Ustekinumab for the treatment of patients with active ankylosing spondylitis: results of a 28-week, prospective, open-label, proof-of-concept study (TOPAS)

Annals of the Rheumatic Diseases - Tập 73 Số 5 - Trang 817-823 - 2014
Denis Poddubnyy1, Kay-Geert A Hermann2, Johanna Callhoff3, Joachim Listing3, Joachim Sieper4
1Rheumatology, Med. Department I, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, , Berlin, Germany.
2Charité - Universitätsmedizin Berlin
3German Rheumatism Research Centre
4Campus Benjamin Franklin Charité Universitätsmedizin Berlin

Tóm tắt

Từ khóa


Tài liệu tham khảo

Braun, 2011, 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis, Ann Rheum Dis, 70, 896, 10.1136/ard.2011.151027

van der Heijde, 2011, 2010 Update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis, Ann Rheum Dis, 70, 905, 10.1136/ard.2011.151563

Braun, 2006, Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial, Ann Rheum Dis, 65, 1147, 10.1136/ard.2006.052878

Haibel, 2007, No efficacy of subcutaneous methotrexate in active ankylosing spondylitis: a 16-week open-label trial, Ann Rheum Dis, 66, 419, 10.1136/ard.2006.054098

Haibel, 2005, Six months open label trial of leflunomide in active ankylosing spondylitis, Ann Rheum Dis, 64, 124, 10.1136/ard.2003.019174

Haibel, 2005, Open label trial of anakinra in active ankylosing spondylitis over 24 weeks, Ann Rheum Dis, 64, 296, 10.1136/ard.2004.023176

Song, 2011, Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study, Ann Rheum Dis, 70, 1108, 10.1136/ard.2010.145946

Sieper, 2012, Sarilumab for the treatment of ankylosing spondylitis: results of a phase 2, randomized, double-blind, placebo-controlled, international study (ALIGN), Ann Rheum Dis, 71, 111, 10.1136/annrheumdis-2012-eular.1852

Sieper, 2014, Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials, Ann Rheum Dis, 73, 95, 10.1136/annrheumdis-2013-203559

van der Heijde, 2005, Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT), Arthritis Rheum, 52, 582, 10.1002/art.20852

van der Heijde, 2006, Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial, Arthritis Rheum, 54, 2136, 10.1002/art.21913

Davis, 2005, Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks, Ann Rheum Dis, 64, 1557, 10.1136/ard.2004.035105

Inman, 2008, Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial, Arthritis Rheum, 58, 3402, 10.1002/art.23969

Lie, 2011, Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register, Ann Rheum Dis, 70, 157, 10.1136/ard.2010.131797

Burton, 2007, Association scan of 14,500 nonsynonymous SNPs in four diseases identifies autoimmunity variants, Nat Genet, 39, 1329, 10.1038/ng.2007.17

Rahman, 2008, Association of interleukin-23 receptor variants with ankylosing spondylitis, Arthritis Rheum, 58, 1020, 10.1002/art.23389

Nair, 2009, Genome-wide scan reveals association of psoriasis with IL-23 and NF-kappaB pathways, Nat Genet, 41, 199, 10.1038/ng.311

Duerr, 2006, A genome-wide association study identifies IL23R as an inflammatory bowel disease gene, Science, 314, 1461, 10.1126/science.1135245

Appel, 2013, In situ analysis of interleukin-23- and interleukin-12-positive cells in the spine of patients with ankylosing spondylitis, Arthritis Rheum, 1522

Mei, 2011, Increased serum IL-17 and IL-23 in the patient with ankylosing spondylitis, Clin Rheumatol, 30, 269, 10.1007/s10067-010-1647-4

Romero-Sanchez, 2011, Association between Th-17 cytokine profile and clinical features in patients with spondyloarthritis, Clin Exp Rheumatol, 29, 828

Weaver, 2007, IL-17 family cytokines and the expanding diversity of effector T cell lineages, Annu Rev Immunol, 25, 821, 10.1146/annurev.immunol.25.022106.141557

