritis and psoriasis clinical development programs. Arthritis Rheum 2013;65(Suppl):S138-9. Abstract 323.
    • (2013) Arthritis Rheum , vol.65 , Issue.SUPPL.
    • McInnes, I.B.1    Papp, K.2    Puig, L.3
  • 39
    • 84859826969 scopus 로고    scopus 로고
    • Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part i of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials
    • Lebwohl M, Leonardi C, Griffiths CE, et al. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. J Am Acad Dermatol 2012;66: 731-41.
    • (2012) J Am Acad Dermatol , vol.66 , pp. 731-741
    • Lebwohl, M.1    Leonardi, C.2    Griffiths, C.E.3
  • 40
    • 84875433817 scopus 로고    scopus 로고
    • Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: Final results from 5 years of follow-up
    • Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol 2013;168: 844-54.
    • (2013) Br J Dermatol , vol.168 , pp. 844-854
    • Papp, K.A.1    Griffiths, C.E.2    Gordon, K.3


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