Dardalhon, 2008, Role of Th1 and Th17 cells in organ-specific autoimmunity, J Autoimmun, 31, 252, 10.1016/j.jaut.2008.04.017

Baeten, 2013, Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial, Lancet, 382, 1705, 10.1016/S0140-6736(13)61134-4

Sherlock, 2012, IL-23 induces spondyloarthropathy by acting on ROR-gammat+ CD3+CD4-CD8- entheseal resident T cells, Nat Med, 18, 1069, 10.1038/nm.2817

Leonardi, 2008, 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, 371, 1665, 10.1016/S0140-6736(08)60725-4

Papp, 2008, 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, 371, 1675, 10.1016/S0140-6736(08)60726-6

Griffiths, 2010, Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis, N Engl J Med, 362, 118, 10.1056/NEJMoa0810652

Gottlieb, 2009, Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial, Lancet, 373, 633, 10.1016/S0140-6736(09)60140-9

McInnes, 2013, Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial, Lancet, 382, 780, 10.1016/S0140-6736(13)60594-2

Sandborn, 2008, A randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease, Gastroenterology, 135, 1130, 10.1053/j.gastro.2008.07.014

van der Linden, 1984, Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria, Arthritis Rheum, 27, 361, 10.1002/art.1780270401

Garrett, 1994, A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index, J Rheumatol, 21, 2286

Brandt, 2004, Development and preselection of criteria for short term improvement after anti-TNF alpha treatment in ankylosing spondylitis, Ann Rheum Dis, 63, 1438, 10.1136/ard.2003.016717

Anderson, 2001, Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis, Arthritis Rheum, 44, 1876, 10.1002/1529-0131(200108)44:8<1876::AID-ART326>3.0.CO;2-F

Lukas, 2009, Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis, Ann Rheum Dis, 68, 18, 10.1136/ard.2008.094870

Machado, 2010, Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores, Ann Rheum Dis, 70, 47, 10.1136/ard.2010.138594

Calin, 1994, A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index, J Rheumatol, 21, 2281

Jenkinson, 1994, Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index, J Rheumatol, 21, 1694

The EuroQol Group, 1990, EuroQol-–a new facility for the measurement of health-related quality of life, Health Policy, 16, 199, 10.1016/0168-8510(90)90421-9

Doward, 2007, Translation and validation of non-English versions of the Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire, Health Qual Life Outcomes, 5, 7, 10.1186/1477-7525-5-7

Kvien, 2007, Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean?, Ann Rheum Dis, 66, iii40

Heuft-Dorenbosch, 2003, Assessment of enthesitis in ankylosing spondylitis, Ann Rheum Dis, 62, 127, 10.1136/ard.62.2.127

Maksymowych, 2009, Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index, Ann Rheum Dis, 68, 948, 10.1136/ard.2007.084244

Dougados, 2011, ASAS recommendations for collecting, analysing and reporting NSAID intake in clinical trials/epidemiological studies in axial spondyloarthritis, Ann Rheum Dis, 70, 249, 10.1136/ard.2010.133488

Althoff, 2013, Active inflammation and structural change in early active axial spondyloarthritis as detected by whole-body MRI, Ann Rheum Dis, 72, 967, 10.1136/annrheumdis-2012-201545

Sandborn, 2012, Ustekinumab induction and maintenance therapy in refractory Crohn's disease, N Engl J Med, 367, 1519, 10.1056/NEJMoa1203572

Rahman, 2013, Ustekinumab improves physical function, quality of life and work productivity of patients with active psoriatic arthritis who were naïve to MTX, despite MTX therapy or previously treated with anti-TNFa: results from PSUMMIT I and PSUMMIT II, Ann Rheum Dis, 72, 671, 10.1136/annrheumdis-2013-eular.1989

Rudwaleit, 2009, The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection, Ann Rheum Dis, 68, 777, 10.1136/ard.2009.108233